Re: FDA help

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

RE: FDA approval

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:

RE: FDA approval

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

Re: FDA approval

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

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

RE: FDA laser package label

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

Re: FDA laser package label

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

RE: FDA Laser Class 1

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

RE: FDA Acceptance of Faxed Signatures

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.

RE: FDA registration of laser

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

RE: FDA registration of laser

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

Re: FDA registration of laser

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

RE: FDA registration of laser

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: FDA registration of laser

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

RE: FDA registration of laser

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

RE: FDA registration of laser

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

Re: FDA registration of laser

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

RE: FDA registration of laser

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

RE: FDA requirements for beauty treatment device

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

Re: FDA requirements for beauty treatment device

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

RE: FDA Laser Requirements

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:

RE: FDA Laser Requirements

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

RE: FDA Laser Requirements

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

RE: FDA letters of Accession - Clarification

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

RE: FDA FCC

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

RE: FDA

] 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 FCC

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

RE: FDA

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

RE: FDA

...@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

RE: FDA

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

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

Re: FDA

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

RE: FDA laser classes

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

Re: FDA laser classes

...@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

RE: FDA requirements

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

RE: FDA requirements

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

RE: FDA requirements

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

RE: FDA and LEDs

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

RE: FDA and LEDs -Part 2

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

RE: FDA and LEDs

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

RE: FDA requirements

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

RE: FDA requirements

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

RE: FDA requirements

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

RE: FDA Reports for Laser Transceivers

' 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

RE: RE: FDA Reports for Laser Transceivers

[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

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

RE: FDA Reports for Laser Transceivers

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

RE: FDA Requirements

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

Re: FDA Requirements

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

RE: FDA Requirements

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

RE: FDA requirements

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

RE: FDA Modernization Program

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:

Re: FDA Modernization Program

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: