FDA Issues Draft Guidance for Improving Representation of Women in Device Studies

December 16, 2011—The US Food and Drug Administration announced that it has issued draft guidance aimed to address the historic underrepresentation of women in clinical studies. The guidance is intended for medical device developers and manufacturers. In the document, the FDA outlines its recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

The FDA advised that it is seeking input on this draft guidance during a 90-day public comment period. The draft guidance can be accessed on the FDA Web site.

Jeffrey Shuren, MD, the Director of the FDA's Center for Devices and Radiological Health, commented, “The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies. Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices.”

The FDA noted that certain medical products may elicit different responses in women than in men. This may be due in part to basic differences in men and women, including genetics, hormones, body size, diet, and sociocultural issues. In addition, certain variables associated with women, such as size or certain illnesses, may be responsible for certain differences between men and women in the safety and effectiveness of medical devices.

According to the FDA, a 2001 report by the US Government Accountability Office on FDA-reviewed drug studies found that although women represented 52% of study enrollees, 30% of study documents did not report outcomes by sex, and nearly 40% did not report enrollment demographics. A 2009 study of cardiovascular device premarket approval applications showed that pivotal studies that reported sex enrolled an average of 33.9% women.

The draft guidance addresses study and evaluation of sex differences, data analysis, and reporting in both pre- and postmarket device clinical studies. In addition, it covers issues regarding statistical analyses of sex differences and how to report sex-specific information in summaries and labeling for approved devices. Devices intended for single-sex use, of course, would not be expected to address potential sex differences, stated the FDA.