FDA New Premarket Approval (PMA) Pilot Program for High Risk Medical Devices
The US Food and Drug Administration (FDA) plans to launch a new pilot program called the Premarket Approval Application Critical to Quality (PMA CtQ), to develop a more efficient premarket approval (PMA) market pathway for some high-risk medical devices.
The Agency is seeking nine companies to participate in its Premarket Approval Application Critical to Quality program beginning Sept. 29 and running to either Dec. 31, 2018, or until nine PMAs have enrolled. The goal is to streamline the PMA process “while assuring that a firm’s quality system includes rigorous controls for features and characteristics considered critical to the safety and effectiveness of the device,” the FDA said.
Advantage for participants
PMA applicants that qualify for the PMA CtQ pilot will not undergo preapproval inspections; instead, CDRH will carry out post-approval inspections focusing on design, manufacturing and quality assurance practices documented by each registrant in its PMA submission. The PMA CtQ will not replace the FDA’s conventional Quality System Inspection Technique (QSIT) inspection program, but rather will augment QSIT when appropriate.
Qualification process for PMA CtQ
Applicant should first submit a pre-PMA Q-submission meeting request at least 75 to 90 days ahead of submitting a full PMA application according to the guidance document “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.”
The Q-sub request should include a statement in support of being considered for participation in the pilot. Also, the applicant should provide a list of its facilities involved in its device manufacturing, packing and related operations, as well as a draft list of critical characteristics of the device.
At the Q-Sub meeting, FDA staff will discuss PMA CtQ program expectations and provide feedback to the applicant.
CDRH staff will determine whether all the applicant’s listed facilities have been inspected within the last five years, as well as whether any such inspections resulted in penalties or punitive actions.
FDA accepts the PMA application and files for review along with draft list of critical characteristics, plus a streamlined validation process report to CDRH no later than 45 days into the PMA application process.
CDRH reviewers check CtQ data for clarity, completeness and relevance to FDA Quality System Regulations (QSR) within 45 days of the start of the PMA review process; agency reviewers will aim to finalize list of critical characteristics and related information by day 60 of the 180-day PMA timeline. CDRH will also review the PMA application’s manufacturing section with the first 30 days of the process; any deficiencies found in this review will disqualify the applicant for PMA CtQ participation. In addition, CDRH will review the applicant’s validation report within 30 days of receipt; any deficiencies may delay the PMA review process.
CDRH reviewers will reach an approval decision, after which FDA will conduct a post-market inspection that incorporates the applicant’s PMA CtQ information.
Finally, FDA reviewers and PMA applicant will provide relevant data to assess the PMA CtQ program’s effectiveness on regulatory resource allocation and PMA quality improvement.