RE: FDA laser classes
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 To:
RE: EMC documentation for Australia
The following requirements are for those products that must be C-tick marked * Your Australian representative must apply for approval to use the C-tick marking * Anyone may apply the marking once approval is granted * Depending on the method of identification of the manufacture as noted in the application, you may have to also apply an N number adjacent to the C-tick marking. * The DoC must be issued by the Australian representative -- From: plaw...@west.net Sent: Thursday, March 22, 2001 3:51 PM To: EMC-PSTC Subject: EMC documentation for Australia Our company makes open frame linear and switch-mode component power supplies in the range of 5-500W. Applications include industrial, and medical equipment. The sales distributor we use in Australia has contacted us asking for EMC documentation to support C-Tick marking of our products, as required by the ACA (Australian Communications Authority). They are asking for an EMC test report and declaration of conformity showing that the converter complies with the relevant EMC standard. I want to verify what, if any, documentation is required for a product like ours. I have copies of several EMC-related documents from the ACA web site. Unfortunately, I can't tell if component power supplies require the same level of documentation as completed systems. 1) It appears that the regulations do covers power supplies, as discussed in the ACA EMC FAQ at http://www.aca.gov.au/consumer/faq/emc.htm. Is this accurate? 1) What is the definition of a 'Converter'? The EMC FAQ located at http://www.aca.gov.au/consumer/faq/emc.htm says that Converters that use linear technology fall within the scope of AS 1044 if they are designed for connection to a low voltage electrical supply. Does this mean that our linear-mode power supply (i.e., isolation transformer with bulk storage capacitor, series pass regulator, LM7805 regulator, etc.) must comply with that CISPR14-like standard, while the ITE-related end use may need to conform with a CISPR22-like standard? 2) Some of our power supplies were designed to meet only the conducted emission portion of the EMC specification, not the radiated emission portion. Therefore, we can't claim full compliance with the emission standard. Does this imply that the power supply must be redesigned, or no units can shipped to Australia? 3) Do we put the C-Tick mark on our products, or is this an issue for our Australian partner? --- 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: http://www.rcic.com/ click on Virtual Conference Hall, --- 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: http://www.rcic.com/ click on Virtual Conference Hall,
RE: Translation Requirements
Safety related instructions for the user should be in the vernacular under 73/23/EEC. There is more latitude on language for safety-related instructions for an 'installer'. However if installer's instructions have life-threatening consequences you reduce legal exposure by using a widely-understood language of your target country. David -Original Message- From: Finn, Paul [mailto:fi...@pan0.panametrics.com] Sent: Thursday, March 22, 2001 1:35 PM To: 'emc-pstc' Subject: Translation Requirements Can some one point out the specific requirements, if any, that are imposed on translating manuals into the language of the country they are to be used. Specifically if you CE label in accordance with 89/336/EEC (EN 61326) and 73/23/EEC (1010-1). In reviewing the archives I could only find mention that the manufacturer is to supply a version of the manual which is agreed upon in that country and English is most common. Your comments would be greatly appreciated. Paul Finn Panametrics Inc. --- 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: http://www.rcic.com/ click on Virtual Conference Hall, --- 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: http://www.rcic.com/ click on Virtual Conference Hall,
RE: Translation Requirements
Paul, This is not from the EMC or LVD , but you mentioned 1010-1 which includes laboratory equipment, so for the medical directives, including the one for in vitro diagnostic medical devices, it is very clearly specified. For the MDD, See article 4, paragraph 4 Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use. For the IVDD, See article 4, paragraph 4 Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user. 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: Finn, Paul [mailto:fi...@pan0.panametrics.com] Sent: Thursday, March 22, 2001 1:35 PM To: 'emc-pstc' Subject: Translation Requirements Can some one point out the specific requirements, if any, that are imposed on translating manuals into the language of the country they are to be used. Specifically if you CE label in accordance with 89/336/EEC (EN 61326) and 73/23/EEC (1010-1). In reviewing the archives I could only find mention that the manufacturer is to supply a version of the manual which is agreed upon in that country and English is most common. Your comments would be greatly appreciated. Paul Finn Panametrics Inc. --- 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: http://www.rcic.com/ click on Virtual Conference Hall, --- 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: http://www.rcic.com/ click on Virtual Conference Hall,
Re: FDA laser classes
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
