Harnessing Social Needs Data to Advance Health Equity in Federally Qualified Health Centers

Abstract

Data Collection and Reporting Standards. The FDA Center for Devices and Radiological Health directs that clinical data be analyzed and reported by sex and gender. 2 Despite this mandate, there remains room to improve the quality and consistency of gender-and sex-specific data collection, analysis, and reporting. 1Regulatory Implementation and Oversight. The FDA has issued multiple guidelines on the inclusion of women throughout the last 20 years, yet clinical trial representation of women remains low. The time has come for the FDA to decline to review medical device (and drug) applications if the representation of women does not reflect the intended use population within a reasonable margin.