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TESTING LABS APPEAR TO HAVE BEST CHANCE FOR RECOGNITION AS THIRD-PARTY REVIEWERS UNDER FDA PILOT, LEVITT SAYS; INDUSTRY QUESTIONS LABS' EXPERTISE

This article was originally published in The Gray Sheet

Executive Summary

Identification of third-party reviewer organizations that offer both expertise in device regulation and independence from manufacturers could prove to be a key challenge to FDA in implementing its third-party review pilot program. At two FDA events held during the week of April 15, agency officials emphasized the importance of third-party independence while industry reps stressed the need for outside groups with considerable device experience.
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