May 8th – 14th, 2022, is National Women’s Health Week, and the FDA is taking strategic steps to promote women’s health and safety through the research and development of medical devices. The FDA’s Center for Devices and Radiological Health (CDRH) recently released its Health of Women Strategic Plan. While it is widely accepted in the scientific community that different biological sexes have unique responses to disease, medications, therapies, and medical devices, the CDRH finds that male subjects have historically been the primary focus of biomedical research. In fact, for diseases more prevalent in females, studies show that only 12% of biomedical research is focused on female subjects.
The CDRH believes the lack of female subjects could mean incomplete data in research. With the objective to promote women’s health, strengthen regulatory science, and address current and emerging issues in medical device research, they have identified the following key priorities to bridge research gaps:
Integrating biological sex and gender identity into understanding diseases, risk assessments, proper testing, and effective treatments will allow the scientific community to continue to evolve and enhance women’s health practices. For more information on the CDRH’s commitment to improving the health of women, click here. To learn more about National Women’s Health Week, click here.