CDRH outlines plan to understand sex and gender differences in medical devices

Regulatory NewsRegulatory News | 21 January 2022 |  By 

The US Food and Drug Administration (FDA) has finalized its strategic plan for incorporating sex and gender differences into the development and regulation of medical devices.

The Health of Women Program Strategic Plan, released on 18 January 2022, outlines priorities for integrating the health of women into the research and regulatory work of FDA’s Center for Devices and Radiological Health (CDRH). The strategic plan finalizes a proposal released in September 2019.

“Now more than ever, we need to understand the implications sex and gender present for the performance of medical devices in all individuals. 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 women’s overall health, not just their reproductive or sexual health,” Terri Cornelison, MD, PhD, chief medical office and director of the Health of Women Program at CDRH, said in a statement.
The CDRH Health of Women Program was created in 2016 with the aim of understanding how medical devices perform in women and the unique regulatory issues related to women’s health. The finalized strategic plan sets out a portfolio of women-specific device efforts and strategies to close research gaps. The three main priorities of the plan are to:

  • Improve sex- and gender-specific analysis and data reporting
  • Create an integrated approach to current and emerging issues on women’s health
  • Develop a research roadmap related to the health of women
Sex- and gender-specific data

The agency’s goal is to use this data in premarket submissions and postmarket surveillance, according the CDRH strategic plan.

The agency intends to take a “least burdensome” approach to medical device premarket evaluation, as required by the FDA Modernization Act of 1997 (FDAMA). Developers and researchers are not being asked to generate more data, according to the report, but to analyze and report on data that has already been generated. 

CDRH also plans to develop recommendations related to non-clinical studies for sex- and age-subgroup analysis.

“We aim to refine current, and develop new, policies and recommendations to help innovators and researchers consider the potential influence of sex- and gender-specific data and address these factors in the experimental design, analysis, and reporting of medical device biomedical research,” CDRH officials wrote in the strategic plan. “Our hope is that this may lead to a stronger foundation upon which to develop devices and better inform the research community as to whether such influences need to be factored into the design and power calculations of future studies.”

Integrated approach

The strategic plan also tackles ways to integrate women’s health into scientific and regulatory initiatives across CDRH. One goal is to improve processes for the early identification of adverse effects of medical devices on women.

The plan calls for forming two internal groups: the Health of Women Steering Committee would provide recommendations to CDRH, and the Health of Women Core Community of Practice would coordinate existing subject matter expertise within the Center.
CDRH officials also plan to collaborate with outside partners to figure out how to incorporate findings of sex and gender differences into the design and application of new medical device technologies.

“We hope to help foster innovative technologies that may address sex- and gender-based differences via alternative means, including novel animal, in vitro, and computational models to study sex differences; information systems used for collecting, sharing, and comparing clinical data; and sex- and gender-conscious engineering design and development of medical devices,” according to the strategic plan.

Research roadmap

As part of the research roadmap, CDRH officials plan to establish a portfolio of women-specific research projects, develop an initiative on the science of patient input, and work with outside groups and developers to build registries of women’s devices and to run sex- and gender-specific analyses within existing registries developed for use in both men and women.

CDRH: Health of Women Strategic Plan


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you