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U.S./EUROPEAN MUTUAL RECOGNITION TALKS FOR DEVICE APPROVALS ON HOLD UNTIL 1997 AT EARLIEST WHILE AGENCY EVALUATES THIRD-PARTY REVIEW PILOT PROGRAM

This article was originally published in The Gray Sheet

Executive Summary

Medical device mutual recognition agreement negotiations between FDA and the European Union are on hold until 1997 at the earliest, according to FDAers and U.S. trade officials. Talks were delayed after FDA topsiders rejected a draft "concept paper" outlining a device approval MRA strategy that was negotiated by FDA and EU representatives in Washington, D.C. in November 1995.

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