FDA Addresses Sex Disparity in Device Trials

By: MARK S. LESNEY, Cardiology News Digital Network: 03/16/12.

Medical device studies have shown persistent underrepresentation of women – a sex gap that could have a profound impact on the health of women who receive such devices.

In an attempt to correct this disparity, the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued draft guidance in December 2011 outlining the center’s expectations regarding sex-specific patient enrollment, data analysis, and reporting.

The goal of the guidance is to improve the quality and consistency of data on the performance of medical devices in both sexes, in particular addressing the underrepresentation of women in such studies. When the document is finalized after a 90-day comment period ending in March, it will represent the FDA’s current thinking on the topic. Read More