The FDA’s Strategic Plan for Women’s Health

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:

• Sex- and gender-specific analysis & reporting – Improve the availability and analysis of this information to improve the understanding and increase clarity on the performance of medical devices in women.
• Integrated approach for current & emerging issues related to the health of women – Integrating the approach to women’s health will foster early identification and communication of adverse effects women could face, leading to maximized innovation and safety.
• Research roadmap – Creating a research roadmap will help identify gaps, foster development, and support women’s device registries. As access to information becomes more readily available, medical device manufacturers will be able to include both males and females in the testing of their devices to ensure accurate analysis and reporting.

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.