Collaborative Communities: Teaming Up with FDA to Solve Shared Challenges

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ARTICLE SUMMARY:

Collaborative Communities are designed to bring together patients, providers, industry, regulators, payors, and other key medical device stakeholders in an open environment to tackle broad challenges, where each member has an equal voice. To date, FDA participates in six of them; MDIC’s Case for Quality Collaborative Community is the latest addition.

On October 7, the FDA announced that the Medical Device Innovation Consortium’s (MDIC) Case for Quality Collaborative Community (CfQcc) had achieved recognition as a Collaborative Community with participation by CDRH. The CfQcc offers a unique opportunity for medical device stakeholders to work together, via a variety of focus areas, to enhance device quality and patient safety. The program will allow FDA to identify device manufacturers that consistently produce high-quality devices, which enables the agency to allocate its resources to assist other manufacturers with increasing their level of device quality. MDIC’s partnership will enable the organization to help FDA with recognizing and supporting practices that encourage consistent quality manufacturing.

“Collaborative Communities” have become an FDA and device industry buzzword over the past year or so, but what are they and what is the value of being involved in one? Market Pathways spoke with Alan Baumel, Program Director of the Case for Quality at MDIC, for some clarity and background.

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