Hi Gary, The FDA makes it clear that they DO NOT assess conformity of laser products; the letter of accession is merely an acknowledgement that a product report or supplemental report has been received and filed. I'm not sure what you're hoping for, but perhaps you should ask the vendor for the actual report, and judge conformity for yourself based on said report. If you're looking for an NRTL listing of a finished product incorporating a laser module, and the NRTL is trying to bill you for doing a CDRH product report, well, they should not, since it is not a requirement for them to do so - ask which clause in the standard requires it. UL60950 clause 0.2 mentions lasers as a potential safety hazard, but the standard gives no detailed requirements. So really, what they're saying is correct - a letter of accession means nothing to a safety assessment.
The NRTL we've used generally requires a letter from us stating that a laser product report has been filed with CDRH. They also include the laser classification/warning label in the listing report. Also be aware that if you are incorporating a laser module into a finished product, it is your responsibility to submit product reports and annual reports to the CDRH, and you also have responsibilities for quality assurance, output power measurement in production, and record keeping. The module manufacturer actually has NONE of these responsibilities - CDRH requirements apply to finished products. Perhaps you have been the only unaccepting curmudgeon in the universe ;-) ! Others that incorporate the module into their products may routinely generate their CDRH product reports for the finished product, and the module vendor never hears that a letter of accession for the module is not sufficient to base assumption of conformity of the finished product on. Doug Massey Lead Regulatory Engineer LXE, Inc. -----Original Message----- From: Gary McInturff [mailto:gary.mcintu...@worldwidepackets.com] Sent: Tuesday, May 14, 2002 6:26 PM To: EMC-PSTC (E-mail) Subject: 2 questions. 1) HP software for 7400A analyzers, 2) FDA letters of Accession 1) I believe someone out there commented on using the HP 74XX series analyzer for pre-compliance measurements. Do you also use the additional software that can be purchased? The unit I played with had no additional software, but I could make measurements against limits lines etc, and it factored in the transceiver gains/losses and then allowed me to export a summary sheet for any reports I wanted to generate. What functions and value does the additional software bring to the table.? 2) Does anybody out there get any traction from a "Letters of accession" that the FDA sends to a optics vendor after receiving a request for a model addition? This letter says nothing useful for NRTL's and always includes "This acknowledgement does not constitute approval or the document". The FEDS are disavowing any level of conformity assessment, and the NRTL's I use tell me they can't use it, even for an unrecognized componet, yet the vendors are insistent that I am the only unaccepting curmudgeon in the entire universe. Sorry if you've heard this before but I just can't believe it keeps happening, and that tells me that I should double check my facts. Thanks Gary ------------------------------------------- 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" ------------------------------------------- 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"
