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Subject:Looking for information re FDA submissions From:Win Day <winday -at- home -dot- com> To:"TECHWR-L" <techwr-l -at- lists -dot- raycomm -dot- com> Date:Tue, 14 Dec 1999 12:35:01 -0500
Has anyone here ever written an FDA submission for a medical device?
I interviewed yesterday for a contract involving writing the FDA submission
documents for a DNA sequencer. I know nothing about FDA submissions; the
company doesn't either. This is their first one, and they're betting the
farm on this product. They did get some general guidelines from the FDA,
but nothing resembling a sample submission.
I'm hesitant to take on a contract where the client doesn't really know
what needs to be included, and to what level of detail. And it's so
important that they get it right the first time!
If anyone has any experience in this area, would you please contact me
off-list?
