RE: 2 questions. 1) HP software for 7400A analyzers, 2) FDA letters of Accession
Hi Gary, >From your message: 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 We have seen the same situation. The FDA usually provides us an accession letter. Which essentially says that they've received our CDRH Laser Device submittal and they'll get back to us with a "review letter" if they see any problems. We almost NEVER see the review letter; and we have probably hundreds of different models submitted to the FDA. Furthermore, the FDA does not feel obligated to provide the review letter. As a practical matter, they have limited staff; so they concentrate their efforts on laser light shows, medical lasers and high power lasers that can really do some damage. They hardly have time for our little class one OTDR lasers. According to John Juhasz, whom I have talked to on this subject, they may provide the review letter if you harass them a little bit. So we are in the same catch-22. The FDA might not provide the review letter; and the NRTL might not accept the accession letter. If you can't get the review letter, third party testing of your laser device is an option. Or perhaps, you could get the NRTL to audit your own in-house testing (this is strictly hypothetical). I can share with you some particulars such as names, test cost and other gory details if you want to contact me offline. Hope this helps. Chris Maxwell | Design Engineer - Optical Division email chris.maxw...@nettest.com | dir +1 315 266 5128 | fax +1 315 797 8024 NetTest | 6 Rhoads Drive, Utica, NY 13502 | USA web www.nettest.com | tel +1 315 797 4449 | --- 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"
RE: 2 questions. 1) HP software for 7400A analyzers, 2) FDA letters of Accession
Doug, and Scott, Thanks for the input. I guess I should learn to rant and rave with clarity. You both are correct but I should have pointed out that 1) these are self contained laser optics modules, and 2) I should have said the letter of accession without the CDRH or test data acceptable to UL. I agree with the position the NRTL takes without having any data in front of them that supports the manufacturers claims of eye safeness. Some of these things even have class II lasers, but are internally constructed so that they can only output class I levels. So as a NRTL I certainly would want to have some verification. other than just a letter than basically says we received some information from and we'll let you know. I have explained more times than I care to remember, that I will even take the unrecognized component route if they will simply provide UL (yeah I guessed from the clues Scott), with a copy of the CDRH and the letter. The information contained in the CDRH stays proprietary to the laser vendor because it goes direct to UL and not me. They release no information to me, just review the document for their needs and accept the module for use in my equipment. If I'm the only guy buying their modules they are done, if not they are going to have to keep repeating this process but that is their worry not mine. The only exception to the case is where I have an "array" of these modules sticking out the front of the box. Then I worry about the flammability of the parts as well. Look at the front of medium and large switches and routers you'll be impressed by the number of these things bridging the enclosure inside to out. I have even spent a 1/2 hour or so with one of the district sales guys for one of these companies reviewing all of the requirements, how the NRTL's investigate and verify components, and why. He charged out here all set to go. 6 months later still no progress and I disqualified the company. Basically, we don't even look at this vendor for new parts. They check in with the component guys every so often and the first question is have you completed the necessary steps to provide proof of certification acceptable to the NRTL. The conversations is generally halted about that time. So if you provided both, the letter and the CDRH test data I can be happy, but not just the letter by itself. I just keep seeing that fool letter stand alone. 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"
