FDA PMA Critical to Quality Pilot Program

Participation in the PMA CtQ pilot program is voluntary – the program aims to evaluate device design and manufacturing process quality information early on to assist the FDA in its review of the PMA manufacturing section and post-approval inspections. This voluntary pilot program is part of the FDA’s ongoing Case for Quality effort to apply innovative strategies that promote medical device quality, and is a joint effort between the FDA’s CDRH and Office of Regulatory Affairs (ORA). The program is intended to provide qualifying PMA applicants with the option to engage the FDA on development of CtQ controls for their device and forego the standard PMA pre-approval inspection. FDA would in turn, focus on the PMA applicant’s implementation of the CtQ controls during a postmarket inspection. FDA is seeking companies to volunteer to participate. Full information is at the link provided. Premarket Approval Application Critical to Quality Pilot Program

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.