US FDA Launching New Premarket Approval (PMA) Pilot Program for High-risk Medical Devices

EMERGO SUMMARY OF KEY POINTS:

• The US FDA is setting up a pilot program to make its Premarket Approval (PMA) review process for high-risk medical devices more efficient.
• The agency is seeking nine PMA applicants for participation in the program.
• The agency will consider PMA applicants for participation in the program starting in late September 2017.

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to launch a new pilot program to develop a more efficient premarket approval (PMA) market pathway for some high-risk medical devices.

The pilot, called the Premarket Approval Application Critical to Quality (PMA CtQ) program, will commence on September 29, 2017. Starting on that date, CDRH will choose as many as nine PMA registrants to participate in the PMA CtQ pilot.

PMA CtQ program goals

According to CDRH, PMA CtQ entails a “focused inspectional approach” to the PMA process in order to boost medical device design and manufacturing quality. The pilot is intended 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 the postmarket inspection.”

By focusing on quality issues in collaboration with PMA applicants before market authorization, US regulators hope to drive down high-risk device failures and recalls, as well as to reallocate some post-market resources to other areas.

Ultimately, the PMA CtQ pilot is intended to streamline the complex and expensive PMA process without compromising controls for safety and effectiveness of devices. The pilot may lead to less costly and time-consuming premarket requirements for manufacturers of implantable and other high-risk devices.

How the pilot will work 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 FDA PMA CtQ notice emphasizes that the pilot will not replace the FDA’s conventional Quality System Inspection Technique (QSIT) inspection program, but rather will augment QSIT when appropriate.

The PMA CtQ qualification process

The FDA notice lists qualifications and steps applicants should take in order to be eligible for participation in the pilot:

• 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 postmarket 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.

PMA CtQ pilot timelines

FDA officials will accept requests for participation in the PMA CtQ pilot from September 29, 2017 to December 31, 2018, or until nine suitable participants have been identified and enrolled.

Additional US FDA PMA resources from Emergo:

• FDA Pre-Sub (Q-Sub) consulting for medical device companies
• Medical device design, process and software validation support services
• In-depth video: US FDA medical device registration and compliance
• Whitepaper: What to expect during an FDA QSR inspection