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FDA In Brief: FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

The draft guidance should clarify “remanufacturing” and recommendations for labeling devices intended to be serviced over their useful life. A discussion paper outlining cybersecurity challenges and opportunities with the servicing was also released.

Original source: http://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-draft-guidance-remanufacturing-and-discussion-paper-seeking-feedback