New FDA Rules To Up Women In Medical Device Studies

Law360, New York (December 16, 2011, 7:24 PM EST) -- The U.S. Food and Drug Administration rolled out new guidelines Friday aimed at improving the historic underrepresentation of women in medical device clinical studies, the latest in a series of recent efforts to improve the development and review process for medical devices.

The FDA said the guidelines, currently in draft form, would help medical device developers and manufacturers design and conduct clinical studies that may enhance women's enrollment and address potential sex differences in the effectiveness of certain medical devices.

“Historically, women have been underrepresented in...
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