Continuous Improvement — Not Just Compliance — is Target for FDA’s Case for Quality

The Case for Quality (CfQ) — an FDA initiative in which the agency works closely with the public-private partnership the Medical Device Innovation Consortium (MDIC) — has key programs coming to fruition in its mission to get the industry to focus on continuous improvement in their quality operations.

For instance, the CfQ Voluntary Improvement Program (VIP) is now out of its pilot phase, accepting new participants, exploring ways to enhance its reach to small manufacturers and developing recommendations that will support faster improvements in 510(k) products, Francisco Vicenty, FDA’s program manager for CfQ, told FDAnews.

Participants in the VIP get an annual visit from a third-party quality appraiser to observe the site’s best practices, sharing some of the results with the FDA, but only in a de-identified aggregate format.

The program now has 107 facilities enrolled across 24 device companies, and 92 percent of the time the appraisals found improvements to increase product quality, and 79 percent of the time, the appraisal showed value added beyond product quality because of participation in the program.

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