FDA launches plan to improve how medical devices perform for women

Jan. 20, 2022

The U.S. Food and Drug Administration (FDA) has launched a strategic plan to identify and address women’s health in medical device research and regulation.

“As scientists and the medical community continue to learn more about sex and gender differences, we are learning that both sex — an individual’s biological characteristics — and gender — the social construct by which one may define oneself — may play significant roles in the course and outcome of conditions that affect all human organ systems. While sex and gender are interrelated, they are not necessarily mutually exclusive, and their interactions may affect physiological reactions, presentation of disease and treatment outcomes,” the FDA said.

The women’s health program, originally created in 2016, is designed to address that fact that “biomedical research has overwhelmingly been conducted in patients assigned as male at birth,” the FDA said.

The FDA sought input from the public about the strategic plan, which the agency drafted in 2019, before finalizing it.

The program and strategic plan are managed by the Center for Devices and Radiological Health (CDRH), which plans to establish a portfolio of women-specific device development and research efforts.

The plan has three main objectives:

  • Improve the availability, analysis, and communication of sex- and gender-specific information on medical devices and improve and understand the performance of medical devices in women
  • Strengthen science programs throughout CDRH, with an aim of improving the overall health and quality of life for women
  • Create a research roadmap to navigate the medical device landscape in light of women’s health

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