SWHR Comments to FDA on MDUFA Reauthorization for Fiscal Years 2023-2027

The Society for Women’s Health Research (SWHR) submitted comments as a follow-up to the U.S. Food and Drug Administration (FDA) public meeting regarding the proposed recommendations for the reauthorization of the Medical Device User Feed Act (MDUFA) for fiscal years (FYs) 2023 through 2027. In advance of MDUFA’s expiration in September 2022, SWHR offered the following recommendations that represent priorities for the millions of women nationally who rely on medical devices.

1. Incorporate commitments to the Center for Devices and Radiological Health’s (CDRH) Health of Women Program.
2. Continue work to prioritize diversity within clinical trials as related to sex, gender, race/ethnicity, age, and other important demographic variables.
3. Apply lessons learned from the COVID-19 pandemic to strengthen the agency’s approach to decentralizing clinical trials and make research participation more available to an increasingly diverse range of patients.
4. Coordinate the FDA approach to digital health technologies in order to expand patient access to care while maintaining safety and privacy.
5. Address concerns regarding the possibility of bias within artificial intelligence (AI) and machine learning technology.
6. Better integrate real-world evidence (RWE) within device approval and decision-making initiatives.
7. Consider the needs of pregnant individuals within clinical device trials.

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