FDA seeks comments on draft guidance for remanufacturing of medical devices by September 22, 2021


Per the FDA, the draft guidance is intended to help clarify whether activities performed on devices are likely "remanufacturing." Such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements. The draft guidance also provides recommendations for information that should be included in labeling to help assure the continued quality, safety and effectiveness of devices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.

ASHE strongly recommends organizations review the draft guidance and submit comments as this guidance does touch on the "right to repair" through its definitions and guidance. The guidance and online submission can be accessed on the FDA website.