U.S./EU MRA
This article was originally published in The Gray Sheet
Executive Summary
Office of Management and Budget reports in the Aug. 4 Federal Register that it has signed off on the medical device third-party review program included in the U.S./European Union mutual recognition agreement. On July 2, FDA had requested "emergency processing" of the third-party provision by OMB so that candidate certified assessment bodies could be designated in time to join training programs for premarket and quality system evaluations slated for Oct. 14-23