FDA Releases Case for Quality Pilot Program Report, Seeks Feedback


MDIC, on behalf of the U.S. Food and Drug Administration (FDA), is seeking public comments on a new report from FDA’s Case for Quality program, Voluntary Manufacturing and Product Quality Pilot Program Results.

FDA engaged with MDIC in 2014 to develop an ongoing forum to bring stakeholders across the medical device ecosystem together to collaborate on objectives for the Case for Quality. Through MDIC, it was identified that a different approach for evaluating quality execution was needed to increase the focus on quality not just compliance.

In January 2018, FDA launched the Voluntary Manufacturing and Product Quality Pilot Program (The Pilot) that applied a tailored-approach of the CMMI Maturity Model Rev 2.0 along with complimentary changes in FDA regulatory activities. The Pilot focused on manufacturing and the associated support functions and enabled FDA to evaluate the adapted review approaches on manufacturing submissions required for Pre-Market Approval (PMA) devices. This report outlines details and results from the Pilot and recommends that the Pilot be converted into full operational program within the medical device ecosystem.

View the report here.

The public comment period is open September 24 – October 24, 2019.

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