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20 November 2010


Dear Mr. Doyle,
Thank you for your comment. To be honest, I spent many hours looking for the origin of CDRH’s “mission” to foster medical device innovation. I found hundreds of references to it, including the one I finally used from CDRH’s website; but I could not find the original citation.

I went back to an original 1976 version of the Food, Drug and Cosmetic Act that I had laying around, I checked the current version of the Act and found the paragraph you quote in your comment, but I never did find an original citation for “foster medical device innovation”.

Your correction is welcome. And I wonder, do you have an idea of why so many people—FDA and the Working Group preliminary report people included—believe that fostering innovation is part of CDRH’s job description? How did this idea get started?

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