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Third-party comprehensive, standards-based 510(k) review program planned by FDA.

This article was originally published in The Gray Sheet

Executive Summary

THIRD-PARTY COMPREHENSIVE, STANDARDS-BASED 510(K) REVIEW to support FDA substantial equivalence decisions is being pursued by the agency in its development of a third-party review pilot program. As recommended by some industry representatives at a June 19 workshop in Rockville, Maryland, this approach would give third parties a significant role in reviewing 510(k)s and would bring product evaluations more in line with other countries' standards-based premarket review systems.

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