The Food and Drug Administration (FDA) has released a draft guidance document titled "Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies." This document aims to promote the inclusion and analysis of sex- and gender-specific data in medical device studies to ensure safety and effectiveness. Historically, females and nonbinary individuals have been underrepresented in clinical trials, leading to inadequate information about medical devices for these groups. The guidance encourages sponsors to incorporate diverse data in clinical studies and reporting, but it is currently not final and the public is invited to submit comments until April 7, 2025.
Simple Explanation
The FDA wants people to check if medical devices are safe for everyone, including boys and girls, because in the past, they didn’t always test them on both. They have a new idea paper, but it's not ready yet, and they want thoughts from people to make it better by April 2025.