FDA Releases Device Guidance Strategies For Women

The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has released a strategic plan aimed at improving the health and safety of women in America. In their statement, the FDA described the “need to understand the implications sex and gender present for the performance of medical devices in all individuals.”

According to the FDA, the CDRH Health of Women program is “a comprehensive, collaborative, landmark program 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.”

This program, conceived in 2016, developed its first proposed strategic plan three years ago in 2019. Since then, it has been incorporating public feedback that it received to create a strategic blueprint “with patients at the heart.”

The plan has three main prongs: Sex- and Gender-Specific Analysis & Reporting, Integrated Approaches for Current & Emerging Issues Related to the Health of Women, and a Research Roadmap. These prongs will help address the historic fact that “biomedical research… has overwhelmingly been conducted in patients assigned as male at birth.”

The FDA believes that addressing this disparity and increasing representation “is crucial to understand how medical products, including medical devices, interact with individuals of different sexes and genders,” resulting in medical devices that are safer for people of all sexes and genders.

Sex- and Gender-Specific Analysis & Reporting

By increasing the availability, analysis and communication of sex- and gender-specific information for the safe and effective use of medical devices, the CDRH believes that they will better understand how certain medical devices affect women. This prong also prioritizes the optimization of CDRH practices of data collection and policies to stay up-to-date with the current scientific consensus.

Integrated Approaches for Current & Emerging Issues Related to the Health of Women

By taking an integrated approach for current and emerging issues with women’s health, the CDRH can explore innovative strategies, technologies and device-specific studies and develop organization-wide policies and outreach efforts to better address the health of women. These policies will aim to improve the health and quality of life for women based on the problems that they say they are facing in their daily lives.

Research Roadmap

Finally, by developing a research roadmap, the CDRH can publicly demonstrate what steps are being taken by providing an intended guide for navigating the health of women in the medical device ecosystem. This roadmap demonstrates how the CDRH plans to address identified gaps and unmet needs related to women and how the CDRH will target its resources to promote the advancement of regulatory science related to the health of women.

According to the National Institutes of Health Office of Research on Women’s Health, women have historically been excluded from clinical trials and scientific studies. This has “led to a shortage of data on how drugs affect women,” according to the NIH.

In 1993, Congress passed the NIH Revitalization Act of 1993 with a subsection titled, “Women and Minorities as Subjects in Clinical Research” to increase women’s representation in studies and clinical trials. This FDA plan continues government efforts to understand and include women’s bodies in the study of new medical devices.

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