lunes, 11 de septiembre de 2017

New Voluntary Premarket Approval Application Critical to Quality Pilot Program

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Top-quality medical devices help the FDA better protect and promote public health. The FDA believes that proactive engagement with PMA applicants and a focused inspectional approach will promote quality in device design and manufacturing.
The FDA invites registered and listed firms submitting a Premarket Approval Application (PMA) to consider participating in the Premarket Approval Application Critical to Quality (PMA CtQ) Pilot Program, an effort led by the Center for Devices and Radiological Health (CDRH).
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.
Beginning on September 29, 2017, the FDA will select up to nine PMA applicants for the pilot. The FDA intends to work collaboratively with pilot program participants during the review of their PMA submission to define characteristics of the device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection. For pilot program participants, the FDA would forego conducting the standard PMA preapproval inspection, and a postmarket inspection focusing on the PMA applicant’s implementation of the critical to quality characteristics would be conducted instead.
To learn more about whether your firm may be eligible to participate in the pilot program, see the Participation Factors section of the Federal Register Notice.
Other recently-announced FDA pilot projects built around a goal to streamline the premarket approval process include:


Food and Drug Administration
Center for Devices and Radiological Health

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