Bloomberg Law
Free Newsletter Sign Up
Login
BROWSE
Bloomberg Law
Welcome
Login
Advanced Search Go
Free Newsletter Sign Up

Women’s Health Data Gets Focus in FDA Device Research Initiative

Jan. 18, 2022, 8:50 PM

Improving the use of gender-specific data in medical device research will get a fresh focus under an FDA initiative aimed at boosting women’s health.

A strategic plan published Tuesday by the Food and Drug Administration’s Center for Devices and Radiological Health lays out ways to better assess whether and how certain device designs perform differently among women and men. The goals of the plan include accounting for sex and gender in data collection, developing center-wide policies for women’s health research, and addressing existing gaps in medical device studies.

The document is part of the CDRH Health of Women Program’s mission ...