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# CDRH Health of Women Program Strategic Plan
- URL: https://www.fdaweb.com/cdrh-health-of-women-program-strategic-plan/
- Published: 2019-09-23T12:00:00.000Z
- Updated: 2026-09-15T01:51:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145065

CDRH is seeking comments on its just-released “Health of Women Program Strategic Plan” that aims to “explore the unique issues related to the performance of medical devices in women, not only in the reproductive health space, but across a woman’s lifetime.” The plan focuses on three priority areas: 

- Sex- and gender-specific analysis and reporting
- Integrated approach for current and emerging issues
- Research roadmap

Under the first priority, CDRH says it wants to improve availability, analysis, and communication of sex- and gender-specific information for devices used in women. To accomplish this, it says it will optimize CDRH practices for consistent sex- and gender-specific data collection, analysis, and reporting. It should also ensure CDRH’s policies evolve with current science, the plan says.

The plan also aims to strengthen internal women-related health science programs and initiatives across CDRH through an integrated approach that analyzes current and emerging issues. In addition, it will explore innovative strategies, technologies, and device-specific study paradigms, the plan says, adding that Center-wide policies and outreach activities related to the health of women will be developed.

The last priority will have CDRH developing a research roadmap for the health of women device ecosystem, the plan says. It should address identified gaps and unmet needs through targeted resources, and promote advancement of regulatory science related to womens’ health.