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FDA Issues Draft Guidance on Remanufacturing

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Yesterday, the FDA published its draft guidance Remanufacturing of Medical Devices to help clarify whether activities performed on devices are likely remanufacturing. The draft guidance includes recommendations as well concerning information that should be included in labeling to help assure the continued quality, safety and effectiveness of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. Previously, the FDA considered information learned from the agency’s activities discussed in this draft guidance, including a 2016 public workshop and docket for public comment and a 2018 FDA-authored white paper, public docket and public workshop on the topic. The FDA will begin accepting comments from the public on the draft guidance today and will host an upcoming webinar to allow industry to ask questions of the agency’s subject matter experts on this topic.