Medical Device Reporting for Manufacturers; Final Guidance

Medical Device Reporting for Manufacturers; Final Guidance

December 6, 2016, Covington Alert

On November 8, 2016, the U.S. Food and Drug Administration (FDA) published a final guidance titled Medical Device Reporting for Manufacturers (“Final Guidance”). The guidance explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. On November 30, 2016, FDA explained its reasoning behind certain provisions in the Final Guidance through a webinar. The Final Guidance supersedes the Medical Device Reporting for Manufacturers final guidance published in March 1997, and replaces FDA’s draft guidance on Medical Device Reporting for Manufacturers (“Draft Guidance”) published on July 9, 2013. Following the release of the Draft Guidance, FDA received 33 comments from various stakeholders.