FDA Issues CDRH Health of Women Strategic Plan

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently issued its Health of Women Strategic Plan. CDRH released a proposed strategic plan in September 2019 and has since considered public feedback to the plan, which lays out a framework to protect/promote the health of women, strengthen regulatory science, and identify/address current and emerging issues in medical device research and regulation.
 
The CDRH Health of Women program is a comprehensive, collaborative program created in 2016 built on the premise that both sex and gender have significant impact on a woman’s overall health, not just reproductive or sexual health. It addresses sex- and gender-specific issues of medical technology design and development, clinical trial design, and other device-related matters.
 
Historically, biomedical research was overwhelmingly conducted in patients assigned male at birth. A lack of representation can have serious consequences for women’s health outcomes. For example, pacemakers might have different outcomes and complication rates in men and women.
 
The CDRH Health of Women program created its strategic plan in 2019. The FDA sought input from the public and other stakeholders on the plan’s content, and since then has considered the feedback to finalize the framework. It aims to establish a portfolio of woman-specific device efforts and strategize around gap areas to inform research.
 
The plan outlines the program’s three main priorities:
 
Sex-and Gender-Specific Analysis and Reporting
This aims to improve availability, analysis, and communication of sex- and gender-specific info for safe and effective medical device use. CDRH practices will also be optimized for consistent sex- and gender-specific data collection, analysis, and reporting. It will also ensure CDRH policies evolve with current science.
 
Integrated Approach for Current and Emerging Issues Related to the Health of Women
Internal health science programs will be strengthened to create actions aiming to improve women’s overall health and quality of life. A coordinated, integrated approach will analyze current and emerging issues related to women’s health. Innovative strategies, technologies, and device-specific study paradigms will be explored. Center-wide policies and outreach activities will also be developed.
 
Research Roadmap
A guide to navigate the women’s health medical device ecosystem will be developed. Identified gaps and unmet needs related to women’s health will be addressed through targeted resources. Regulatory science advancement related to women’s health will also be promoted.