On January 18, 2022, the FDA's Center for Devices and Radiological Health (CDRH) released its Health of Women Program 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."
Coming in the wake of a study finding that women whose operations were performed by a male surgeon had a 32 percent higher risk of death post-surgery than those who were operated on by a woman, CDRH's initiative is designed "to understand the implications sex and gender present for the performance of medical devices in all individuals."
The Strategic Plan has three 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; optimize CDRH practices for consistent sex- and gender-specific data collection, analysis and reporting; ensure CDRH’s policies evolve with current science."
- "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 our stakeholders, to create actions that aim to improve the overall health and quality of life for women; coordinate and lead an integrated approach to analyze current and emerging issues related to the health of women; explore innovative strategies, technologies and device-specific study paradigms; develop center-wide policies and outreach activities related to the health of women."
- "Research Roadmap—Develop a guide for navigating the health of women medical device ecosystem; address identified gaps and unmet needs related to the health of women through targeted resources; promote advancement of regulatory science related to the health of women."
According to a statement issued by Terri Cornelison, M.D., Ph.D., Chief Medical Officer and Director, Health of Women Program at CDRH:
"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. An example of this is cardiovascular devices like pacemakers that may have different outcomes and complication rates in men and women. This is just one instance of when sex and gender make a difference in designing a clinical study that will provide optimal results for safety and effectiveness for all patients."
CDRH's implementation of the Strategic Plan will undoubtedly have significant implications for medical device manufacturers and healthcare providers.