U.S./EU DEVICE MRA AGREEMENT IN PRINCIPLE SETS JAN. 31 DEADLINE FOR PACT;FDA TO OPPOSE INCLUSION OF PRODUCT APPROVALS AT TALKS IN BRUSSELS
This article was originally published in The Gray Sheet
Executive Summary
FDA's opposition to the inclusion of product approvals in a device mutual recognition agreement with Europe for likely will be the focus of discussion at a U.S. government/industry meeting planned for the next few weeks. Industry and government reps from FDA, the Department of Commerce and the U.S. Trade Representative's office are meeting to discuss the U.S. position on a device MRA in preparation for January U.S./European Union trade talks in Brussels.