FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women

Food and Drug Administration

WASHINGTON, D.C. — This week, the U.S. Food and Drug Administration, through the Center for Devices and Radiological Health (CDRH), shared the Health of Women Program Strategic Plan. CDRH initially issued a proposed strategic plan in September 2019 and has considered public feedback to inform this strategic plan, which lays out the framework to further the FDA’s mission by protecting and promoting the health of women, strengthening regulatory science, and identifying and addressing current and emerging issues in medical device research and regulation for the health of all women.

As scientists and the medical community continue to learn more about sex and gender differences, we are learning that both sex—an individual’s biological characteristics—and gender—the social construct by which one may define oneself —may play significant roles in the course and outcome of conditions that affect all human organ systems. While sex and gender are interrelated, they are not necessarily mutually exclusive, and their interactions may affect physiological reactions, presentation of disease and treatment outcomes.

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Now more than ever, we need to understand the implications sex and gender present for the performance of medical devices in all individuals. The CDRH Health of Women program is a comprehensive, collaborative, landmark program built on the premise that both sex and gender have a considerable impact on a woman’s overall health, not just their reproductive or sexual health. With patients at the heart of this initiative, and with the strategic plan as a blueprint for the center’s priorities, Health of Women intends to ensure all women have access to innovative, safe and effective medical devices.

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