Re: FDA help

[emc-p...@ieee.org]

Kim,
 
Try this FDA page:
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfthirdparty/accredit.cfm

Here is a higher level link concerning 510k that you may find useful:
 
http://www.fda.gov/MedicalDevices/Devic
RegulationandGuidance/HowtoMarketYourDe
ice/PremarketSubmissions/PremarketNotification510k/default.htm
 
Good luck,
 
Carl

On Mon, May 10, 2010 at 4:05 AM, Kim Boll Jensen k...@bolls.dk wrote:


Hi

 

FDA has certified some consultants which can help with a 510k and at 
the same
time speed up the FDA acceptance.

 

Where do I find a list of these certified companies?

 

I’m looking for one in EU close to Denmark.

 

Best regards

 

Mr. Kim Boll Jensen

Bolls Rådgivning

Ved Gadekæret 11F

DK-3660 Stenløse

 

Phone: +45 48 18 35 66

 

k...@bolls.dk

www.bolls.dk http://www.bolls.dk/ 

 

-

This message is from the IEEE Product Safety Engineering Society 
emc-pstc
discussion list. To post a message to the list, send your e-mail to
LT;emc-p...@ieee.orgGT;

All emc-pstc postings are archived and searchable on the web at
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to 
that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
Scott Douglas LT;emcp...@socal.rr.comGT;
Mike Cantwell LT;mcantw...@ieee.orgGT; 

For policy questions, send mail to:
Jim Bacher LT;j.bac...@ieee.orgGT;
David Heald LT;dhe...@gmail.comGT; 


-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to
emc-p...@ieee.org

All emc-pstc postings are archived and searchable on the web at
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
Scott Douglas emcp...@socal.rr.com
Mike Cantwell mcantw...@ieee.org 

For policy questions, send mail to:
Jim Bacher j.bac...@ieee.org
David Heald dhe...@gmail.com 

RE: FDA approval

[emc-p...@ieee.org]

Hello Kim,

If the scanned image of the skin is going to be used to make a medical
diagnosis, you definitely have a medical device, if that is the intended use
of the scanner.

I recommend that you look at the FDA classification database to see if your
product fits any of the categories at:


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm


If you cannot find a similar (predicate) device through this database, you
need to contact a consultant who is familiar with US FDA medical device
requirements. I say this because if you cannot find a predicate device, that
is used for a 510(k) notification, you will be automatically classified as a
class III device, and would have to do a Premarket Approval (PMA), unless
you get your product re-classified under the de Novo process to class I or
class II.

BTW, to answer your questions, the FDA will want EMC and Product Safety data
to support your applications. As for fees, check these web pages:

510(k)  http://www.fda.gov/cdrh/devadvice/314a.html 

PMA  http://www.fda.gov/cdrh/devadvice/pma/userfees.html 


Best regards,
Ron Wellman




From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of Kim Boll
Jensen
Sent: Tuesday, May 22, 2007 6:46 AM
To: EMC PSTC
Subject: FDA approval


Hi

Could some one help me with data on FDA approval of medical equipment.

Very short description on approval process and Fee's.

Does they require accredited EMC and electrical safety approvals?

The product is a optical scanner (like a foto copier machine) which is
scanning the patients skin through a glass.

Best regards,

Kim Boll Jensen
Bolls Rådgivning
Ved Gadekæret 11F
DK-3660 Stenløse

Tlf.:  48 18 35 66
Fax:   48 18 35 30
Mobil: 22 99 69 91

E-mail: k...@bolls.dk
web: www.bolls.dk

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Scott Douglas   emcp...@ptcnh.net
 Mike Cantwell   mcantw...@ieee.org

For policy questions, send mail to:

 Jim Bacher: j.bac...@ieee.org
 David Heald:emc-p...@daveheald.com

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Scott Douglas   emcp...@ptcnh.net
 Mike Cantwell   mcantw...@ieee.org

For policy questions, send mail to:

 Jim Bacher: j.bac...@ieee.org
 David Heald:emc-p...@daveheald.com

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

__
This email has been scanned by the MessageLabs Email Security System.
For more information please visit http://www.messagelabs.com/email 
__

RE: FDA approval

[emc-p...@ieee.org]

Just curious, as Class 1 devices do not require premarket notification,
would the mfr have to demonstrate 'clinical efficacy' ?

luck,
Brian

 -Original Message-
 From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of Jon
 Griver
 Sent: Tuesday, May 22, 2007 6:56 AM
 To: EMC PSTC
 Cc: Kim Boll Jensen
 Subject: RE: FDA approval

 Kim,

 A short description of the FDA process is given on my site at:
 http://www.601help.com/Regulatory/fda.html

 You need both safety and EMC and lot's of other information, including
 clinical efficacy. It is not a process for the faint hearted!

 Regards,

 Jon Griver
 http://www.601help.com
 The Medical Device Designers' Guide to IEC 60601-1

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Scott Douglas   emcp...@ptcnh.net
 Mike Cantwell   mcantw...@ieee.org

For policy questions, send mail to:

 Jim Bacher: j.bac...@ieee.org
 David Heald:emc-p...@daveheald.com

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

__
This email has been scanned by the MessageLabs Email Security System.
For more information please visit http://www.messagelabs.com/email 
__

Re: FDA approval

[emc-p...@ieee.org]

In message jpecimgpcjpkcjgliabaaeaedkaa@bolls.dk, dated Tue, 22 
May 2007, Kim Boll Jensen k...@bolls.dk writes:

The product is a optical scanner (like a foto copier machine) which is 
scanning the patients skin through a glass.

Not confined to scanning the gluteus maximus during office parties, I 
hope!
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
There are benefits from being irrational - just ask the square root of 2.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Scott Douglas   emcp...@ptcnh.net
 Mike Cantwell   mcantw...@ieee.org

For policy questions, send mail to:

 Jim Bacher: j.bac...@ieee.org
 David Heald:emc-p...@daveheald.com

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

__
This email has been scanned by the MessageLabs Email Security System.
For more information please visit http://www.messagelabs.com/email 
__

RE: FDA approval

[emc-p...@ieee.org]

Kim,

A short description of the FDA process is given on my site at:
http://www.601help.com/Regulatory/fda.html

You need both safety and EMC and lot's of other information, including
clinical efficacy. It is not a process for the faint hearted!

Regards,

Jon Griver
http://www.601help.com
The Medical Device Designers' Guide to IEC 60601-1







From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of Kim Boll
Jensen
Sent: Tuesday, May 22, 2007 4:46 PM
To: EMC PSTC
Subject: FDA approval


Hi

Could some one help me with data on FDA approval of medical equipment.

Very short description on approval process and Fee's.

Does they require accredited EMC and electrical safety approvals?

The product is a optical scanner (like a foto copier machine) which is
scanning the patients skin through a glass.

Best regards,

Kim Boll Jensen
Bolls Rådgivning
Ved Gadekæret 11F
DK-3660 Stenløse

Tlf.:  48 18 35 66
Fax:   48 18 35 30
Mobil: 22 99 69 91

E-mail: k...@bolls.dk
web: www.bolls.dk

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Scott Douglas   emcp...@ptcnh.net
 Mike Cantwell   mcantw...@ieee.org

For policy questions, send mail to:

 Jim Bacher: j.bac...@ieee.org
 David Heald:emc-p...@daveheald.com

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Scott Douglas   emcp...@ptcnh.net
 Mike Cantwell   mcantw...@ieee.org

For policy questions, send mail to:

 Jim Bacher: j.bac...@ieee.org
 David Heald:emc-p...@daveheald.com

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

__
This email has been scanned by the MessageLabs Email Security System.
For more information please visit http://www.messagelabs.com/email 
__

RE: FDA laser package label

[emc-p...@ieee.org]

This is a multi-part message in MIME format.
Kim:

 

For FDA labeling requirements see: 

 

file:///C:/Documents%20and%20Settings/S
ifshutz/Local%20Settings/Temporary%20In
ernet%20Files/OLK8D/FDA%20Labeling%20Re
uirements%20for%20Radiation%20Emitting%20Devices%20and%20Products.htm
file:///C:\Documents%20and%20Settings\
Lifshutz\Local%20Settings\Temporary%20I
ternet%20Files\OLK8D\FDA%20Labeling%20R
quirements%20for%20Radiation%20Emitting%20Devices%20and%20Products.htm 

 

Also read on the FDA web site the Laser Notice 41, Laser Notice 50, and for
Class 1 Laser devices exemption from recordkeeping see Laser Notice 54. 

 

Samuel Lifshutz

Manager QA

MRV Communications Inc.  

20520 Nordhoff Street

Chatsworth, CA 91311, USA

Tel: (818) 772-6235 x265

Fax: (818) 772-0576

email: slifsh...@mrv.com

Registered by QMI to ISO 9001:2000 

 

Kim Boll Jensen k...@bolls.dk wrote:

Hi All

FDA have told one of my customers that he sholud remember the package
labeling requirement for a FDA certified Class 1laser product. But I can't
find any requirements in Part 1040 or 1010: Can anyone tell me what they are
talking about ? (is it more general requirements ?)

Best regards,

Kim Boll Jensen
Bolls Rådgivning
Ved Gadekæret 11F
DK-3660 Stenløse
Denmark

Tlf.: 48 18 35 66
Fax: 48 18 35 30
Mobil: 22 99 69 91

E-mail: k...@bolls.dk
web: www.bolls.dk

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list. Website: http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions: http://listserv.ieee.org/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

Scott Douglas emcp...@ptcnh.net
Mike Cantwell mcantw...@ieee.org

For policy questions, send mail to:

Jim Bacher: j.bac...@ieee.org
David Heald: emc-p...@daveheald.com

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

 

  _  

Yahoo! Mail goes everywhere you do. Get
http://us.rd.yahoo.com/evt=31132/*http
/mobile.yahoo.com/services?promote=mail  it on your phone. -
 This message
is from the IEEE Product Safety Engineering Society emc-pstc discussion list.
Website: http://www.ieee-pses.org/ 

To post a message to the list, send your e-mail to emc-p...@ieee.org 

Instructions: http://listserv.ieee.org/request/user-guide.html 

List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators: 

Scott Douglas emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org 

For policy questions, send mail to: 

Jim Bacher: j.bac...@ieee.org David Heald: emc-p...@daveheald.com 

All emc-pstc postings are archived and searchable on the web at: 

http://www.ieeecommunities.org/emc-pstc

-  This
message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. Website: http://www.ieee-pses.org/ 

To post a message to the list, send your e-mail to emc-p...@ieee.org 


Instructions: http://listserv.ieee.org/request/user-guide.html 


List rules: http://www.ieee-pses.org/listrules.html 


For help, send mail to the list administrators: 


Scott Douglas emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org 


For policy questions, send mail to: 


Jim Bacher: j.bac...@ieee.org David Heald: emc-p...@daveheald.com 


All emc-pstc postings are archived and searchable on the web at: 


http://www.ieeecommunities.org/emc-pstc 










Kim:



For FDA labeling requirements see: 



file:///C:/Documents%20and%20Settings/SLifshutz/Local%20Settings/Temporary%20Internet%20Files/OLK8D/FDA%20Labeling%20Requirements%20for%20Radiation%20Emitting%20Devices%20and%20Products.htm



Also read on the FDA web site the Laser
Notice 41, Laser Notice 50, and for Class 1 Laser devices exemption from recordkeeping see Laser
Notice 54. 





Samuel Lifshutz

Manager QA

MRV Communications Inc.  

20520 Nordhoff Street

Chatsworth, CA 91311, USA

Tel: (818) 772-6235 x265

Fax: (818) 772-0576

email: slifsh...@mrv.com

Registered by QMI to ISO 9001:2000







Kim Boll Jensen
k...@bolls.dk wrote:





Hi All

FDA have told one of my customers that he sholud remember the package
labeling requirement for a FDA certified Class 1laser product. But I can't
find any requirements in Part 1040 or 1010: Can anyone tell me what they are
talking about ? (is it more general requirements ?)

Best regards,

Kim Boll Jensen
Bolls Rådgivning
Ved Gadekæret 11F
DK-3660 Stenløse
Denmark

Tlf.: 48 18 35 66
Fax: 48 18 35 30
Mobil: 22 99 69 91

E-mail: k...@bolls.dk
web: www.bolls.dk

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list. Website: http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Re: FDA laser package label

[emc-p...@ieee.org]

Kim
 
According to FDA's Laser Notice 50, the FDA will allow manufacturers to use
the requirements in IEC 60825-1 to determine the laser classification of a
product, how to label device, and what information to put in the user's
manual.  However, the manufacturer must still comply with the reporting and
record keeping requirements of 21 FDA Part 1002.
 
http://www.fda.gov/cdrh/comp/guidance/1346.html
 
The marking requirement is detailed in Figure 14 of IEC 60825-1.
 
Asim

Kim Boll Jensen k...@bolls.dk wrote:

Hi All

FDA have told one of my customers that he sholud remember the package
labeling requirement for a FDA certified Class 1laser product. But I can't
find any requirements in Part 1040 or 1010: Can anyone tell me what they are
talking about ? (is it more general requirements ?)

Best regards,

Kim Boll Jensen
Bolls Rådgivning
Ved Gadekæret 11F
DK-3660 Stenløse
Denmark

Tlf.: 48 18 35 66
Fax: 48 18 35 30
Mobil: 22 99 69 91

E-mail: k...@bolls.dk
web: www.bolls.dk

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list. Website: http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions: http://listserv.ieee.org/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

Scott Douglas emcp...@ptcnh.net
Mike Cantwell mcantw...@ieee.org

For policy questions, send mail to:

Jim Bacher: j.bac...@ieee.org
David Heald: emc-p...@daveheald.com

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc




  _  

Yahoo! Mail goes everywhere you do.  h
tp://us.rd.yahoo.com/evt=31132/*http://mobile.yahoo.com/services?promote=mail
Get it on your phone. - ---
 This message is from the IEEE
Product Safety Engineering Society emc-pstc discussion list. Website:
http://www.ieee-pses.org/ 

To post a message to the list, send your e-mail to emc-p...@ieee.org 


Instructions: http://listserv.ieee.org/request/user-guide.html 


List rules: http://www.ieee-pses.org/listrules.html 


For help, send mail to the list administrators: 


Scott Douglas emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org 


For policy questions, send mail to: 


Jim Bacher: j.bac...@ieee.org David Heald: emc-p...@daveheald.com 


All emc-pstc postings are archived and searchable on the web at: 


http://www.ieeecommunities.org/emc-pstc

RE: FDA Laser Class 1

[owner-emc-p...@listserv.ieee.org]

Kim -

If the laser source is not already certified, yes.

If the laser device uses a laser source of a higher class
and is not already certified as Class I, yes.

If the laser source or laser device is already certified as
Class I, no.


The term certified, as used above, is in the context of
21CFR and roughly corresponds to your term registered.


Regards,

Peter L. Tarver, PE
ptar...@ieee.org


 From: Kim Boll Jensen
 Sent: Monday, May 02, 2005 6:58 AM


 Hi all

 Is it correct that Laser Class 1 products needs
 to be registered at FDA with
 initial report and annual reports as for other classes.

 Best regards,

 Kim Boll Jensen



This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/listserv/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Scott Douglas emcp...@ptcnh.net
 Mike Cantwellmcantw...@ieee.org

For policy questions, send mail to:

 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

RE: FDA Acceptance of Faxed Signatures

[owner-emc-p...@listserv.ieee.org]

http://www.ieee-pses.org/symposium
  http://www.emc2004.org/


The following link will bring you to Senate Bill 761 that Clinton signed
into law, legalizing electronic signatures. Probably more legalese than
you would normally care to look at, but it's a start.

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=106_cong_public_la
wsdocid=f:publ229.106.pdf






From: owner-emc-p...@listserv.ieee.org
[mailto:owner-emc-p...@listserv.ieee.org]On Behalf Of Joe P Martin
Sent: Tuesday, 13 July, 2004 5:51 PM
To: emc-p...@ieee.org
Subject: FDA Acceptance of Faxed Signatures


http://www.ieee-pses.org/symposium
  http://www.emc2004.org/


Greetings,

Can someone point me in the direction of a document that states that faxed
signatures for document approvals are accepted by the FDA.

All assistance is appreciated.

Regards

Joe Martin



This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.

IEEE PSES Main Website:  http://www.ieee-pses.org/

To post a message send your e-mail to emc-p...@ieee.org

Instructions for use of the list server:

http://listserv.ieee.org/listserv/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   emc_p...@symbol.com

For policy questions, send mail to:

 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc



This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.

IEEE PSES Main Website:  http://www.ieee-pses.org/

To post a message send your e-mail to emc-p...@ieee.org

Instructions for use of the list server:

http://listserv.ieee.org/listserv/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   emc_p...@symbol.com

For policy questions, send mail to:

 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

RE: FDA registration of laser

[Ed Eszlari]

We had the same question and requested an answer from Jerome Dennis at CDRH.
Mr. Dennis referred us to Laser notice No. 42 which in the last paragraph
states:

Distributors of laser products must only comply with the recordkeeping
requirements of part 1002. Distributors need not submit initial and annual
reports described in part 1002 nor apply new certification and identification
labels to the outside of the final product.

 

Ed

Edward Eszlari

Product Safety Engineer

Bose Corporation



From: FastWave 
Reply-To: FastWave 
To: 'Kim Boll Jensen' , EMC-PSTC 
Subject: RE: FDA registration of laser 
Date: Wed, 11 Jun 2003 07:50:34 -0400 
 
 
No registration is required if: 
1) You put a Class I laser product into your product (in its entirety) and 
your product is Class I. 
2) You include the documentation that came with the laser product with your 
product. 
3) You leave all the labeling on the laser product as you received. 
 
There is an official variance published by the CDRH that outlines this - I 
will find dig this up and forward to. 
 
Regards, 
 
Bill Bisenius 
EDD, Inc. 
bi...@productsafet.com 
www.productsafeT.com 
 
 -Original Message- 
From: Kim Boll Jensen [mailto:k...@bolls.dk] 
Sent: Wednesday, June 11, 2003 4:55 AM 
To: EMC-PSTC 
Subject: FDA registration of laser 
 
  File: Kort for Kim Boll Jensen  Hi all good people 
 
Just a simple question. 
 
When using a CD or DVD driver in a product (PC or audio product) and the 
driver is FDA registered, do I need to register the final product at FDA 
too. I can't find a paragraph in 21 CFR which tells me when not to 
register. 
 
(The drives are Class I but includes a higher laser internally as fare 
as I know) 
 
 
Best regards, 
 
 
Kim Boll Jensen 
Bolls Raadgivning 
Denmark 
 
--- 
This message is from the IEEE EMC Society Product Safety 
Technical Committee emc-pstc discussion list. 
 
Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ 
 
To cancel your subscription, send mail to: 
 majord...@ieee.org 
with the single line: 
 unsubscribe emc-pstc 
 
For help, send mail to the list administrators: 
 Ron Pickard: emc-p...@hypercom.com 
 Dave Heald: emc_p...@symbol.com 
 
For policy questions, send mail to: 
 Richard Nute: ri...@ieee.org 
 Jim Bacher: j.bac...@ieee.org 
 
Archive is being moved, we will announce when it is back on-line. 
All emc-pstc postings are archived and searchable on the web at: 
 http://www.ieeecommunities.org/emc-pstc 

  _  

MSN 8 helps ELIMINATE E-MAIL VIRUSES.  http://g.msn.com/8HMDENUS/2743??PS=
Get 2 months FREE*.
--- This message is from the IEEE EMC
Society Product Safety Technical Committee emc-pstc discussion list. Visit our
web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your
subscription, send mail to: majord...@ieee.org with the single line:
unsubscribe emc-pstc For help, send mail to the list administrators: Ron
Pickard: emc-p...@hypercom.com Dave Heald: emc_p...@symbol.com For policy
questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher:
j.bac...@ieee.org Archive is being moved, we will announce when it is back
on-line. All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: FDA registration of laser

[Peter L. Tarver]

Chris -

Your rationale for not resubmitting is valid *if* the GBICs
are Certified as Class I (I haven't seen one yet that
isn't).

Your rationale for resubmitting is missing some what ifs.
Specifically, if you remove (or cover with a label) any of
the required markings or use the device outside the
manufacturers' intended application (voltage, modulation
rates, etc.).  This is all in Laser Notice 42.

With regard to modulation rates, I reviewed one
manufacturer's certifications for one of their GBICs and
discovered that the IEC60825-1, Class 1 certification was
dependant upon not having the modulation disappear.  This
did not appear in the CDRH report, but seeing this led me to
believe the risks associated with its use without fault
testing of the modulation circuitry were greater than I was
willing to accept.  Certification reports for other GBICs
from the same manufacturer did not include this caveat.

I don't know if all GBICs are subject to the same
consideration or if some fail-safes are built into them.  If
they are subject to the same consideration, it should be so
noted in their product literature and the certifications and
the manufacturers should be taken to task for putting a yoke
on end-users.



Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
San Jose, CA
peter.tar...@sanmina-sci.com


 From: Chris Maxwell
 Sent: Wednesday, June 11, 2003 11:04 AM

 our current thinking is that we don't need to
 re-submit the GBICs to the CDRH

deletia

 The only reason that I could see for
 re-submitting the GBICs would be if we tried to
 re-label them and sell them under a Nettest part
 number, which we don't.

 Does anybody see a hole in this reasoning?

 Thanks,

  Chris Maxwell



This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   emc_p...@symbol.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

Re: FDA registration of laser

[garymcintu...@aol.com]

Nope,  you are absolutely correct on the GBIC's or the new smaller pluggable
LC connector optics. You are just a distributor of those under the laser
guidelines. Again, its a fully contained module that you make no changes to,
and they have no controls or failure modes that you could induce to change the
output of the laser.
   Gary

RE: FDA registration of laser

[Chris Maxwell]

I want to leech off of this question; I hope that I don't get it off track.

We currently produce a module that use GBICs.  For the unfamiliar, a GBIC is
an optical transceiver for gigabit ethernet.  Our quality personnel handle
CDRH submissions; and our current thinking is that we don't need to re-submit
the GBICs to the CDRH for the following reasons:

1.  We don't make them.
2.  They are self contained.
3.  They are already CE marked and submitted to the CDRH by their own
manufacturer.
4.  The original manufacturer is clearly labeled on the units.
5.  They are universal and installed by the customer.   Our product could use
any appropriate GBIC.  We offer a couple of brands to our customers.  
However, to me it still wouldn't make sense for us to re-submit these brands
to the CDRH. Our customers could install any brand of GBIC.  


The only reason that I could see for re-submitting the GBICs would be if we
tried to re-label them and sell them under a Nettest part number, which we
don't.

Does anybody see a hole in this reasoning?

Thanks,

 Chris Maxwell | Design Engineer - Optical Division
email chris.maxw...@nettest.com | dir +1 315 266 5128 | fax +1 315 797 8024

NetTest | 6 Rhoads Drive, Utica, NY 13502 | USA
web www.nettest.com | tel +1 315 797 4449 | 


  



This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   emc_p...@symbol.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

Re: FDA registration of laser

[David Heald]

Kim,
  You DO need to register.  Testing may not be required, but is
strongly encouraged regardless (technically you can refer to the laser
component manufacturer's results).

Note: This is assuming that you aren't just putting an off the shelf
enclosed CD/DVD ROM drive in a system, which shouldn't require any
testing or submission.  

Best Regards,
Dave Heald


 Kim Boll Jensen k...@bolls.dk 06/11/03 04:54AM 
Hi all good people

Just a simple question.

When using a CD or DVD driver in a product (PC or audio product) and
the
driver is FDA registered, do I need to register the final product at
FDA
too. I can't find a paragraph in 21 CFR which tells me when not to
register.

(The drives are Class I but includes a higher laser internally as fare
as I know)


Best regards,


Kim Boll Jensen
Bolls Raadgivning
Denmark



This email has been scanned for computer viruses.


This email has been scanned for computer viruses.


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   emc_p...@symbol.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: FDA registration of laser

[Peter L. Tarver]

Kim -

If the drive is already certified as a Class 1 laser product
and you do not modify it or remove any of the required
markings, you don't need to do anything, irrespective of the
internal laser source's laser class.Refer to Laser
Notice 42 at

http://www.fda.gov/cdrh/radhlth/pdf/laser-notice-42.pdf

For general information on reporting requirements, refer to

http://www.fda.gov/cdrh/radhlth/summary.html

and scroll down to or search on Summary of Reporting
Requirements

or refer to

http://www.fda.gov/cdrh/radhlth/eprc_reports_and_records.htm
l

for more details.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
San Jose, CA
peter.tar...@sanmina-sci.com

 -Original Message-
 From: Kim Boll Jensen
 Sent: Wednesday, June 11, 2003 1:55 AM

 Hi all good people

 Just a simple question.

 When using a CD or DVD driver in a product (PC or
 audio product) and the
 driver is FDA registered, do I need to register
 the final product at FDA
 too. I can't find a paragraph in 21 CFR which
 tells me when not to
 register.

 (The drives are Class I but includes a higher
 laser internally as fare
 as I know)


 Best regards,


 Kim Boll Jensen
 Bolls Raadgivning
 Denmark




This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   emc_p...@symbol.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: FDA registration of laser

[FastWave]

No registration is required if:
1) You put a Class I laser product into your product (in its entirety) and
your product is Class I.
2) You include the documentation that came with the laser product with your
product.
3) You leave all the labeling on the laser product as you received.

There is an official variance published by the CDRH that outlines this - I
will find dig this up and forward to.

Regards,

Bill Bisenius
EDD, Inc.
bi...@productsafet.com
www.productsafeT.com

 -Original Message-
From:   Kim Boll Jensen [mailto:k...@bolls.dk] 
Sent:   Wednesday, June 11, 2003 4:55 AM
To: EMC-PSTC
Subject:FDA registration of laser

  File: Kort for Kim Boll Jensen  Hi all good people

Just a simple question.

When using a CD or DVD driver in a product (PC or audio product) and the
driver is FDA registered, do I need to register the final product at FDA
too. I can't find a paragraph in 21 CFR which tells me when not to
register.

(The drives are Class I but includes a higher laser internally as fare
as I know)


Best regards,


Kim Boll Jensen
Bolls Raadgivning
Denmark


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   emc_p...@symbol.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

Re: FDA registration of laser

[T.Sato]

On Wed, 11 Jun 2003 10:54:36 +0200,
  Kim Boll Jensen k...@bolls.dk wrote:

 When using a CD or DVD driver in a product (PC or audio product) and the
 driver is FDA registered, do I need to register the final product at FDA
 too. I can't find a paragraph in 21 CFR which tells me when not to
 register.

I would suggest to refer to the Laser Notice No.42 issued from CDRH, at:

  http://www.fda.gov/cdrh/radhlth/pdf/laser-notice-42.pdf

Which is titled Clarification of compliance requirements for certain
manufacturers who incorporate certified Class I laser products into
their products, and describes possible reduction of the requirements
under certain conditions.

Regards,
Tom


Tomonori Sato  vef00...@nifty.ne.jp
URL: http://member.nifty.ne.jp/tsato/


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   emc_p...@symbol.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: FDA registration of laser

[Colgan, Chris]

As far as I know, yes, you have to register the actual product with the FDA.
That's what I have always done anyway.  The fact that the driver is FDA
registered will make it a fairly simple paperwork exercise.

If you think about it, customs will not be able to associate the driver's
FDA accession number with the product it is contained in.  The product will
need it's own accession number from the FDA (if that makes sense).

Regards

Chris Colgan
Compliance Engineer
TAG McLaren Audio Ltd
The Summit, Latham Road
Huntingdon, Cambs, PE29 6ZU
*Tel: +44 (0)1480 415 627
*Fax: +44 (0)1480 52159
* Mailto:chris.col...@tagmclaren.com
* http://www.tagmclaren.com


 -Original Message-
 From: Kim Boll Jensen [SMTP:k...@bolls.dk]
 Sent: Wednesday, June 11, 2003 9:55 AM
 To:   EMC-PSTC
 Subject:  FDA registration of laser
 
 Hi all good people
 
 Just a simple question.
 
 When using a CD or DVD driver in a product (PC or audio product) and the
 driver is FDA registered, do I need to register the final product at FDA
 too. I can't find a paragraph in 21 CFR which tells me when not to
 register.
 
 (The drives are Class I but includes a higher laser internally as fare
 as I know)
 
 
 Best regards,
 
 
 Kim Boll Jensen
 Bolls Raadgivning
 Denmark  File: Kort for Kim Boll Jensen  


**  
   Please visit us at www.tagmclaren.com
**

The contents of this E-mail are confidential and for the exclusive
use of the intended recipient. If you receive this E-mail in error,
please delete it from your system immediately and notify us either
by E-mail, telephone or fax. You  should not  copy, forward or 
otherwise disclose the content of the E-mail.

Important Note: Any typographical, clerical or other error in this 
communication is subject to correction without any liability on 
the part of TAG McLaren Audio Limited. Any orders placed shall
be subject to acceptance by TAG McLaren Audio Limited on its 
standard terms and conditions of sale which shall govern the 
contract for the sale and purchase of the products ordered to the
exclusion of any other terms and conditions.

TAG McLaren Audio Ltd
The Summit, 11 Latham Road
Huntingdon, Cambs, PE29 6ZU
Telephone : 01480 415600 (+44 1480 415600)
Facsimile : 01480 52159 (+44 1480 52159)

**  
   Please visit us at www.tagmclaren.com
**



This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   emc_p...@symbol.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: FDA requirements for beauty treatment device

[Ronald R. Wellman]

Hello Peter,

This may be similar to the product in question:

http://www.alliedhealth.net/micro_ablation.htm

Best regards,
Ron Wellman

At 10:12 AM 4/9/2003 -0700, Peter L. Tarver wrote:

Nick -

this sounds like one of those electric skin/muscle toner
devices.

While I didn't find specific reference to this type of
device, it appears to be treated as a medical device and not
a cosmetic.  Refer to

http://www.cfsan.fda.gov/~dms/cos-derm.html

for another type of product that was misidentified.

The term ''device'' (except when used in paragraph (n) of
this section and in sections 301(i), 403(f), 502(c), and
602(c)) means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or
accessory, which is - (1) recognized in the official
National Formulary, or the United States Pharmacopeia, or
any supplement to them, (2) intended for use in the
diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or
other animals, or (3) intended to affect the structure or
any function of the body of man or other animals, and which
does not achieve its primary intended purposes through
chemical action within or on the body of man or other
animals and which is not dependent upon being metabolized
for the achievement of its primary intended purposes. [FDC
Act, section 201 (h)]

It appears your client's device may fit into definition (3).

To get a clear idea, refer to

http://www.fda.gov/cdrh/dsma/dsmastaf.html

and contact the FDA directly.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
San Jose, CA
peter.tar...@sanmina-sci.com



  -Original Message-
  From: Nick Williams
  Sent: Wednesday, April 09, 2003 3:51 AM
 
  I've been asked to take a look at the
  requirements for a beauty
  treatment product which the client wants to push
  for the US market.
  It works by passing a small current through the skin.
 
  The client is adamant that this is not a medical
  device in the sense
  of the EU Medical Devices requirements since they
  make no therapeutic
  claims. We have not been responsible for CE
  marking it so I'm
  reserving my own judgement on this point, but I'm
  certainly not going
  to assume that the semantic same work around will
  provide a release
  from the applicable legislative requirements in the US.
 
  I've spent sometime looking  at the FDA site this
  morning, but I'm
  having trouble find stuff which might be useful
  in among the vast
  amount of information on true medical devices and
  on cosmetics. This
  unit might best be described as a 'cosmetic
  device' If there's
  someone out there who can point me to a quick
  primer which gives
  details of what the FDA consider to be within the
  scope of their
  remit, and what the requirements are for
  equipment which is within
  their remit, this would help immensely in getting
  to grips with the
  project.
 
  Thanks
 
  Nick.
 
  P.S. As to whether it actually works or not,
  well, I haven't seen any
  changes yet, but maybe I'm just too beautiful already!
 


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
  majord...@ieee.org
with the single line:
  unsubscribe emc-pstc

For help, send mail to the list administrators:
  Ron Pickard:  emc-p...@hypercom.com
  Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
  Richard Nute:   ri...@ieee.org
  Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
 http://www.ieeecommunities.org/emc-pstc




This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

Re: FDA requirements for beauty treatment device

[Ronald R. Wellman]

Hello Nick,

I'd be curious as to what claims the manufacturer makes for this beauty 
treatment product. That may determine one thing in regards to potential 
misbranding under FDA regulations but if there are similar devices already 
on the market in the USA, I would check to see how they are classified, if 
at all. However, check out the following URL:

http://www.accessdata.fda.gov/scripts/c
rh/cfdocs/cfPCD/classification.cfm?ID=2479

This device is a Class II device and requires pre-market notification to 
the FDA by submitting a 510(k). Also, there is no such thing as a cosmetic 
device. It is either a cosmetic, a medical device, or a combination 
product. Combination products are handled by the Office of Combination 
Products at:

http://www.fda.gov/oc/combination/

Best regards,
Ron Wellman

At 11:51 AM 4/9/2003 +0100, Nick Williams wrote:

I've been asked to take a look at the requirements for a beauty treatment 
product which the client wants to push for the US market. It works by 
passing a small current through the skin.

The client is adamant that this is not a medical device in the sense of 
the EU Medical Devices requirements since they make no therapeutic claims. 
We have not been responsible for CE marking it so I'm reserving my own 
judgement on this point, but I'm certainly not going to assume that the 
semantic same work around will provide a release from the applicable 
legislative requirements in the US.

I've spent sometime looking  at the FDA site this morning, but I'm having 
trouble find stuff which might be useful in among the vast amount of 
information on true medical devices and on cosmetics. This unit might best 
be described as a 'cosmetic device' If there's someone out there who can 
point me to a quick primer which gives details of what the FDA consider to 
be within the scope of their remit, and what the requirements are for 
equipment which is within their remit, this would help immensely in 
getting to grips with the project.

Thanks

Nick.

P.S. As to whether it actually works or not, well, I haven't seen any 
changes yet, but maybe I'm just too beautiful already!

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc




This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: FDA Laser Requirements

[Steve Hsu]

Hi, Rich:

I believe it's a typo error there. It should read as 1002.1, 21CFR1002.1(c)
and Table 1 show the Applicability.


Regards,


Steve Hsu
Sr. Quality Engineer
Pine Photonics Communications
s...@pinephotonics.com



From: richwo...@tycoint.com [mailto:richwo...@tycoint.com]
Sent: Wednesday, March 05, 2003 8:56 AM
To: emc-p...@majordomo.ieee.org
Subject: FDA Laser Requirements



21CFR1002.30(b) refers to 1002.61 which does not exist. Does anyone know the
correct reference?


Richard Woods
Sensormatic Electronics
Tyco International



This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: FDA Laser Requirements

[Peter L. Tarver]

Rich -

An on-line search of those available (back to 1996) at the
GPO web site shows no sign of 1002.61.  However, my paper
copy dated 1993 shows 1002.61 is the first subparagraph of
Subpart G, Codes for Reporting Listed Electronic Products,
and 1002.61 is titled, List of specific product groups.

I can provide a scanned copy to those who wish it.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
San Jose, CA
peter.tar...@sanmina-sci.com

 -Original Message-
 From: richwo...@tycoint.com
 Sent: Wednesday, March 05, 2003 8:56 AM

 21CFR1002.30(b) refers to 1002.61 which does not
 exist. Does anyone know the
 correct reference?


 Richard Woods
 Sensormatic Electronics
 Tyco International



This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: FDA Laser Requirements

[richwo...@tycoint.com]

The FDA says the correct reference is 1002.31.

  -Original Message-
 From: WOODS, RICHARD  
 Sent: Wednesday, March 05, 2003 11:56 AM
 To:   'emc-pstc'
 Subject:  FDA Laser Requirements
 
 21CFR1002.30(b) refers to 1002.61 which does not exist. Does anyone know
 the correct reference?
 
 
 Richard Woods
 Sensormatic Electronics
 Tyco International
 


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: FDA letters of Accession - Clarification

[Peter Tarver]

John  Gary -

In point of fact, the Accession letters are *only*
acknowledgement of receipt of report materials.  The do not,
nor are they intended to convey anything about compliance.
In light of their intended function, it is reasonable to
expect they are sent automagically.  Compliance is not
mentioned in the letters.  Their value to an NRTL is in
indicating the submittal has been made.

My discussions with the CDRH evaluators indicated that, if
their review of the content of reports did not satisfy them
(something omitted, incorrect, else), you would be contacted
separately.

In my previous NRTL employment, I had caught an error in an
Initial Report to the CDRH.  The customer argued with me
regarding my labeling issue, but the CDRH confirmed my
interpretation was correct (this customer was really only
trying to cya for an simple error).  This was the only error
I found in four or five years of reviewing something around
25-35 reports, leading me to believe most submitters are on
the up  up.  (My training and instructions were to review
on more than a cursory basis, in that we verified
calculations and strove to understand the nature of the
requirements to ensure they were used properly; many of the
mathematical relations are abstruse and it must be taken for
granted that the physicists that created them knew what they
were doing.)


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
San Jose, CA
peter.tar...@sanmina-sci.com


 -Original Message-
 From: John Juhasz
 Sent: Wednesday, May 15, 2002 10:43 AM

 I feel my prior message requires clarification:

 In the last paragraph where I stated that
 the CDRH sends the review letters 'automatically',
 I would like to believe that is only in the
 cases where the CDRH felt the product complied.
 I would suspect that they wouldn't send a letter
 with such wording if the product was not compliant.

 GE Interlogix

 John A. Juhasz
 Fiber Options Div.
 Bohemia, NY



---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on browse and then emc-pstc mailing list

RE: FDA FCC

[Jim Conrad]

Jon,

If you look at Sec. 18.101  Basis and purpose, part 18 only applies to
medical equipment that emits
electromagnetic energy on frequencies within the radio frequency
spectrum in order to prevent harmful interference to authorized radio
communication services.  The Ultrasound equipment that I am familiar with
does not emit electromagnetic energy that would cause interference.  They
also comply with CISPR 11 class A or B emissions requirements depending on
where they are used.  Do you certify your Ultrasound equipment to Part 18?

Best regards,

Jim

-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Jon Griver
Sent: Monday, October 29, 2001 8:20 AM
To: emc-p...@majordomo.ieee.org
Subject: FW: FDA  FCC


Jim,

Yes and no.

Yes. Medical ultrasound equipment is explicitly included in the scope of
Part 18 under Section 18.107(f). I assume the logic is that RF circuits are
required to generate the ultrasound.

No. Section 18.121 excludes non-consumer medical ultrasound equipment,
except for a few sections of Part 18 that deal mainly with allowed
frequencies.

Best Regards,

Jon Griver
http://www.601help.com - The Medical Device Developers' Guide to IEC 60601-1



 Jon,  Ultrasound equipment does us use RF directly to treat or diagnose
 patients.  I don't believe Ultrasound equipment falls under part 18.

 The FDA is now recommending the use of IEC 60601-1-2; 2001 for EMC.

 Best regards,

 Jim

 -Original Message-
 From: owner-emc-p...@majordomo.ieee.org
 [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Jon Griver
 Sent: Sunday, October 28, 2001 2:07 AM
 To: emc-p...@majordomo.ieee.org
 Subject: FDA  FCC


 This is not quite the whole story.

 Medical devices must get FDA approval, including EMC aspects. However,
 medical equipment is also subject to FCC regulations.

 FCC Part 15 exempts medical equipment (Sec 15.103), though it is still
 subject to the general requirements of the FCC in that devices found to
 cause interference can be stopped from operating.

 Medical devices that intentionally use EM radiation are subject
 to FCC Part
 18. This includes ultrasound equipment, diathermy equipment, microwave
 therapeutic devices.

 Regards,

 Jon Griver
 http://www.601help.com - The Medical Device Developers' Guide to
 IEC 60601-1



 
  Hi,
 
  In the USA, it is the FDA.  For most medical products, the FDA
 determines
  that your product is Substantially Equivalent to a legally
  marketed device.
  This is the FDA 510(k) process.  They issue you a letter that
  allows you to
  legally market the device.
 
  For EMC, the FDA usually wants to see that you comply with IEC
  60601-1-2.
 
  Ned
 
 
  Ned Devine
  Program Manager III
  Entela, Inc.
  3033 Madison Ave. SE
  Grand Rapids, MI  49548
 
  616 248 9671 Phone
  616 574 9752 Fax
  ndev...@entela.com  e-mail
 
 
 
 
 
  -Original Message-
  From: am...@westin-emission.no [mailto:am...@westin-emission.no]
  Sent: Friday, October 26, 2001 5:15 AM
  To: emc-p...@majordomo.ieee.org
  Subject: FDA
 
 
 
  Hi all,
 
  What is the basic differences between FDA and FCC ? Don't laugh,
  yes I know
  it is a silly question, but if you want to certify medical
 equipment, are
  the requirements covered in the FDA or in the FCC regulations ?
 
  As you understand, within this field, I'm a really novice ...
 
  Best regards
  Amund Westin, Oslo/Norway
 
 
 
  ---
  This message is from the IEEE EMC Society Product Safety
  Technical Committee emc-pstc discussion list.
 
  Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/
 
  To cancel your subscription, send mail to:
   majord...@ieee.org
  with the single line:
   unsubscribe emc-pstc
 
  For help, send mail to the list administrators:
   Michael Garretson:pstc_ad...@garretson.org
   Dave Healddavehe...@mediaone.net
 
  For policy questions, send mail to:
   Richard Nute:   ri...@ieee.org
   Jim Bacher: j.bac...@ieee.org
 
  All emc-pstc postings are archived and searchable on the web at:
  No longer online until our new server is brought online and the old
  messages are imported into the new server.
 
  ---
  This message is from the IEEE EMC Society Product Safety
  Technical Committee emc-pstc discussion list.
 
  Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/
 
  To cancel your subscription, send mail to:
   majord...@ieee.org
  with the single line:
   unsubscribe emc-pstc
 
  For help, send mail to the list administrators:
   Michael Garretson:pstc_ad...@garretson.org
   Dave Healddavehe...@mediaone.net
 
  For policy questions, send mail to:
   Richard Nute:   ri...@ieee.org
   Jim Bacher: j.bac...@ieee.org
 
  All emc-pstc postings are archived and searchable on 

RE: FDA

[robertj]

Elaborating a bit, both agencies deal with electromagnetic radiation,
which is where some confusion arises.

The Food and Drug Administration deals with the health aspects of
products. As a result they worry about 
X-radiation from vacuum tubes and CRTs, diagnostic and therapeutic X-ray
equipment,
Radioactive sources such as imaging, diagnostic and radiotherapy
equipment,
Optical radiation such as lasers, tanning booths, etc,
Microwave ovens, diathermy and potentially unhealthy RF sources,
TNS (transcutaneous nerve stimulation) devices, MRI, ultrasound, etc,
Electromagnetic susceptibility of medical products such as pacemaker,
Product which claim health or healing effects, even if benign, for
example magnetic bracelets,
In general they are concerned with the safety and effectiveness of
medical products, but extend into non-medical products as noted above
like CRTs, some types of welders, lasers, etc.
And of course they handle the big fields of foods and medicines, but not
tobacco or alcohol.

The Federal Communication Commission is concerned with preserving
effective communication.
They are concerned with electromagnetic emissions and electromagnetic
susceptibility, with emphasis on interference with communications. They
try to set up the rules to prevent interference and react after the fact
to both unintentional and intentional interference sources.

Bob

-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org] On Behalf Of Price, Ed
Sent: Friday, October 26, 2001 2:53 PM
To: emc-p...@majordomo.ieee.org
Subject: RE: FDA




-Original Message-
From: Colgan, Chris [mailto:chris.col...@tagmclaren.com]
Sent: Friday, October 26, 2001 7:43 AM
To: 'am...@westin-emission.no'; emc-p...@majordomo.ieee.org
Subject: RE: FDA



The very basic difference is that the FDA are safety related 
and the FCC EMC
related.

Both have very comprehensive websites

http://www.fda.gov/

http://www.fcc.gov/

Regards

Chris Colgan
Compliance Engineer
TAG McLaren Audio Ltd
The Summit, Latham Road
Huntingdon, Cambs, PE29 6ZU
*Tel: +44 (0)1480 415 627
*Fax: +44 (0)1480 52159
* Mailto:chris.col...@tagmclaren.com
* http://www.tagmclaren.com


The FDA has several references to non-FCC standards. Here's a couple of
quotes from the FDA site:


MDS-201-0004, Electromagnetic Compatibility Standard for Medical
Devices,
October 1, 1979. This standard was developed under contract from FDA by
McDonnell Douglas, but was not adopted as mandatory; it is considered a
voluntary guideline.

Over the past 20 years, several standards applicable to medical devices
were developed with EMC requirements, primarily standards for military
products (MIL-STD), the Association for the Advancement of Medical
Instrumentation (AAMI) pacemaker standard, and a 1979 medical device EMC
standard (MDS-201-0004). The latter two standards were written under
contracts from FDA but were not adopted as mandatory; they are
considered
voluntary guidance. Recently, the international standards development
process, in which FDA has participated, has developed significant and
appropriate standards. They are not ideal, but when used, they certainly
increase product safety. Appendix B lists examples of available
standards.

CDRH encourages manufacturers of electromedical equipment to use the IEC
60601-1-2 standard, a widely recognized standard issued by the
International
Electrotechnical Commission, Geneva, Switzerland. [NOTE: IEC recently
renumbered the standards, adding 6 to all previous numbers, so
investigators may know it as IEC 601-1-2.] It is a collateral standard
to
IEC 60601-1, which is a horizontal (product family) standard intended to
apply across many medical disciplines. Other standards such as MIL-STDs
or
some industry standards may be appropriate as well. It is the
manufacturer's
responsibility to determine the most appropriate specifications and
requirements for their devices. If conformance claims have been made in
a
PMA or the labeling, however, the GMP documents should contain
documented
evidence consistent with and supporting those claims.

The IEC 60601 series currently includes a general safety standard, four
collateral standards (systems, EMC, diagnostic x-ray protection, and
programmable electrical medical systems), and over 40 particular, or
product
specific standards that adapt the general and collateral standards.
Related
international standards contain details of the IEC 60601-1-2
requirements
and test methods (e.g., International Special Committee on Radio
Interference (CISPR) standards CISPR 11 and CISPR 16, and IEC 61000-4-x
which supersedes the obsolete IEC 801-x series). FDA investigators may
be
aware of IEC 801-2, since many firms have used it to determine
requirements
for controlling ESD during manufacturing.

These standards are subject to frequent revisions and many documents
have to
be reviewed simultaneously to determine the current requirements. Hence,
manufacturers

RE: FDA FCC

[Jim Conrad]

Jon,  Ultrasound equipment does us use RF directly to treat or diagnose
patients.  I don't believe Ultrasound equipment falls under part 18.

The FDA is now recommending the use of IEC 60601-1-2; 2001 for EMC.

Best regards,

Jim

-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Jon Griver
Sent: Sunday, October 28, 2001 2:07 AM
To: emc-p...@majordomo.ieee.org
Subject: FDA  FCC


This is not quite the whole story.

Medical devices must get FDA approval, including EMC aspects. However,
medical equipment is also subject to FCC regulations.

FCC Part 15 exempts medical equipment (Sec 15.103), though it is still
subject to the general requirements of the FCC in that devices found to
cause interference can be stopped from operating.

Medical devices that intentionally use EM radiation are subject to FCC Part
18. This includes ultrasound equipment, diathermy equipment, microwave
therapeutic devices.

Regards,

Jon Griver
http://www.601help.com - The Medical Device Developers' Guide to IEC 60601-1




 Hi,

 In the USA, it is the FDA.  For most medical products, the FDA determines
 that your product is Substantially Equivalent to a legally
 marketed device.
 This is the FDA 510(k) process.  They issue you a letter that
 allows you to
 legally market the device.

 For EMC, the FDA usually wants to see that you comply with IEC
 60601-1-2.

 Ned


 Ned Devine
 Program Manager III
 Entela, Inc.
 3033 Madison Ave. SE
 Grand Rapids, MI  49548

 616 248 9671 Phone
 616 574 9752 Fax
 ndev...@entela.com  e-mail





 -Original Message-
 From: am...@westin-emission.no [mailto:am...@westin-emission.no]
 Sent: Friday, October 26, 2001 5:15 AM
 To: emc-p...@majordomo.ieee.org
 Subject: FDA



 Hi all,

 What is the basic differences between FDA and FCC ? Don't laugh,
 yes I know
 it is a silly question, but if you want to certify medical equipment, are
 the requirements covered in the FDA or in the FCC regulations ?

 As you understand, within this field, I'm a really novice ...

 Best regards
 Amund Westin, Oslo/Norway



 ---
 This message is from the IEEE EMC Society Product Safety
 Technical Committee emc-pstc discussion list.

 Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

 To cancel your subscription, send mail to:
  majord...@ieee.org
 with the single line:
  unsubscribe emc-pstc

 For help, send mail to the list administrators:
  Michael Garretson:pstc_ad...@garretson.org
  Dave Healddavehe...@mediaone.net

 For policy questions, send mail to:
  Richard Nute:   ri...@ieee.org
  Jim Bacher: j.bac...@ieee.org

 All emc-pstc postings are archived and searchable on the web at:
 No longer online until our new server is brought online and the old
 messages are imported into the new server.

 ---
 This message is from the IEEE EMC Society Product Safety
 Technical Committee emc-pstc discussion list.

 Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

 To cancel your subscription, send mail to:
  majord...@ieee.org
 with the single line:
  unsubscribe emc-pstc

 For help, send mail to the list administrators:
  Michael Garretson:pstc_ad...@garretson.org
  Dave Healddavehe...@mediaone.net

 For policy questions, send mail to:
  Richard Nute:   ri...@ieee.org
  Jim Bacher: j.bac...@ieee.org

 All emc-pstc postings are archived and searchable on the web at:
 No longer online until our new server is brought online and
 the old messages are imported into the new server.



---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old
messages are imported into the new server.


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave 

RE: FDA

[Gregg Kervill]

As with all things regulatory there are exceptions.

The FDA also test certain types of Medical Devices, and LASERs - we had a
class III LASER for a portable CDR/W.

Gregg


-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of John Juhasz
Sent: Friday, October 26, 2001 11:53 AM
To: 'Colgan, Chris'; 'am...@westin-emission.no';
emc-p...@majordomo.ieee.org
Subject: RE: FDA



How about trying the basics, definitions:

FDA  = Food  Drug Administration
FCC = Federal Communications Commission

I think that's a pretty good indication of the differences.

John Juhasz
Fiber Options
Bohemia, NY

-Original Message-
From: Colgan, Chris [mailto:chris.col...@tagmclaren.com]
Sent: Friday, October 26, 2001 10:43 AM
To: 'am...@westin-emission.no'; emc-p...@majordomo.ieee.org
Subject: RE: FDA



The very basic difference is that the FDA are safety related and the FCC EMC
related.

Both have very comprehensive websites

http://www.fda.gov/

http://www.fcc.gov/

Regards

Chris Colgan
Compliance Engineer
TAG McLaren Audio Ltd
The Summit, Latham Road
Huntingdon, Cambs, PE29 6ZU
*Tel: +44 (0)1480 415 627
*Fax: +44 (0)1480 52159
* Mailto:chris.col...@tagmclaren.com
* http://www.tagmclaren.com


 -Original Message-
 From: am...@westin-emission.no [SMTP:am...@westin-emission.no]
 Sent: 26 October 2001 10:15
 To:   emc-p...@majordomo.ieee.org
 Subject:  FDA


 Hi all,

 What is the basic differences between FDA and FCC ? Don't laugh, yes I
 know
 it is a silly question, but if you want to certify medical equipment, are
 the requirements covered in the FDA or in the FCC regulations ?

 As you understand, within this field, I'm a really novice ...

 Best regards
 Amund Westin, Oslo/Norway



 ---
 This message is from the IEEE EMC Society Product Safety
 Technical Committee emc-pstc discussion list.

 Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

 To cancel your subscription, send mail to:
  majord...@ieee.org
 with the single line:
  unsubscribe emc-pstc

 For help, send mail to the list administrators:
  Michael Garretson:pstc_ad...@garretson.org
  Dave Healddavehe...@mediaone.net

 For policy questions, send mail to:
  Richard Nute:   ri...@ieee.org
  Jim Bacher: j.bac...@ieee.org

 All emc-pstc postings are archived and searchable on the web at:
 No longer online until our new server is brought online and the old
 messages are imported into the new server.


**
   Please visit us at www.tagmclaren.com
**

The contents of this E-mail are confidential and for the exclusive
use of the intended recipient. If you receive this E-mail in error,
please delete it from your system immediately and notify us either
by E-mail, telephone or fax. You  should not  copy, forward or
otherwise disclose the content of the E-mail.

TAG McLaren Audio Ltd
The Summit, 11 Latham Road
Huntingdon, Cambs, PE29 6ZU
Telephone : 01480 415600 (+44 1480 415600)
Facsimile : 01480 52159 (+44 1480 52159)

**
   Please visit us at www.tagmclaren.com
**

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old
messages are imported into the new server..

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old
messages

RE: FDA

[John Juhasz]

How about trying the basics, definitions:

FDA  = Food  Drug Administration
FCC = Federal Communications Commission

I think that's a pretty good indication of the differences.

John Juhasz
Fiber Options
Bohemia, NY

-Original Message-
From: Colgan, Chris [mailto:chris.col...@tagmclaren.com]
Sent: Friday, October 26, 2001 10:43 AM
To: 'am...@westin-emission.no'; emc-p...@majordomo.ieee.org
Subject: RE: FDA



The very basic difference is that the FDA are safety related and the FCC EMC
related.

Both have very comprehensive websites

http://www.fda.gov/

http://www.fcc.gov/

Regards

Chris Colgan
Compliance Engineer
TAG McLaren Audio Ltd
The Summit, Latham Road
Huntingdon, Cambs, PE29 6ZU
*Tel: +44 (0)1480 415 627
*Fax: +44 (0)1480 52159
* Mailto:chris.col...@tagmclaren.com
* http://www.tagmclaren.com


 -Original Message-
 From: am...@westin-emission.no [SMTP:am...@westin-emission.no]
 Sent: 26 October 2001 10:15
 To:   emc-p...@majordomo.ieee.org
 Subject:  FDA
 
 
 Hi all,
 
 What is the basic differences between FDA and FCC ? Don't laugh, yes I
 know
 it is a silly question, but if you want to certify medical equipment, are
 the requirements covered in the FDA or in the FCC regulations ?
 
 As you understand, within this field, I'm a really novice ...
 
 Best regards
 Amund Westin, Oslo/Norway
 
 
 
 ---
 This message is from the IEEE EMC Society Product Safety
 Technical Committee emc-pstc discussion list.
 
 Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/
 
 To cancel your subscription, send mail to:
  majord...@ieee.org
 with the single line:
  unsubscribe emc-pstc
 
 For help, send mail to the list administrators:
  Michael Garretson:pstc_ad...@garretson.org
  Dave Healddavehe...@mediaone.net
 
 For policy questions, send mail to:
  Richard Nute:   ri...@ieee.org
  Jim Bacher: j.bac...@ieee.org
 
 All emc-pstc postings are archived and searchable on the web at:
 No longer online until our new server is brought online and the old
 messages are imported into the new server.


**  
   Please visit us at www.tagmclaren.com
**

The contents of this E-mail are confidential and for the exclusive
use of the intended recipient. If you receive this E-mail in error,
please delete it from your system immediately and notify us either
by E-mail, telephone or fax. You  should not  copy, forward or 
otherwise disclose the content of the E-mail.

TAG McLaren Audio Ltd
The Summit, 11 Latham Road
Huntingdon, Cambs, PE29 6ZU
Telephone : 01480 415600 (+44 1480 415600)
Facsimile : 01480 52159 (+44 1480 52159)

**  
   Please visit us at www.tagmclaren.com
**

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old
messages are imported into the new server..

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old 
messages are imported into the new server.

RE: FDA

[Ned Devine]

Hi,

In the USA, it is the FDA.  For most medical products, the FDA determines
that your product is Substantially Equivalent to a legally marketed device.
This is the FDA 510(k) process.  They issue you a letter that allows you to
legally market the device.

For EMC, the FDA usually wants to see that you comply with IEC 60601-1-2.  

Ned


Ned Devine
Program Manager III
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI  49548

616 248 9671 Phone
616 574 9752 Fax
ndev...@entela.com  e-mail





-Original Message-
From: am...@westin-emission.no [mailto:am...@westin-emission.no]
Sent: Friday, October 26, 2001 5:15 AM
To: emc-p...@majordomo.ieee.org
Subject: FDA



Hi all,

What is the basic differences between FDA and FCC ? Don't laugh, yes I know
it is a silly question, but if you want to certify medical equipment, are
the requirements covered in the FDA or in the FCC regulations ?

As you understand, within this field, I'm a really novice ...

Best regards
Amund Westin, Oslo/Norway



---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old
messages are imported into the new server.

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old 
messages are imported into the new server.

RE: FDA

[Colgan, Chris]

The very basic difference is that the FDA are safety related and the FCC EMC
related.

Both have very comprehensive websites

http://www.fda.gov/

http://www.fcc.gov/

Regards

Chris Colgan
Compliance Engineer
TAG McLaren Audio Ltd
The Summit, Latham Road
Huntingdon, Cambs, PE29 6ZU
*Tel: +44 (0)1480 415 627
*Fax: +44 (0)1480 52159
* Mailto:chris.col...@tagmclaren.com
* http://www.tagmclaren.com


 -Original Message-
 From: am...@westin-emission.no [SMTP:am...@westin-emission.no]
 Sent: 26 October 2001 10:15
 To:   emc-p...@majordomo.ieee.org
 Subject:  FDA
 
 
 Hi all,
 
 What is the basic differences between FDA and FCC ? Don't laugh, yes I
 know
 it is a silly question, but if you want to certify medical equipment, are
 the requirements covered in the FDA or in the FCC regulations ?
 
 As you understand, within this field, I'm a really novice ...
 
 Best regards
 Amund Westin, Oslo/Norway
 
 
 
 ---
 This message is from the IEEE EMC Society Product Safety
 Technical Committee emc-pstc discussion list.
 
 Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/
 
 To cancel your subscription, send mail to:
  majord...@ieee.org
 with the single line:
  unsubscribe emc-pstc
 
 For help, send mail to the list administrators:
  Michael Garretson:pstc_ad...@garretson.org
  Dave Healddavehe...@mediaone.net
 
 For policy questions, send mail to:
  Richard Nute:   ri...@ieee.org
  Jim Bacher: j.bac...@ieee.org
 
 All emc-pstc postings are archived and searchable on the web at:
 No longer online until our new server is brought online and the old
 messages are imported into the new server.


**  
   Please visit us at www.tagmclaren.com
**

The contents of this E-mail are confidential and for the exclusive
use of the intended recipient. If you receive this E-mail in error,
please delete it from your system immediately and notify us either
by E-mail, telephone or fax. You  should not  copy, forward or 
otherwise disclose the content of the E-mail.

TAG McLaren Audio Ltd
The Summit, 11 Latham Road
Huntingdon, Cambs, PE29 6ZU
Telephone : 01480 415600 (+44 1480 415600)
Facsimile : 01480 52159 (+44 1480 52159)

**  
   Please visit us at www.tagmclaren.com
**

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old 
messages are imported into the new server.

Re: FDA

[Ken Javor]

Not a dumb question at all, the FDA sets performance for medical equipment
and that includes EMC performance.  My understanding at the present time is
that requirements are a smorgasbord of commercial (CE/RE) and platform style
(CI/RI) requirements.  By platform I mean tests derived for equipments which
mount on metal vehicles with ground planes.  For instance I believe one CI
requirement is akin to MIL-STD-461E CS114, swept frequency bulk cable
injection.

--
From: am...@westin-emission.no
To: emc-p...@majordomo.ieee.org
Subject: FDA
Date: Fri, Oct 26, 2001, 4:15 AM



 Hi all,

 What is the basic differences between FDA and FCC ? Don't laugh, yes I know
 it is a silly question, but if you want to certify medical equipment, are
 the requirements covered in the FDA or in the FCC regulations ?

 As you understand, within this field, I'm a really novice ...

 Best regards
 Amund Westin, Oslo/Norway



 ---
 This message is from the IEEE EMC Society Product Safety
 Technical Committee emc-pstc discussion list.

 Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

 To cancel your subscription, send mail to:
  majord...@ieee.org
 with the single line:
  unsubscribe emc-pstc

 For help, send mail to the list administrators:
  Michael Garretson:pstc_ad...@garretson.org
  Dave Healddavehe...@mediaone.net

 For policy questions, send mail to:
  Richard Nute:   ri...@ieee.org
  Jim Bacher: j.bac...@ieee.org

 All emc-pstc postings are archived and searchable on the web at:
 No longer online until our new server is brought online and the old
 messages are imported into the new server.
 

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old 
messages are imported into the new server.

RE: FDA laser classes

[Scott Lemon]

Thanks Martin,  Notice 42 makes it clear.  I can only think the guy I talked
to at CDRH either didn't know about it or he is interpreting it to only
include the examples noted in the notice (CD players, etc. where the laser
is totally buried in the product).  My application is similar to yours where
I provide an optical communications interface which uses a Class 1 laser
module.

Regards, 

Scott Lemon 
email: sle...@caspiannetworks.com 

 -Original Message-
From: Martin Lindquist [mailto:mlind...@cisco.com]
Sent: Thursday, March 22, 2001 10:07 AM
To: emc-p...@majordomo.ieee.org
Subject: RE: FDA laser classes 



Scott,
 
  My understanding is that (for our Class I components (OC3 transceivers) at
least),  according to Notice 42 (Dec. 18, 1989), initial and annual reports
are not required if you comply with the four points listed (see actual
notice for more information):
1. No modification of performance or intended use and incorporation of
the certified product results in only the concealment of the original
manufacturer's certification and identification labels required by 1010
2. The labeling requirements of 1010 and 1040.10 would be met if the
certified product were removed from the product in which it was incorporated
3. The labeling requirements of 1040.10(g) would be met in any service
configuration of the certified product
4. The laser safety information provided by the certifying manufacturer
is distributed with the product
 
  Jumping into Table 1 of Part 1002 there is no requirements for
Distribution records.  I even went so far as to verify this (via email) with
the CDRH last year.  Note that this is for a Class I OC-3 laser module
component used by us in its intended use and manufactured by someone else
(HP, etc), where the manufacturer has done all the filing, attestations,
etc., and where the module does not contain a higher Class laser.  In other
words, according to the CDRH and Notice 42 we are a 'distributor' of the
module and thus not subject to initial and annual reports, nor is any
additional certification and identification labels required on the outside
of the final product.  
 
  Your situation may well require the 5 points you list, but take a look at
Notice 42 (and Notice 41 as well (Aug. 9, 1988)), along with the other
notices in the following PDF (link provided to me by John Juhasz).  Your
compliance contact may not have been aware of these, or he may be holding
you to a higher standard than is required by the CDRH, I can't say.  
 

Notices: 
http://www.fda.gov/cdrh/radhlth/pdf/laspol01.pdf
http://www.fda.gov/cdrh/radhlth/pdf/laspol01.pdf 
(Notice 42 is page 87 of 105)
 
Reporting form:

http://www.fda.gov/cdrh/radhlth/pdf/lasrpt0p.pdf
http://www.fda.gov/cdrh/radhlth/pdf/lasrpt0p.pdf 
 
  If nothing else, you may have learned something new today and be able to
go home early...  :)
 
Martin.
 
 
 -Original Message-
From: owner-emc-p...@ieee.org [mailto:owner-emc-p...@ieee.org]On Behalf Of
Scott Lemon
Sent: Thursday, March 22, 2001 8:00 AM
To: 'Bandele Adepoju'; 'John Juhasz'; 'Martin Lindquist'; '|Moshe Valdman'
Cc: emc-p...@majordomo.ieee.org
Subject: RE: FDA laser classes 



Bandele,
 
This is not my understanding after talking to a compliance specialist in
CDRH yesterday.  He informed me that manufacturers that incorporate class 1
lasers (which have themselves followed the required reporting requirements,
etc. per the CFR and CDRH guidelines) must still:
 
1.  file an initial product report per 1002.10
2.  file an annual report per 1002.13
3.  file a report of accidental radiation occurrences (as applicable) per
1002.20
4.  end product must have a certification label per 1010.2
5.  end product must have an ID label per 1010.3
 
He indicated that all other reporting requirements (including supplemental
reports) are not required of the end product manufacturer.
 
This seems to correlate somewhat with the Aug 23, 1985 notice (at least the
second to the last paragraph).
 
I contacted Mr. Manuel Karos at CDRH (non-medical lasers) at (301) 594-4646.
This was my understanding - it might not be a bad idea if someone else wants
to contact the office as well to substantiate and report back to the group.

Regards, 

Scott Lemon 
sle...@caspiannetworks.com 

 -Original Message-
From: Bandele Adepoju [mailto:badep...@jetstream.com]
Sent: Wednesday, March 21, 2001 8:09 PM
To: 'John Juhasz'; 'Martin Lindquist'; '|Moshe Valdman'
Cc: emc-p...@majordomo.ieee.org
Subject: RE: FDA laser classes 



Hello all,
 
Manufacturers who only incorporate certified Class 1 lasers into their
products
only need to comply with the record keeping requirements of 21CFR 1002.  
They do not need to submit initial and annual reports.
 
Regards,
 
Bandele 
Jetstream Communications, Inc. 
badep...@jetstream.com mailto:badep...@jetstream.com  

 

 

-Original Message-
From: John Juhasz [mailto:jjuh...@fiberoptions.com]
Sent: Wednesday, March 21, 2001 8:19 AM

Re: FDA laser classes

[Andrew Carson]

All

I contacted the CDRH in Feb 2000 on this very issue of incorporated
certified Class I lasers into a product. After much passing up the
management chain until I found some one who could answer the question ,
I got the following reply. As it comes form the chief of the Electronics
Products Branch, I will put faith in it being the correct CDRH view
point on the issue.

Dear Andrew Carson:

You my meet the condition specified in our laser notice 42 (attached).
If so
you would not need to report or certify you product.  Please review the
attachment, to determine if your products qualify.  Sorry for the delay
in
responding.


 LASER NOTICE 42.DOC

Collin L. Figueroa
Chief, Electronic Products Branch (HFZ-342)
Center for Devices and Radiological Health
Office of Compliance
2094 Gaither Road
Rockville, MD 20850
Phone: 301-594-4654
Fax: 301-594-4672


Martin Lindquist wrote:

  Scott,  My understanding is that (for our Class I components (OC3
 transceivers) at least),  according to Notice 42 (Dec. 18, 1989),
 initial and annual reports are not required if you comply with the
 four points listed (see actual notice for more information):1. No
 modification of performance or intended use and incorporation of the
 certified product results in only the concealment of the original
 manufacturer's certification and identification labels required by
 10102. The labeling requirements of 1010 and 1040.10 would be met
 if the certified product were removed from the product in which it was
 incorporated3. The labeling requirements of 1040.10(g) would be
 met in any service configuration of the certified product4. The
 laser safety information provided by the certifying manufacturer is
 distributed with the product  Jumping into Table 1 of Part 1002 there
 is no requirements for Distribution records.  I even went so far as to
 verify this (via email) with the CDRHlast year.  Note that this is for
 a Class I OC-3 laser module component used by us in its intended use
 and manufactured by someone else (HP, etc), where the manufacturer has
 done all the filing, attestations, etc., and where the module does not
 contain a higher Class laser.  In other words, according to the CDRH
 and Notice 42 we are a 'distributor' of the module and thus not
 subject to initial and annual reports, nor is any additional
 certification and identification labels required on the outside of the
 final product.   Your situation may well require the 5 points you
 list, but take a look at Notice 42 (and Notice 41 as well (Aug. 9,
 1988)), along with the other notices in the following PDF (link
 provided to me by John Juhasz).  Your compliance contact may not have
 been aware of these, or he may be holding you to a higher standard
 than is required by the CDRH, I can't
 say. Notices:http://www.fda.gov/cdrh/radhlth/pdf/laspol01.pdf(Notice
 42 is page 87 of 105)Reporting
 form:http://www.fda.gov/cdrh/radhlth/pdf/lasrpt0p.pdf  If nothing
 else, you may have learned something new today and be able to go home
 early...  :)Martin.-Original Message-
 From: owner-emc-p...@ieee.org [mailto:owner-emc-p...@ieee.org]On
 Behalf Of Scott Lemon
 Sent: Thursday, March 22, 2001 8:00 AM
 To: 'Bandele Adepoju'; 'John Juhasz'; 'Martin Lindquist'; '|Moshe
 Valdman'
 Cc: emc-p...@majordomo.ieee.org
 Subject: RE: FDA laser classes


  Bandele,This is not my understanding after talking to a
  compliance specialist in CDRH yesterday.  He informed me
  that manufacturers that incorporate class 1 lasers (which
  have themselves followed the required reporting
  requirements, etc. per the CFR and CDRH guidelines) must
  still:1.  file an initial product report per 1002.102.  file
  an annual report per 1002.133.  file a report of accidental
  radiation occurrences (as applicable) per 1002.204.  end
  product must have a certification label per 1010.25.  end
  product must have an ID label per 1010.3He indicated that
  all other reporting requirements (including supplemental
  reports) are not required of the end product
  manufacturer.This seems to correlate somewhat with the Aug
  23, 1985 notice (at least the second to the last
  paragraph).I contacted Mr. Manuel Karos at CDRH (non-medical
  lasers) at (301) 594-4646.  This was my understanding - it
  might not be a bad idea if someone else wants to contact the
  office as well to substantiate and report back to the
  group.Regards,

  Scott Lemon
  sle...@caspiannetworks.com

  -Original Message-
  From: Bandele Adepoju [mailto:badep...@jetstream.com]
  Sent: Wednesday, March 21, 2001 8:09 PM
  To: 'John Juhasz'; 'Martin Lindquist'; '|Moshe Valdman'
  Cc: emc-p...@majordomo.ieee.org
  Subject: RE: FDA laser classes


   Hello all,Manufacturers who only incorporate
   certified Class 1 lasers into their productsonly
   need to comply with the record keeping

RE: FDA requirements

[Constance R. Brown]

Nick,

The best site for all this information is the FDA site itself: www.fda.gov.
Click on the medical device section on the home page.
Then choose Premarket issues.
And, then approval  clearance. That will take you through the
classification process  provide you with the various requirements for
device approval in order to achieve market clearance.
You also should consider the use of recognized standards  the possibility
of third-party review.
Post market considerations can be found under the GMP/QS section. You should
also review the device design  labeling sections.
I have included the three classifications for thermometer's for you-so it
depends on the specific use of your device.
Thermometer, clinical color change, Class I, CFR 880.2900---exempt from a
510k filing
Thermometer, electronic, clinical, Class II, CFR 880.2910-requires a 510k
filing
Thermometer, clinical mercury, Class II, CFR 880.2920-class II-exempt from
510k
For Class I devices a premarket notification application (510k) is not
required before marketing the device in the US. Nonetheless, the
manufacturer is still required to register their establishment by submitting
Form FDA 2891, Initial Registration of Device Establishment, and list the
generic category of classification name of the device by submitting Form FDA
2892, Device Listing.
Some Class II devices are now exempt from premarket notification
requirements as the FDA believes its resources would be better used
elsewhere. (E.g.: 880.2920). You'll still need to complete the
above-mentioned forms.
The thermometer, electronic, clinical device (880.2910) is also a candidate
for both Accredited Persons  Mutual Recognition Agreement Programs.
Let me know if I can provide additional info for you.

Kind Regards,
Constance Brown
constance.br...@conformityassessment.com
Tel: 978-524-9890
Fax: 978-524-9898





 -Original Message-
From:   owner-emc-p...@ieee.org [mailto:owner-emc-p...@ieee.org]  On Behalf
Of Nick Williams
Sent:   Tuesday, July 04, 2000 11:15 AM
To: emc-p...@majordomo.ieee.org
Subject:FDA requirements


Can somebody give me a good pointer for resource in relation to the
US FDA requirements (i.e. what is covered, and what the requirements
are?)

I've been asked to consider what might be required for the sale of a
clinical thermometer for consumer use in the US.

Regards

Nick.


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Jim Bacher:  jim_bac...@mail.monarch.com
 Michael Garretson:pstc_ad...@garretson.org

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org




---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Jim Bacher:  jim_bac...@mail.monarch.com
 Michael Garretson:pstc_ad...@garretson.org

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org

RE: FDA requirements

[George Sparacino]

Hello Nick..

Try here as a starting point:  http://www.fda.gov/

Good Luck ,
George

-Original Message-
From: Nick Williams [mailto:nick.willi...@conformance.co.uk]
Sent: Tuesday, July 04, 2000 11:15 AM
To: emc-p...@majordomo.ieee.org
Subject: FDA requirements



Can somebody give me a good pointer for resource in relation to the 
US FDA requirements (i.e. what is covered, and what the requirements 
are?)

I've been asked to consider what might be required for the sale of a 
clinical thermometer for consumer use in the US.

Regards

Nick.


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Jim Bacher:  jim_bac...@mail.monarch.com
 Michael Garretson:pstc_ad...@garretson.org

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org

RE: FDA requirements

[Mark Schmidt]

Nick,

Check this out http://www.fda.gov/cdrh/devadvice/16.html#page_index it will
assist in classifying your medical device/equipment for the US market.

Regards,

Mark 


-Original Message-
From: Nick Williams [mailto:nick.willi...@conformance.co.uk]
Sent: Tuesday, July 04, 2000 11:15 AM
To: emc-p...@majordomo.ieee.org
Subject: FDA requirements



Can somebody give me a good pointer for resource in relation to the 
US FDA requirements (i.e. what is covered, and what the requirements 
are?)

I've been asked to consider what might be required for the sale of a 
clinical thermometer for consumer use in the US.

Regards

Nick.


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Jim Bacher:  jim_bac...@mail.monarch.com
 Michael Garretson:pstc_ad...@garretson.org

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Jim Bacher:  jim_bac...@mail.monarch.com
 Michael Garretson:pstc_ad...@garretson.org

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org

RE: FDA and LEDs

[SparacinoG]

Rich,


 -Original Message-
 From: wo...@sensormatic.com [SMTP:wo...@sensormatic.com]
 Sent: Friday, November 19, 1999 10:25 AM
 To:   emc-p...@majordomo.ieee.org
 Subject:  FDA and LEDs
 
 
 Am I correct in understanding that the FDA regulations (21 CFR Part 1040) do
 not consider LEDs to be Lasers? A Laser is defined by the FDA to be a device
 that has emissions of certain wavelengths primarily by the process of
 controlled stimulated emission. I understand that an LED does not use this
 process.  Correct.
 
 I also understand that the FDA, following the lead of IEC825, once
 considered creating performance standards for LEDs but failed to do so. Is
 that correct? Correct to date.
George

 Richard Woods
 
 -
 This message is coming from the emc-pstc discussion list.
 To cancel your subscription, send mail to majord...@ieee.org
 with the single line: unsubscribe emc-pstc (without the
 quotes).  For help, send mail to ed.pr...@cubic.com,
 jim_bac...@monarch.com, ri...@sdd.hp.com, or
 roger.volgst...@compaq.com (the list administrators).
 

-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
jim_bac...@monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).

RE: FDA and LEDs -Part 2

[John Juhasz]

Rich,

Here's some info for you . . . 

http://www.fda.gov/ohrms/dockets/98fr/032499d.txt

Read I - Background. The second paragraph answers the question in more
detail
than my previous post.

John A. Juhasz
Product Qualification 
Compliance Engr.

Fiber Options, Inc.
Bohemia, NY 11716 USA

 

-Original Message-
From: wo...@sensormatic.com [mailto:wo...@sensormatic.com]
Sent: Friday, November 19, 1999 10:25 AM
To: emc-p...@majordomo.ieee.org
Subject: FDA and LEDs



Am I correct in understanding that the FDA regulations (21 CFR Part 1040) do
not consider LEDs to be Lasers? A Laser is defined by the FDA to be a device
that has emissions of certain wavelengths primarily by the process of
controlled stimulated emission. I understand that an LED does not use this
process.

I also understand that the FDA, following the lead of IEC825, once
considered creating performance standards for LEDs but failed to do so. Is
that correct?

Richard Woods

-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
jim_bac...@monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).

RE: FDA and LEDs

[John Juhasz]

It is correct that the FDA does not treat LEDs as Lasers in 21 CFR 1040. The
same holds true in ANSI Z136. IEC 825 (now known as EN 60825) does treat
them the same. 
The FDA is still considering adopting some content of 60825 (this is still
in process) but the LED issue may not appear. 
Their basis is that has not been any documented evidence of injuries
resulting from exposure to the LEDs.

However, on the production floor of my company we have one set of safety
guidelines (based on lasers) and the LED based products are handled with the
same respect as those of lasers. 

John A. Juhasz
Product Qualification 
Compliance Engr.

Fiber Options, Inc.
Bohemia, NY 11716 USA

-Original Message-
From: wo...@sensormatic.com [mailto:wo...@sensormatic.com]
Sent: Friday, November 19, 1999 10:25 AM
To: emc-p...@majordomo.ieee.org
Subject: FDA and LEDs



Am I correct in understanding that the FDA regulations (21 CFR Part 1040) do
not consider LEDs to be Lasers? A Laser is defined by the FDA to be a device
that has emissions of certain wavelengths primarily by the process of
controlled stimulated emission. I understand that an LED does not use this
process.

I also understand that the FDA, following the lead of IEC825, once
considered creating performance standards for LEDs but failed to do so. Is
that correct?

Richard Woods

-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
jim_bac...@monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).

RE: FDA requirements

[Mark Schmidt]

Martin,

Check out http://www.fda.gov/cdrh/devadvice/dd_asist.html
http://www.fda.gov/cdrh/devadvice/dd_asist.html 

I am not aware of any emission requirements. On occasion when the 510K is
submitted and reviewed the FDA will sometimes request emissions testing. If
it never finds its way into hospital environment, then FCC requirements
should be considered since it is no longer a medical device.

Regards,

Mark Schmidt
mschm...@xrite.com mailto:mschm...@xrite.com 
Phone:  (616) 257-2469
X-Rite Incorporated
Grandville, Michigan 49418
USA
Website -  www.x-rite.com http://www.x-rite.com  


-Original Message-
From:   Martin Johnson [SMTP:calpe1...@yahoo.com]
Sent:   Friday, June 25, 1999 6:42 AM
To: emc-p...@ieee.org
Subject:FDA requirements


When producing equipment that uses flat screen (LCD) 1/4 VGA displays,
is there any requirement to meet FDA emission requirements (overall
equipment is not for medical use, and would never find its way into a
hospital environment).

I only ask as one of my collegues is quite insistent that we have to
consider the requirement (because he had to in his previous job, again
not medical equipment). Its the first time i've come across it and all
i can find on the subject are advisory guideline requirements, no
mandatory requirements.

Anybody able to shed some more light on this for me.
Web sites, any info. gratefully received.

Many Thanks

MJ.
_
Do You Yahoo!?
Get your free @yahoo.com address at http://mail.yahoo.com


-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
jim_bac...@monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).


-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
jim_bac...@monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).

RE: FDA requirements

[Crabb, John]

As far as I am aware, the FDA requirements (21CFR) relate to the emission
of X-rays from CRTs within monitors. We always state that any LCD displays
within our products are therefore exempt from the FDA requirements.

I also have on file a letter to all manufacturers and importers of
television
receivers, from the FDA, dated January 31, 1994, which states : -
Policy: It is the position of the National Center for Devices and
Radiological Health that television receivers using liquid crystal displays
and containing no high voltage vacuum tubes or other components which
can generate x radiation, are not subject to the Federal performance 
standard for television receivers (21CFR 1020.10). 

As I am sure you are aware, the FDA considers that VDUs, monitors, 
and similar products are subject to 21CFR 1020.

As an aside, given that the FDA requirements are the same as those in
UL1950,
isn't it about time you got the law changed to allow UL Listing/Recognition
to be
an acceptable substitute to the tedious FDA requirements ? In any case, I
have yet 
to get to get a reading from the front of a monitor with my Victoreen 440
RF/C 
x-ray meter.  Indeed, although I get it calibrated each year, I have no way
of 
knowing whether it is working, since I can never get a reading !! 
John Crabb, Development Excellence (Product Safety) , 
NCR  Financial Solutions Group Ltd.,  Kingsway West, Dundee, Scotland. DD2
3XX
E-Mail :john.cr...@scotland.ncr.com
Tel: +44 (0)1382-592289  (direct ). Fax +44 (0)1382-622243.   VoicePlus
6-341-2289.


 -Original Message-
 From: Martin Johnson [SMTP:calpe1...@yahoo.com]
 Sent: 25 June 1999 11:42
 To:   emc-p...@ieee.org
 Subject:  FDA requirements
 
 
 When producing equipment that uses flat screen (LCD) 1/4 VGA displays,
 is there any requirement to meet FDA emission requirements (overall
 equipment is not for medical use, and would never find its way into a
 hospital environment).
 
 I only ask as one of my collegues is quite insistent that we have to
 consider the requirement (because he had to in his previous job, again
 not medical equipment). Its the first time i've come across it and all
 i can find on the subject are advisory guideline requirements, no
 mandatory requirements.
 
 Anybody able to shed some more light on this for me.
 Web sites, any info. gratefully received.
 
 Many Thanks
 
 MJ.
 _
 Do You Yahoo!?
 Get your free @yahoo.com address at http://mail.yahoo.com
 
 
 -
 This message is coming from the emc-pstc discussion list.
 To cancel your subscription, send mail to majord...@ieee.org
 with the single line: unsubscribe emc-pstc (without the
 quotes).  For help, send mail to ed.pr...@cubic.com,
 jim_bac...@monarch.com, ri...@sdd.hp.com, or
 roger.volgst...@compaq.com (the list administrators).
 

-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
jim_bac...@monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).

RE: FDA requirements

[WOODS, RICHARD]

Martin, I have to say that I don't even know what you mean by FDA emission
guidelines. Please elaborate.

My company has installed electronic business equipment in hundreds of
hospitals and medical facilities and we have never been asked to comply with
FDA emission guidelines. Our equipment complies with FCC part 15 Class A or
Class B limits. Also, in my previous life at a major PC manufacturer, we
never considered FDA emission guidelines, and I am sure that you will find
their PCs in medical environments. So, I am at a loss as to why someone
within your own company is pressing this requirement.

--
From:  Martin Johnson [SMTP:calpe1...@yahoo.com]
Sent:  Friday, June 25, 1999 6:42 AM
To:  emc-p...@ieee.org
Subject:  FDA requirements


When producing equipment that uses flat screen (LCD) 1/4 VGA
displays,
is there any requirement to meet FDA emission requirements (overall
equipment is not for medical use, and would never find its way into
a
hospital environment).

I only ask as one of my collegues is quite insistent that we have to
consider the requirement (because he had to in his previous job,
again
not medical equipment). Its the first time i've come across it and
all
i can find on the subject are advisory guideline requirements, no
mandatory requirements.

Anybody able to shed some more light on this for me.
Web sites, any info. gratefully received.

Many Thanks

MJ.
_
Do You Yahoo!?
Get your free @yahoo.com address at http://mail.yahoo.com


-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
jim_bac...@monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).


-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
jim_bac...@monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).

RE: FDA Reports for Laser Transceivers

[Peter Merguerian]

Dear Gary,

Are you implying that UL has previously accepted the FDA letter of 
accession rather than the complete FDA Report submitted by the 
laser manufacturer?

Best Regards, Peter


From:   Gary McInturff gmcintu...@packetengines.com
To: 'pe...@itl.co.il' pe...@itl.co.il,
EMC-PST
emc-p...@majordomo.ieee.org
Subject:RE: FDA Reports for Laser Transceivers
Date sent:  Mon, 22 Mar 1999 17:01:57 -0800
Send reply to:  Gary McInturff gmcintu...@packetengines.com

 Have the vendor send the letter of ascension or whatever the FDA calls it
 directly to UL. If the vendor doesn't have it yet, be prepared for a lengthy
 delay. The FDA isn't too quick about these things for resource reasons, I
 suppose. UL has to have that information because they do not have the
 equipment to measure the light intensity. They just accept the FDA
 measurements.
   Having danced around this issue myself, and understanding the number
 of vendors that typically can provide the laser and do have the necessary
 agency stuff out of the way I routinely reject those lasers that haven't
 completed the process. The ones that I have accepted I had better need
 pretty badly.
   You didn't ask but the IEC-825 requirements and the UL requirements
 are not fully aligned. I don't know what the difference is but I know that I
 have trouble getting TUV to buy off on a laser than is just recognized and
 not yet certified. 
   Gary
 
   -Original Message-
   From:   pe...@itl.co.il [SMTP:pe...@itl.co.il]
   Sent:   Monday, March 22, 1999 12:15 PM
   To: EMC-PST
   Subject:FDA Reports for Laser Transceivers
 
   Dear All,
 
   Many of my ITE customers have usually up to six alternate Class I 
   laser transceivers which they can use in any one product. Some of 
   these are UL Recognized, others are not. In the latter case, our 
   client strives to get the FDA Reports prior to submitting their 
   products for a formal Listing investigation. UL then reviews these 
   FDA reports for completeness and accuracy and issues their 
   Listing. 
 
   1. It seems to take a very long time until my client does finally 
   succeed in getting the FDA Reports for the laser transceivers. 
   Does anyone know of any shortcut?
 
   2. Does UL archive the unrecognized FDA laser reports for use 
   when products are submitted for Listing?
 
   Any help on the above will be much appreciated.
   PETER S. MERGUERIAN
   MANAGING DIRECTOR
   PRODUCT TESTING DIVISION
   I.T.L. (PRODUCT TESTING) LTD.
   HACHAROSHET 26, P.O.B. 211
   OR YEHUDA 60251, ISRAEL
 
   TEL: 972-3-5339022
   FAX: 972-3-5339019
   E-MAIL: pe...@itl.co.il
   Visit our Website: http://www.itl.co.il
 
   -
   This message is coming from the emc-pstc discussion list.
   To cancel your subscription, send mail to majord...@ieee.org
   with the single line: unsubscribe emc-pstc (without the
   quotes).  For help, send mail to ed.pr...@cubic.com,
   j...@gwmail.monarch.com, ri...@sdd.hp.com, or
   roger.volgst...@compaq.com (the list administrators).
 
 -
 This message is coming from the emc-pstc discussion list.
 To cancel your subscription, send mail to majord...@ieee.org
 with the single line: unsubscribe emc-pstc (without the
 quotes).  For help, send mail to ed.pr...@cubic.com,
 j...@gwmail.monarch.com, ri...@sdd.hp.com, or
 roger.volgst...@compaq.com (the list administrators).
 


PETER S. MERGUERIAN
MANAGING DIRECTOR
PRODUCT TESTING DIVISION
I.T.L. (PRODUCT TESTING) LTD.
HACHAROSHET 26, P.O.B. 211
OR YEHUDA 60251, ISRAEL

TEL: 972-3-5339022
FAX: 972-3-5339019
E-MAIL: pe...@itl.co.il
Visit our Website: http://www.itl.co.il

-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
j...@gwmail.monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).

RE: RE: FDA Reports for Laser Transceivers

[Lesmeister, Glenn]

UL takes it upon themselves to verify that the laser product they are
certifying complies with the applicable FDA requirements.  This can be
anything from a simple check of the CDRH report to a complete evaluation and
measurements of the laser.  I believe at least some of their offices have
the proper test equipment.

Generally, these laser transceivers in question are complete laser products
in themselves and are separately certified by their respective
manufacturer's.  As long as the manufacturer gets UL Recognition also, you
should expect that UL has already verified FDA compliance, and thus in the
end product, the transceiver should be treated just like a CD ROM used in
PC.  Of course if you have a non UL Recognized transceiver, they'll most
likely want to see the CDRH report.

Glenn


-Original Message-
From:   s_doug...@ecrm.com [mailto:s_doug...@ecrm.com]
Sent:   Tuesday, March 23, 1999 8:01 AM
To: emc-p...@majordomo.ieee.org
Subject:Re: RE: FDA Reports for Laser Transceivers

In the past I have had my problems with UL and lasers. 

The FDA does not measure laser energy. The CDRH (part of the
FDA) collects
reports of laser products from manufacturers. These reports
are 25 pages
long and filled with technical information about the
product. There are
usually a significant number of attachments to each report.
The CDRH
reviews these reports. If there are questions about
completeness or
accuracy, the CDRH will ask for further information. If they
have no
questions about the submitted data, the report is simply
filed for future
use. Each report is assigned an ACCESSION number. Also, CDRH
does not
evaluate laser systems or laser product with an eye toward
product
safety of the EN 60950 type, they only look at laser light
issues.

My question is, has UL added standards or other expertise
that they can
use to evaluate lasers, laser safety and accuracy of the
CDRH reports?
That was my question a decade ago and I see it comes to
light once again.

BTW, obtaining CDRH reports for any given laser product or
laser system is
best done by contacting the manufacturer. They are
interested in selling
their products and if that is a condition of the sale, they
will usually
comply. However, don't expect to get these reports on laser
diodes as a
component, only on laser systems or laser products.




Scott
s_doug...@ecrm.com


gmcintu...@packetengines.com writes:
Have the vendor send the letter of ascension or whatever
the FDA calls it
directly to UL. If the vendor doesn't have it yet, be
prepared for a
lengthy
delay. The FDA isn't too quick about these things for
resource reasons, I
suppose. UL has to have that information because they do
not have the
equipment to measure the light intensity. They just accept
the FDA
measurements.
   Having danced around this issue myself, and
understanding the number
of vendors that typically can provide the laser and do have
the necessary
agency stuff out of the way I routinely reject those lasers
that haven't
completed the process. The ones that I have accepted I had
better need
pretty badly.
   You didn't ask but the IEC-825 requirements and the
UL requirements
are not fully aligned. I don't know what the difference is
but I know
that I
have trouble getting TUV to buy off on a laser than is just
recognized and
not yet certified. 
   Gary

   -Original Message-
   From:   pe...@itl.co.il [SMTP:pe...@itl.co.il]
   Sent:   Monday, March 22, 1999 12:15 PM
   To: EMC-PST
   Subject:FDA Reports for Laser Transceivers

   Dear All,

   Many of my ITE customers have usually up to six
alternate Class I 
   laser transceivers which they can use in any one
product. Some of 
   these are UL Recognized, others are not. In the
latter case, our 
   client strives to get the FDA Reports prior to
submitting their 
   products for a formal Listing investigation. UL then
reviews these 
   FDA reports for completeness and accuracy and issues

Re: RE: FDA Reports for Laser Transceivers

[Scott Douglas]

In the past I have had my problems with UL and lasers. 

The FDA does not measure laser energy. The CDRH (part of the FDA) collects
reports of laser products from manufacturers. These reports are 25 pages
long and filled with technical information about the product. There are
usually a significant number of attachments to each report. The CDRH
reviews these reports. If there are questions about completeness or
accuracy, the CDRH will ask for further information. If they have no
questions about the submitted data, the report is simply filed for future
use. Each report is assigned an ACCESSION number. Also, CDRH does not
evaluate laser systems or laser product with an eye toward product
safety of the EN 60950 type, they only look at laser light issues.

My question is, has UL added standards or other expertise that they can
use to evaluate lasers, laser safety and accuracy of the CDRH reports?
That was my question a decade ago and I see it comes to light once again.

BTW, obtaining CDRH reports for any given laser product or laser system is
best done by contacting the manufacturer. They are interested in selling
their products and if that is a condition of the sale, they will usually
comply. However, don't expect to get these reports on laser diodes as a
component, only on laser systems or laser products.




Scott
s_doug...@ecrm.com


gmcintu...@packetengines.com writes:
Have the vendor send the letter of ascension or whatever the FDA calls it
directly to UL. If the vendor doesn't have it yet, be prepared for a
lengthy
delay. The FDA isn't too quick about these things for resource reasons, I
suppose. UL has to have that information because they do not have the
equipment to measure the light intensity. They just accept the FDA
measurements.
   Having danced around this issue myself, and understanding the number
of vendors that typically can provide the laser and do have the necessary
agency stuff out of the way I routinely reject those lasers that haven't
completed the process. The ones that I have accepted I had better need
pretty badly.
   You didn't ask but the IEC-825 requirements and the UL requirements
are not fully aligned. I don't know what the difference is but I know
that I
have trouble getting TUV to buy off on a laser than is just recognized and
not yet certified. 
   Gary

   -Original Message-
   From:   pe...@itl.co.il [SMTP:pe...@itl.co.il]
   Sent:   Monday, March 22, 1999 12:15 PM
   To: EMC-PST
   Subject:FDA Reports for Laser Transceivers

   Dear All,

   Many of my ITE customers have usually up to six alternate Class I 
   laser transceivers which they can use in any one product. Some of 
   these are UL Recognized, others are not. In the latter case, our 
   client strives to get the FDA Reports prior to submitting their 
   products for a formal Listing investigation. UL then reviews these 
   FDA reports for completeness and accuracy and issues their 
   Listing. 

   1. It seems to take a very long time until my client does finally 
   succeed in getting the FDA Reports for the laser transceivers. 
   Does anyone know of any shortcut?

   2. Does UL archive the unrecognized FDA laser reports for use 
   when products are submitted for Listing?

   Any help on the above will be much appreciated.
   PETER S. MERGUERIAN
   MANAGING DIRECTOR
   PRODUCT TESTING DIVISION
   I.T.L. (PRODUCT TESTING) LTD.
   HACHAROSHET 26, P.O.B. 211
   OR YEHUDA 60251, ISRAEL

   TEL: 972-3-5339022
   FAX: 972-3-5339019
   E-MAIL: pe...@itl.co.il
   Visit our Website: http://www.itl.co.il




-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
j...@gwmail.monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).

RE: FDA Reports for Laser Transceivers

[Gary McInturff]

Have the vendor send the letter of ascension or whatever the FDA calls it
directly to UL. If the vendor doesn't have it yet, be prepared for a lengthy
delay. The FDA isn't too quick about these things for resource reasons, I
suppose. UL has to have that information because they do not have the
equipment to measure the light intensity. They just accept the FDA
measurements.
Having danced around this issue myself, and understanding the number
of vendors that typically can provide the laser and do have the necessary
agency stuff out of the way I routinely reject those lasers that haven't
completed the process. The ones that I have accepted I had better need
pretty badly.
You didn't ask but the IEC-825 requirements and the UL requirements
are not fully aligned. I don't know what the difference is but I know that I
have trouble getting TUV to buy off on a laser than is just recognized and
not yet certified. 
Gary

-Original Message-
From:   pe...@itl.co.il [SMTP:pe...@itl.co.il]
Sent:   Monday, March 22, 1999 12:15 PM
To: EMC-PST
Subject:FDA Reports for Laser Transceivers

Dear All,

Many of my ITE customers have usually up to six alternate Class I 
laser transceivers which they can use in any one product. Some of 
these are UL Recognized, others are not. In the latter case, our 
client strives to get the FDA Reports prior to submitting their 
products for a formal Listing investigation. UL then reviews these 
FDA reports for completeness and accuracy and issues their 
Listing. 

1. It seems to take a very long time until my client does finally 
succeed in getting the FDA Reports for the laser transceivers. 
Does anyone know of any shortcut?

2. Does UL archive the unrecognized FDA laser reports for use 
when products are submitted for Listing?

Any help on the above will be much appreciated.
PETER S. MERGUERIAN
MANAGING DIRECTOR
PRODUCT TESTING DIVISION
I.T.L. (PRODUCT TESTING) LTD.
HACHAROSHET 26, P.O.B. 211
OR YEHUDA 60251, ISRAEL

TEL: 972-3-5339022
FAX: 972-3-5339019
E-MAIL: pe...@itl.co.il
Visit our Website: http://www.itl.co.il

-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
j...@gwmail.monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).

-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.org
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
j...@gwmail.monarch.com, ri...@sdd.hp.com, or
roger.volgst...@compaq.com (the list administrators).

RE: FDA Requirements

[Burns, Jack]

In a past life I was with a company that made deep fryers.  Though the
tanks were SS, we made the lids of aluminum, but they had to be 1100
series (unalloyed) aluminum to meet the requirements.  Unfortunately, I
don't remember what requirements.

Jack M. Burns, PE, CSP  
Product Safety Engineer  
Eaton Corporation 
ph:512 248-2851
fax:   512 248-2050
email: jbu...@aus.etn.com





 -Original Message-
 From: Mike Morrow [SMTP:mmor...@compuserve.com]
 Sent: Thursday, August 27, 1998 8:04 AM
 To:   IEEE EMC Board
 Subject:  FDA Requirements
 
 I've always been told that any piece of equipment being used in a 
 sanitary application (i.e. food processing, etc) must be constructed
 of 
 stainless steel.  I'm after the actual standard that has this 
 requirement.  Can aluminum be used??
 
 Any help is appreciated.
 
 Mike Morrow
 Product Standards Engineer
 Data Instruments
 mike_mor...@datainstruments.com
 mmor...@compuserve.com
 Phone 978-264-9550 xt-201
 Fax 978-263-0630
 
 
 -
 This message is coming from the emc-pstc discussion list.
 To cancel your subscription, send mail to majord...@ieee.com
 with the single line: unsubscribe emc-pstc (without the
 quotes).  For help, send mail to ed.pr...@cubic.com,
 ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list
 administrators).

-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.com
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list
administrators).

Re: FDA Requirements

[jim palec]

Mike,

I also found the subject of sanitary to be somewhat elusive.  Try 
the 3A standards from the International Association of Milk, Food, 
and Environmental Sanitarians or the Food, Drug,  Beverage 
Equipment Sanitary Standard #ASMI/ASME F2.1-1982.  The standards 
will also require/specify finishes to contact materials that are in 
the 15 to 35RA range depending on application.

Regards, Jim


  From: Mike Morrow mmor...@compuserve.com
  Subject: FDA Requirements 
  Date: Thu, 27 Aug 1998 09:03:58 -0400 
  To: IEEE EMC Board emc-p...@ieee.org


I've always been told that any piece of equipment being used in a 
sanitary application (i.e. food processing, etc) must be 
constructed of 
stainless steel.  I'm after the actual standard that has this 
requirement.  Can aluminum be used??

Any help is appreciated.

Mike Morrow
Product Standards Engineer
Data Instruments
mike_mor...@datainstruments.com
mmor...@compuserve.com
Phone 978-264-9550 xt-201
Fax 978-263-0630



-
Jim Palec - Electronics Group Leader
Stock Equipment Co. Chagrin Falls,OH 44023
E-mail(work): jim palec pa...@stock.com
  work ph 440-543-6000 x517, fax 440-543-4624 



-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.com
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list
administrators).

RE: FDA Requirements

[Darrell Locke (MSMail)]

Mike,

I posed this question to the group a few weeks back.  See the archive
postings for July 28 and 29 for responses.   I also did research and
could not come up with any written requirements for stainless steel.  It
seems to just be a commonly accepted practice.

Darrell Locke
Advanced Input Devices
 --
From: Mike Morrow
To: IEEE EMC Board
Subject: FDA Requirements
List-Post: emc-pstc@listserv.ieee.org
Date: Thursday, August 27, 1998 6:03AM

I've always been told that any piece of equipment being used in a
sanitary application (i.e. food processing, etc) must be constructed
of
stainless steel.  I'm after the actual standard that has this
requirement.  Can aluminum be used??

Any help is appreciated.

Mike Morrow
Product Standards Engineer
Data Instruments
mike_mor...@datainstruments.com
mmor...@compuserve.com
Phone 978-264-9550 xt-201
Fax 978-263-0630


 -
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.com
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list
administrators).

-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.com
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list
administrators).

RE: FDA requirements

[Bandele]

Dear Rebeca Chan,

Based on the information that you provided, a device such as your electrode 
device could be classified as a Class I device. A submittal to FDA under a 510k 
plan may or may not be necessary. It is hard to say with the limited 
information provided. The key question here is how does it attach to the skin 
to record electrical signals.  A product type search may be necessary to 
determine if  it is similar to a device that is on the market in the United 
States. The thing to note for design here, is to ensure that your device is 
substantially equivalent in functionality to the device on the market (or 
precursory device).  A function to function comparison must be made to 
determine equivalency.  Your device will be subject to the same requirements as 
the precursory device.  So you will also need to take special note as to what  
the special requirements of the precursory device are.  You may find these to 
be more limited to what you will like to be applied to your device.  

The drawback to this is if a thorough comparison of your device to the 
precursory is not made and you fail to recognize some critical deviations in 
your device functionality, the FDA may by default conclude that your device is 
not substantially equivalent to the precursory device. Your device could  be 
upgraded to where it requires PMA (PreMaket Approval) . If possible, you want 
to avoid the PMA (Class III) or 510k (Class II) route.  It is important to 
understand how the FDA reaches its decisions regarding substantial equivalence.

Manufacturers of devices classified as Class II or Class III (and some Class 
I), are required to register their facilities and conform to the GMP (Good 
manufacturing Practices) regulations.  ISO 9000 will go a long way as a good 
start towards satisfying this requirement.  Please note that some devices 
classified as Class I are exempted from this requirement.  Your device may fall 
in the exempted group.  

I hope this helps in answering your questions.

Best Regards,


Bandele Adepoju
Rockford Engineering Services, Inc.
Tel:001-301-855-1375
Fax:001-410-586-1460
Email:  band...@resemc.com
Web;www.resemc.com

--
From:  becky...@aol.com [SMTP:becky...@aol.com]
Sent:  Thursday, August 13, 1998 4:32 PM
To:  emc-p...@majordomo.ieee.org
Subject:  FDA requirements


I am working on a machine that has electrodes that are attached to the skin to
measure various electrical signals.  This machine is battery powered.  My
question is :  am I required to conform to any FDA design rules in this area ?
When the machine goes into production, do I have to find a manufacturer that
is specifically qualified to produce medical device ?  Is a ISO9000
certification sufficient qualification for a manufacturer to produce this item
?

Rebeca Chan


-
This message is coming from the emc-pstc discussion list.
To cancel your subscription, send mail to majord...@ieee.com
with the single line: unsubscribe emc-pstc (without the
quotes).  For help, send mail to ed.pr...@cubic.com,
ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list
administrators).

RE: FDA Modernization Program

[Mike Hopkins]

Try http://www.fda.gov/cdrh/ode/parad501.html I think that will give you
the complete information. You can also try www.aami.org.


Mike Hopkins
mhopk...@keytek.com


 -Original Message-
 From: sitar...@kodak.com [SMTP:sitar...@kodak.com]
 Sent: Thursday, March 26, 1998 3:51 PM
 To:   emc-p...@majordomo.ieee.org
 Cc:   2203...@knotes.kodak.com
 Subject:  FDA Modernization Program
 
 
 
 
 
 From Lotus Notes user: Michael J Sitarski
 
 Does anyone know about the FDA Modernization Program regarding Medical
 Devices?  Does it pertain to EMC?  Can you direct me to a source of
 further
 information?  Thank you in advance for your responses.

Re: FDA Modernization Program

[martinjp]

 Michael,
 
 Try the FDA website at www.fda.gov
 
 Joe Martin
 marti...@perkin-elmer.com


__ Reply Separator _
Subject: FDA Modernization Program
Author:  sitar...@kodak.com at INTERNET
List-Post: emc-pstc@listserv.ieee.org
Date:3/26/98 12:40 PM


 
From Lotus Notes user: Michael J Sitarski
 
Does anyone know about the FDA Modernization Program regarding Medical 
Devices?  Does it pertain to EMC?  Can you direct me to a source of further 
information?  Thank you in advance for your responses.