
Written By Courtney A. Stevens | Staff Attorney, Medmarc Loss Control
On July 9, the FDA issued a new draft guidance document addressing device manufacturers’ responsibility to report adverse events: “Medical Device Reporting for Manufacturers.” The guidance is intended to replace the 1988 and 1997 MDR guidances, and includes several clarifications and additions aimed at providing manufacturers with a clearer and better-defined framework for understanding their reporting obligations.
The draft guidance is consistent with previous versions in defining “MDR reportable events” as “events that manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur…