Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA, Agency, or we) is announcing a minor, technical modification to an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the "Voluntary Malfunction Summary Reporting Program."
Abstract as published in the Federal Register.
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