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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
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