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 > 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 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 > requirements of 21CFR 1002. They do not need to > submit initial and annual reports.Regards, > > Bandele > Jetstream Communications, Inc. > 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 noticeto laser product > manufacturers."Also, the genreal > record-keeping is still required, not to > mention that youmust, 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 minimumI 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 JuhaszFiber > OptionsBohemia, 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] > > 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/ > > 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/ > click on "Virtual > Conference Hall," > -- Andrew Carson - Product Safety Engineer Xyratex Engineering Laboratory Tele 023 92496855 Fax 023 92496014
