Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Remanufacturing of Medical Devices." This draft guidance is intended to help clarify whether activities performed on devices are likely "remanufacturing." This draft guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. This draft guidance is not final nor is it in effect at this time.