Sep 11, 2017
EMERGO SUMMARY OF KEY POINTS:
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.
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.
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 FDA notice lists qualifications and steps applicants should take in order to be eligible for participation in the pilot:
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.
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans revisions to its Investigational Device Exemption process to improve clinical trial management for manufacturers and sponsors, and may also consider down-classifying some devices from Class III Premarket Approval registration requirements.
The CRDH’s plans were announced as part of the department’s 2014 Strategic Priorities, which also include “customer service” initiatives.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: