FDA Issues Draft Guidance for Increasing Women Representation in Medical Device Clinical Trials

• By: Staff Editor
• Date: December 28, 2011

The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials.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.

This article gives an overview and summary of recommendations included in this FDA draft guidance.