I recently attended an SBIR/STTR conference organized by the NIH and one of the presenters was from the FDA's division of small manufacturers. He gave a great overview of the medical device regulations in one hour and referenced a relatively new and little-known series of videos on their website for training the public on the process of getting your new medical device idea legally to market. The videos start with the basic overview of the medical device regs (there is a similar set for your drug people out there) but continue on to cover some topics in detail, including device listing, facility registration, premarket clearance, the quality systems regulations (QSR or part 820) and even an overview of regulated software.
It's tough to actually find these training resources on the FDA website so here's the direct link:
http://www.fda.gov/Training/CDRHLearn/ucm162015.htm
The presenter's contact information:
Mr. Bill Sutton, Deputy Director, Division of Small Manufacturers, International and Consumer Assistance
Office of Communication, Education, and Radiation Programs
william.sutton@fda.hhs.gov
Main phone: 800-638-2041
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