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FDA Draft Guidance on Evaluation of Sex Differences in Medical Device Clinical Studies

  • By: www.fda.gov
  • Date: December 29, 2011
Abstract:

The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials. Aimed at medical device manufacturers and developers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

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