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 [email protected] | 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 |
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