U.S./EU DEVICE MRA TO INCLUDE 42 CLASS II DEVICES INITIALLY; GOVERNMENTS BEGIN YEAR-LONG RATIFICATION PROCESS FOLLOWING "AGREEMENT IN PRINCIPLE"
This article was originally published in The Gray Sheet
Executive Summary
A U.S./EU device mutual recognition agreement will include 42 Class II products upon implementation of the pact's three-year transition period, a senior FDA official said during a June 3 teleconference.