On This Page:

• What is the CDRH Health of Women Program?
• What are the goals of the CDRH Health of Women Program?
• Contact Us
• Additional Health Information for Women

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What is the CDRH Health of Women Program?

CDRH has been working towards a better understanding of how medical devices perform in women and exploring unique issues in the regulation of medical devices related to the health of women.

The CDRH Health of Women Program recognizes the importance of addressing sex- and gender-specific issues in medical technology design and development, clinical and non-clinical study design, and other medical device-related matters. Our comprehensive program, formalized in 2016, extends beyond reproductive and gynecologic health and considers a woman's entire body.

What makes the CDRH Health of Women Program unique is that we envision a groundbreaking, modern program to explore the unique issues related to the performance of medical devices in women, not only during their reproductive years, but across a woman's lifetime. The program encompasses medical devices for health conditions that are specific to women, as well as conditions that are more common in women, have distinct causes or manifestations in women, have different outcomes or treatment options in women, or have higher morbidity or mortality rates in women.

The CDRH Health of Women Program helps support the FDA Office of Women's Health through the foundational principle that sex and gender should be factored into research design, analysis, reporting, and education.

The CDRH Health of Women Program collaborates with federal partners in the medical device ecosystem, including offices of women’s health across the U.S. Department of Health and Human Services, in furthering its mission to protect and promote the health of women, to strengthen regulatory science, and more easily identify and address current and emerging issues.

Mission

The mission of the CDRH Health of Women Program is to protect and promote the health of all women.

Vision

Our vision is that patients, caregivers, and providers have timely access to high quality, safe, and effective medical devices that perform optimally in women, as well as access to relevant and understandable sex- and gender-specific information about medical devices that can be used to make informed health care decisions.

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What are the goals of the CDRH Health of Women Program?

Providing women with access to high quality, safe, and effective medical devices on the market to meet their health care needs is a top priority for CDRH.

The CDRH Health of Women Program will explore unique issues related to the performance of medical devices in women, improve analysis and communication of sex- and gender-specific data to better assure the safe and effective use of medical devices, and develop and implement health science programs, strategies, and initiatives focused on health of women issues across CDRH. In these ways, we will continue to work to assure that medical devices are innovated to perform safely, effectively, and optimally in all women.

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Contact Us

• Send your questions about CDRH's Health of Women Program to CDRHHealthofWomen@fda.hhs.gov
• Follow us on Twitter: @FDADeviceInfo #HealthofWomen

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Additional Health Information for Women

• FDA Voices "The FDA's Critical Focus on Women's Health"
• 2019 Health of Women Strategic Plan
• Read about other women's health information
• Read the latest safety news about medical devices
• Read information about regulated medical devices
• Learn about women's health research opportunities