Business · 19/02/2019Updated: 10/17/2026 · 1 min read

FDA Releases Final Guidance on Evaluation of Devices Used with Regenerative Medicine Advanced Therapies

The US Food and Drug Administration (FDA) has published a final guidance document outlining its approach to evaluating devices used in regenerative medicine therapies, aiming to simplify and streamline regulatory requirements for combination devices and cell or tissue products.