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CDRH Health of Women Program

Read our CDRH Health of Women
Strategic Plan

 

The FDA’s Center for Devices and Radiological Health (CDRH) seeks public feedback on CDRH’s Health of Women Program’s new proposed Strategic Plan through a public docket in the Federal Register: FDA-2019-N-3804. The Strategic Plan outlines three CDRH Health of Women Program priorities that we are proposing.

The last day to submit comments to the docket is December 23, 2019. Your input will help shape how CDRH implements the program.

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What is CDRH’s 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, development, clinical trial design, and other medical device-related matters. Our program, formalized in 2016, extends beyond reproductive and gynecologic health. Our approach is comprehensive – it considers a woman’s entire body.

What makes CDRH’s 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 across a woman’s lifetime. Health of Women encompasses health conditions that are specific to women, as well as conditions that are more common or more serious in women, have distinct causes or manifestations in women, have different outcomes or treatment options in women, or have higher morbidity or mortality in women.

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

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 customers, including 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.

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

Providing women with access to the safest possible 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 women’s health 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.Health of Women News and Updates

Health of Women News and Updates

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