FDA addresses the need for a more efficient pre-market approval pathway for high risk medical devices

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has released plans to launch a new pilot programme for high-risk medical devices.  The “Premarket Approval Application Critical to Quality (PMA CtQ)” programme is due to start on 29th Sep 2017.  On this date, around nine PMA applicants are expected to take part.

Through the pilot, CDRH aims to “define characteristics of the PMA device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to post-market inspection.”  PMA applicants that qualify for the pilot will not undergo pre-approval inspections; instead, CDRH will carry out inspections post-approval focusing on design, manufacturing and quality assurance practices specific to each applicant, augmenting the existing Quality System Inspection Technique (QSIT) inspection programme.

In contrast to the existing approval process for such devices, the PMA CtQ pilot offers a more streamlined and inexpensive pathway, which is ultimately expected to reduce device failure rates on the US market.  Needless to say, these changes are expected to result in a reallocation of post-market resource to other areas within the CDRH.

The FDA will be ‘recruiting’ applicants for the PMA CtQ pilot as early as 29th Sep 2017 and will continue until 31st Dec 2018.  Requests for acceptance into the programme will be extended however, until a sufficient number of applicants have been enrolled.

Are you a manufacturer of a high-risk medical device that will benefit from post-approval inspections in the US?  If so, click here to review FDA’s list of qualifications and steps required for eligibility into the programme.