FDAnews Device Daily Bulletin

FDA Proposes Draft Guidelines Intended to Improve the Representation of Women in Medical Device Clinical Studies

Dec. 19, 2011
Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.