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HOUSE FDA REFORM BILL HOLDS OUT FOR THIRD-PARTY SIGN-OFF OF CLASS II 510(K)s; LOWER-RISK NSE DEVICES COULD GET REVIEW VIA 510(K)

This article was originally published in The Gray Sheet

Executive Summary

House FDA reform legislation introduced by Rep. Joe Barton (R-Tex.) on March 29 holds fast to a strong third-party device review mechanism, granting outside organizations the authority to sign off on 510(k) clearances for Class II products. The bill would exempt all Class I devices from premarket notification requirements.
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