Device-Makers Can Forego US FDA Pre-Approval Inspections By Joining New 'Critical-To-Quality' PMA Pilot
Executive Summary
Nine manufacturers will be selected to play in the agency's voluntary "Premarket Approval Application Critical to Quality" (PMA CtQ) pilot program. Participants will "discuss device design and manufacturing process quality information with FDA early on" to assist "in its review of the PMA manufacturing section and post-approval inspections," the agency says in a notice set to publish in the Sept. 12 Federal Register.