Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
Primary source
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Issuing agencies
Abstract
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."
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