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.