FDA Quality Pilot Aims to Streamline Device Review Process

Source: Fierce Biotech

Wednesday, September 13, 2017 | Health Care


The FDA is piloting a new scheme for high-risk medical devices that removes the need for preapproval inspections in return for making more information on device quality available early on, according to a report in FierceBiotech.

The aim is to target the regulator's premarket approval and post-marketing inspections more effectively, and "promote quality in device design and manufacturing," which in turn should reduce device failures and recalls, says the agency in a Federal Register post.

The Premarket Approval Application Critical to Quality (PMA CtQ) pilot is looking for nine device manufacturers willing to collaborate with FDA on identifying the characteristics of a device that are most important for the quality of the product as well as the process used to manufacture it.

Read the full article here.


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