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20 November 2010


Bob Doyle

It is: The Center for Devices and Radiological Health (CDRH), part of the U.S. Food and Drug Administration (FDA), helps ensure that medical devices are safe and effective as authorized by the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, helps reduce unnecessary exposure to radiation from medical, occupational, and consumer products as authorized by the Radiation Control for Health and Safety Act of 1968, and assures the quality of mammography as authorized by the Mammography Quality Standards Act of 1992.

Nancy J Stark

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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