In May 2024, the U.S. Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). According to the FDA, the Final Guidance is designed to help medical device servicers understand when certain device... READ MORE
Remanufacturing or Servicing of Medical Devices: FDA Issues Final Guidance Providing Additional Clarification
Posted on June 21, 2024 in Health Law News
Published by: Hall Render
