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Number To Know…9

Executive Summary

US FDA will select nine manufacturers for a voluntary "Premarket Approval Application Critical to Quality" pilot program to assist the agency's review of the manufacturing section of a PMA and post-approval inspections, and provide a change for firms to skip a pre-approval audit.

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Device-Makers Can Forego US FDA Pre-Approval Inspections By Joining New 'Critical-To-Quality' PMA Pilot

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