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- FCC Takes Steps to Make More Spectrum Available for Wireless Medical Devices
FCC Takes Steps to Make More Spectrum Available for Wireless Medical Devices
June 7, 2012, Covington Advisory
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, ...
April 30, 2014, Covington E-Alert
FDA Issues Proposed Rule to Establish a Unique Device Identification System for Medical Devices
July 16, 2012, Covington Advisory