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510(k) third-party review program

This article was originally published in The Gray Sheet

Executive Summary

FDA expects to receive 140 premarket notifications annually from outside reviewers under the "Accredited Persons" program mandated to begin Nov. 21 by the FDA Modernization Act, the agency says in an Oct. 30 Federal Register notice. FDA anticipates accrediting 35 third parties, each of which is expected to process four 510(k)s a year. Since the inception of its third-party review pilot in August 1996, FDA has received thirty-two 510(k)s, agency staffers say



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