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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.

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Case For Quality Belly-Flop? FDA's PMA Critical-To-Quality Pilot Has Zero Enrollees After 10 Months

Device-makers have given a collective shrug to US FDA's Premarket Approval Critical-to-Quality (PMA CtQ) pilot program, a Case for Quality initiative that aims to identify "critical-to-quality" attributes for an array of products and ensure that quality is built into devices at their earliest stages. Since the pilot began in September 2017, no firms have enrolled. FDA's Bleta Vuniqi surmises that the empty pilot might be a victim of a glut of FDA pilot programs. Meanwhile, the agency has been talking internally about ways that the fledgling PMA CtQ pilot could be absorbed by FDA's burgeoning CMMI maturity model pilot.

Number To Know…9

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.

New FDA Pilot Program To Finger ‘Critical-To-Quality’ Points; First Up: Implantables With Batteries

A “critical-to-quality” pilot program will launch early next year to help hone FDA investigators’ attention on manufacturing processes that are essential to the quality of implantable devices that include batteries. The agency, along with manufacturers and other stakeholders, will develop so-called “CTQs” that investigators will use to supplement FDA’s traditional QSIT inspectional approach. If the pilot goes well, FDA will likely develop a similar CTQ model for inspections of manufacturers that make devices other than implantables with batteries. Next for potential CTQS: cardiovascular products, IVDs, and general hospital and surgical devices?

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