In a July 9 Federal Register notice, the FDA published a new draft guidance on medical device reporting (MDR) for manufacturers. The draft updates the current version of the guidance with new information intended to help manufacturers determine whether, when, and how to report a malfunction in medical equipment. Although the guidance applies only to manufacturers, it includes a short appendix outlining the reporting responsibilities of user facilities, which it defines as “a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office.” The entire guidance may be found on FDA’s website.
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