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Amendment Of 510(k) Exemption Petition Resets 180-Day Review Deadline

This article was originally published in The Gray Sheet

Executive Summary

Amendment of a 510(k) exemption petition will reset the 180-day review hammer set by the FDA Modernization Act, the agency says in its recently released "Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff."

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