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: 'Martin Lindquist'; emc-p...@majordomo.ieee.org Subject: RE: FDA laser classes It is true in that case that the 'reporting requirements' are not required, PROVIDED: " . . . the exempted models meet the criteria stated in its August 23, 1985 notice to laser product manufacturers." Also, the genreal record-keeping is still required, not to mention that you must, at minimum be able to demonstrate that your product meets this criteria. As such, since the product report form is rather simple to fill out, at minimum I would complete it as if I was making a filing and add it to the product's compliance folder. In case there's any question regarding the exemption of your product, you can prove it. You have the data. The opinions expressed here are mine only, and do not necessarily reflect those of my employer. John Juhasz Fiber Options Bohemia, NY -----Original Message----- From: Martin Lindquist [mailto:mlind...@cisco.com] Sent: Wednesday, March 21, 2001 10:44 AM To: John Juhasz; emc-p...@majordomo.ieee.org Subject: RE: FDA laser classes John, Isn't there an exception if the laser (Class I) is embodied in a component purchased from a manufacturer that has filed with the CDRH? I chased this about a year or two and that was what I found (cf. Notice 41 & 42). Of course, devices over Class I still have to be filed for by the end manufacturer. Also, IEC 60825 excludes devices that do not exceed Class I emission levels from regulation, except where the device is a Class II with interlocks or other safeguards that make it a Class I exposure level. In this case it is specifically included, as a Class II device if I remember. Its been a while, but I think that's it... Martin. -----Original Message----- From: owner-emc-p...@ieee.org [mailto:owner-emc-p...@ieee.org]On Behalf Of John Juhasz Sent: Wednesday, March 21, 2001 7:18 AM To: '|Moshe Valdman'; emc-p...@majordomo.ieee.org Subject: RE: FDA laser classes All of them . . . If your product(s) incorporates a laser, it is required that a product report be filed with the FDA's CDRH (Center for Devices and Radiological Health). From then on it is required to file an annual report that lists all the products that you have declared to the CDRH, quantities sold, and their status. John Juhasz Fiber Options Bohemia, NY -----Original Message----- From: |Moshe Valdman [ mailto:mvald...@netvision.net.il <mailto:mvald...@netvision.net.il> ] Sent: Tuesday, March 20, 2001 4:22 PM To: emc-p...@majordomo.ieee.org Subject: FDA laser classes Hello everyone, Of the laser classes (1,2 ,3A, 3B) etc, for which does the FDA require a report / yearly report? Thanks in advance, Moshe ------------------------------------------- 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/ <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 Heald davehe...@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/ <http://www.rcic.com/> click on "Virtual Conference Hall,"
