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

 
• By Shawn M. Schmitt

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.

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Manufacturers have given a collective shrug to an in-progress US FDA pilot program 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.

More than 10 months after open enrollment for the Premarket Approval Critical-to-Quality (PMA CtQ) pilot began, the tally of firms participating in it is zero.

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