This website uses cookies. For more information please contact us or consult our privacy policy.
Your binder contains too many pages, the maximum is 40.
We are unable to add this page to your binder, please try again later.
This page has been added to your binder.
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, ...
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FDA Issues Draft Guidance on Evaluating Substantial Equivalence in 510(k) Premarket Notifications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