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External device review pilot should await amendments to device law, NEMA says.

This article was originally published in The Gray Sheet

Executive Summary

THIRD-PARTY DEVICE REVIEW PROGRAM SHOULD LIMIT FDA ROLE TO OVERSIGHT, Robert Britain, head of the National Electrical Manufacturers Association's diagnostic imaging and therapy systems division said at a June 19 workshop in Rockville, Maryland. "Final approval authority for new products should rest with accredited third-party reviewers, rather than with FDA itself," Britain stated.
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