FDA Releases CDRH Women’s Health Strategic Plan to Better Inform Medical Device Research and Regulation for All Women


SILVER SPRING, MD., January 18, 2022 /PRNewswire/ — Today, as part of the United States Food and Drug Administration’s ongoing commitment to protect and promote the health of all women, the Center for Devices and Radiological Health (CDRH) shares its strategic plan for the Health of Women program. CDRH initially published a draft strategic plan in September 2019 and considered public input to inform this strategic plan, which sets the framework for advancing FDA’s mission by protecting and promoting women’s health, strengthening regulatory science, and identifying and addressing issues. current and emerging issues in the research and regulation of medical devices for the health of all women.

As scientists and the medical community continue to learn more about sex and gender differences, we are learning that sex – the biological characteristics of an individual – and gender – the social construct by which one can define oneself. – can play an important role in the course and outcome of conditions that affect all human organ systems. Although sex and gender are interdependent, they are not necessarily mutually exclusive, and their interactions can affect physiological responses, disease presentation, and treatment outcomes.

Now more than ever, we need to understand the implications of sex and gender on the performance of medical devices in all individuals. The CDRH Health of Women program is a comprehensive, collaborative, and landmark program founded on the principle that sex and gender have a profound impact on a woman’s overall health, not just her reproductive or sexual health. With patients at the heart of this initiative, and with the strategic plan as the model for the center’s priorities, Health of Women aims to ensure that all women have access to innovative, safe and effective medical devices.

The CDRH Women’s Health Program

The CDRH Health of Women program was created in 2016 to respond to the growing importance of sex and gender-specific issues arising from the design and development of medical technologies, the design of clinical trials and other related issues. to medical devices. Since its launch, the program has worked to better understand how medical devices – those developed specifically for women as well as those developed for people of all sexes and genders – work in women and explore the unique issues of regulating medical devices related to women’s health.

Historically, biomedical research – from non-clinical research on cells to animal studies to clinical research on humans – has been overwhelmingly conducted in patients designated as male at birth. Representation in research is crucial to understanding how medical products, including medical devices, interact with individuals of different sexes and genders. A lack of representation can have serious consequences for women’s health. An example of this is cardiovascular devices like pacemakers which can have different outcomes and complication rates in men and women. This is just one case where sex and gender make a difference in the design of a clinical study that will provide optimal results in terms of safety and efficacy for all patients.

CDRH Strategic Plan for Women’s Health

Knowing that sex and gender differences impact a person’s unique experience with medical devices and treatment outcomes, the CDRH Health of Women program created its strategic plan in 2019. At that time, the FDA solicited comments from the public and other stakeholders on the content of the regime. Since then, the CDRH has considered these comments, along with other lessons learned, to finalize the framework. The integrative and cross-cutting plan, which prioritizes patient experience and leverages partnerships within CDRH, aims to establish a portfolio of women-specific device efforts and strategize around gaps to inform our research.

The strategic plan sets out the program’s three main priorities:

  • Sex and gender specific analysis and reporting— Improve the availability, analysis and communication of sex and gender-specific information for the safe and effective use of medical devices in order to improve and better understand the performance of medical devices in women; optimize CDRH practices for consistent gender and gender data collection, analysis and reporting; ensure that CDRH policies evolve with current science.
  • Integrated approach to current and emerging women’s health issues— Strengthen internal health science programs and initiatives across CDRH, in collaboration with CDRH offices and our stakeholders, to create actions to improve the overall health and quality of life of women; coordinate and lead an integrated approach to analyzing current and emerging issues related to women’s health; explore innovative strategies, technologies, and device-specific study paradigms; develop centre-wide policies and advocacy related to women’s health.
  • Research roadmap—Develop a guide for navigating the medical device ecosystem for women’s health; address identified gaps and unmet needs related to women’s health with targeted resources; promote the advancement of regulatory science related to women’s health.

With the implementation of these three strategic priorities, we aim to deepen our understanding of how medical devices work for women and continue our efforts to help ensure that medical devices – those developed specifically for women and those developed for all – optimally align with usability and performance considerations in women. In this way, we hope to achieve the highest quality of innovation, safety and effectiveness for every patient.

Additional Resources:

Media Contact: Abby Capobianco, 240-461-9059
Consumer requests: Email or 888-INFO-FDA

The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.

SOURCE US Food and Drug Administration


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