SWHR Feedback to FDA on Health of Women Strategic Plan

Policy Engagement

Published 12/23/19

In comments to the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), SWHR provided feedback on the strategic plan for the center’s Health of Women Program.

SWHR’s comments emphasized the need to prioritize the health of women within the realm of medical devices. Accounting for over half of the total U.S. population, women make up a significant portion of the market for health care products and medical devices. However, technology designed to improve and monitor women’s health has historically lagged far behind technology designed for men, and many of the devices on the market today were developed without recognition of the biological differences between women and men.

SWHR’s feedback focused on the following broad recommendations:

  • The need to highlight gaps in women’s health in the device space and identify ways in which CDRH can lead the scientific community in addressing these disparities.
  • The importance of including multiple stakeholders — most importantly, patients and patient advocates — within decision-making processes and steering committees.
  • Further clarification surrounding CDRH’s strategic partnerships and the goals of these partnerships.
  • Exploration of topics related to marketing, physician training, and patient education around medical devices, as these are key elements in promoting uptake of new devices or device redesigns.
  • Need for more information regarding CDRH plans for a portfolio of women-specific device efforts and a registry for women’s health devices, including how these projects will be created, where they will be housed, and who will be able to access them.
  • The importance of updating existing infrastructure to address data collection needs prior to creating new registries.

SWHR is appreciative of the release of the Health of Women Program strategic plan, as well as of CDRH’s efforts to incorporate stakeholder feedback. The Health of Women program’s focus on women’s health research within the world of medical devices is in line with SWHR’s overall mission to make women’s health mainstream.

Read SWHR’s Letter