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U.S./EU device MRA implementation by FDA will rely on outside organizations.

This article was originally published in The Gray Sheet

Executive Summary

U.S./EU MRA IMPLEMENTATION BY NON-FDA U.S. ASSESSMENT BODIES PLANNED by the agency, FDA staffers say. Given its resource limitations, FDA is seeking to outsource the European Union CE mark premarket evaluations and facility inspections for conformance to the EU's EN 46000 series quality systems standards mandated by the June device mutual recognition agreement (MRA).

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