The Center for Devices and Radiological Health (CDRH) is sharing its Health of Women Program Strategic Plan, which lays out the framework to further the U.S. Food and Drug Administration’s (FDA) mission of protecting and promoting the health of women.

The plan also seeks to strengthen regulatory science and identify and address current and emerging issues in medical device research and regulation for the health of all women.

Scientists and the medical community are continuing to learn more about sex and gender differences. And, both, sex—which is 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.

The CDRH Health of Women program is 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, the Health of Women program intends to ensure all women have access to innovative, safe, and effective medical devices.

The CDRH Health of Women program was created in 2016 and since its start, the program has been working toward a better understanding of how medical devices—those developed specifically for women as well as those developed for people of all sexes and genders—perform in women and exploring unique issues in the regulation of medical devices related to the health of women.

Historically, biomedical research—from non-clinical cell research to animal studies to clinical human research—has overwhelmingly been conducted in patients assigned as male at birth. Representation in research is crucial to understand how medical products, including medical devices, interact with individuals of different sexes and genders. A lack of representation can have serious consequences for health outcomes for women.

With the knowledge that sex and gender differences factor into a person’s unique experience with medical devices and treatment outcomes, the CDRH Health of Women Program created its strategic plan in 2019. Since then, CDRH has considered that feedback, along with other lessons learned, to finalize the framework. The integrative, cross-cutting plan, which prioritizes the patient experience and leverages partnerships across CDRH, aims to establish a portfolio of women-specific device efforts and strategize around gap areas to inform our research.

The strategic plan lays out the program’s three main priorities:

  • Sex- and Gender-Specific Analysis & Reporting: Improve availability, analysis and communication of sex- and gender-specific information for the safe and effective use of medical devices to improve and better understand the performance of medical devices in women.
  • Integrated Approach for Current & Emerging Issues Related to the Health of Women: Strengthen internal health science programs and initiatives across CDRH, working together with CDRH offices and stakeholders, to create actions that aim to improve the overall health and quality of life for women.
  • Research Roadmap: Develop a guide for navigating the health of women medical device ecosystem.