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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