FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

The following quote is attributed to William Maisel, M.D., director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health

"Many medical devices are reusable and need preventative maintenance and repair during their useful life; therefore, proper servicing is critical to their continued safe and effective use. With this in mind, the FDA is issuing today’s draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices. It is important for industry personnel, such as original equipment manufacturers, servicers and remanufacturers, to have a clear understanding of activities that are considered remanufacturing so that they can apply appropriate statutory and regulatory requirements which exist to keep the American public safe."

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