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FDA Proposes UDI System for Medical Devices
August 2012, Journal of Medical Device Regulation
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supersedes the Medical Device Reporting for Manufacturers final guidance published in March 1997, and replaces FDA’s draft guidance on Medical Device Reporting for Manufacturers (“Draft Guidance”) published on July 9, 2013. Following the release of the Draft Guidance, FDA received 33 comments from various stakeholders.
FDA Issues Proposed Rule to Establish a Unique Device Identification System for Medical Devices
July 16, 2012, Covington Advisory
FDA Issues Draft Guidance on Evaluating Substantial Equivalence in 510(k) Premarket Notifications
February 7, 2012, Covington E-Alert