The U.S. Food and Drug Administration (FDA) has published a Final Guidance to clarify the meaning of “remanufacturing” of reusable medical devices that need either maintenance or repair.
According to the FDA, the Final Guidance, titled “Remanufacturing of Medical Devices: Guidance for Industry, Entities that Perform Services or Remanufacturing,” clarifies the specific types of activities that it classifies as “remanufacturing,” as well as its current requirements applicable to remanufacturers. The Guidance also includes recommendations for information to be included in device labeling to help ensure the quality, safety, and effectiveness of remanufactured devices over their anticipated useful life.
Medical devices intended for reuse play an integral part of healthcare, and include ventilators, endoscopes, and defibrillators. Proper servicing of such devices is essential in protecting the health and safety of patients and healthcare providers.
Read the FDA’s Final Guidance on the remanufacturing of medical devices.
