Posted 11 September 2017
By Zachary Brennan
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will lead a pilot program to define characteristics of a device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection.
The voluntary pilot, which will run from 29 September to 31 December 2018, invites firms submitting a Premarket Approval Application (PMA) to consider participating in the Premarket Approval Application Critical to Quality (PMA CtQ) Pilot Program.
"The goal of this voluntary pilot—a part of CDRH's Case for Quality—is to streamline the premarket approval process while assuring that a firm's quality system includes rigorous controls for characteristics considered critical to the safety and effectiveness of the medical device," FDA said.
Nine PMA applicants will participate in the pilot and FDA said that for those participants, the agency would forego conducting the standard PMA preapproval inspection, but instead conduct a postmarket inspection focusing on the PMA applicant's implementation of the critical to quality characteristics.
Federal Register Notice