Medical device reporting--FDA. Reproposal

The Food and Drug Administration (FDA) is issuing a revised proposal to require manufacturers and importers of medical devices to report to FDA whenever the manufacturer or importer has information that reasonably suggests, or a person alleges and the manufacturer or importer is aware of the allegation, that a device has caused or contributed to a death or serious injury or that a device has malfunctioned, if a recurrence of the malfunction is likely to cause or contribute to a death or serious injury. After FDA analyzes the results of its manufacturer complaint file inspection program, the agency will consider whether any reports in addition to those proposed in this rule are necessary and, if so, will propose additional reporting requirements.