On September 12, 2017, CDRH announced the Premarket Approval Application Critical to Quality (PMA CtQ) pilot program which is part of the FDA’s ongoing Case for Quality effort to apply innovative strategies that promote medical device quality. Participation in the PMA CtQ pilot program is voluntary. The pilot program aims to engage qualifying PMA applicants early in the PMA review cycle with a focus on what the applicant has established as the Critical-to-Quality (CtQ) attributes, characteristics, and controls for the PMA device. FDA would provide feedback on the identified CtQ characteristics and controls for their device and forego the standard PMA preapproval inspection. FDA would, in turn, focus on the PMA applicant’s implementation of the CtQ controls during a postmarket inspection.
Representatives from CDRH and industry will discuss the pilot, clarify key concepts and terminology, address some of the learnings to date, as well as provide examples of device-related CtQ characteristics and controls. Additionally, FDA would like to discuss additional options to leverage value and impact from this pilot. Slides available here.