Business · 07/01/2025Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance on Sex-Specific Data in Medical Device Clinical Studies
Summary
The FDA has released a draft guidance document to encourage the consideration of sex and/or gender in medical device clinical studies, aiming to improve the safety and effectiveness of devices.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →