Administrative Simplification

FDA Keeps Its Medical-Device Quality Program Private—and Largely Unchanged

FDA is asking the Office of Management and Budget to renew the paperwork authority for its Voluntary Improvement Program, the agency’s third-party…

Matt Reid

— 2 min read
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FDA is asking the Office of Management and Budget to renew the paperwork authority for its Voluntary Improvement Program, the agency’s third-party appraisal initiative for eligible medical-device manufacturers. The October 1 notice preserves the program’s basic bargain: manufacturers can use individualized quality assessments, while FDA receives appraisal information without turning the program into a compliance regime or a public scorecard. Comments on the information collection are due November 2, 2026.

What It Is

The Voluntary Improvement Program grew out of FDA’s medical-device manufacturing and product-quality pilot. It is facilitated by the Medical Device Innovation Consortium and uses third-party appraisers to assess participating manufacturers’ capabilities and practices. FDA describes the program as a tool for guiding quality improvement, not enforcement; participation is limited to eligible manufacturers of devices regulated by the Center for Devices and Radiological Health.

What’s Changing

Mostly, the paperwork math. FDA is seeking an extension of OMB Control No. 0910-0922 and now estimates 6,056 annual reporting hours—2,009 fewer hours and 200 fewer responses than before—based on device registration and listing data plus informal stakeholder feedback.

The more revealing part is what FDA declined to change after receiving one public comment. The commenter urged the agency to publish de-identified benchmark data, collect repeat-nonconformance information, standardize appraisal summaries, and make repeat submissions easier. FDA said benchmark data will remain available to participants rather than the public, recurrence data falls outside the collection’s scope, and individualized appraisals make cross-company standardization of limited value. It also retained the 20-hour estimate for preparing an appraisal summary, explaining that the estimate covers the third-party appraiser’s work, not the manufacturer’s preparation time.

Why It Matters

For device makers, the notice signals continuity: the program remains voluntary, tailored, and separate from FDA’s compliance machinery. That flexibility may make participation more attractive, but it also limits what outsiders can learn from the resulting quality data. Health systems, physicians, and patients will not gain a new public benchmark for comparing manufacturers, and the collection will not track whether previously corrected problems recur.

That does not make the program toothless; it means its value is concentrated among participants and FDA rather than translated into broad market transparency. The current proceeding is a Paperwork Reduction Act review, not a new device-quality rule, so comments are aimed at the necessity, utility, and burden of the collection—not at rewriting the entire program by November.

The practical headline is modest but useful: FDA wants the quality-improvement pipeline renewed without widening the pipe. Read the notice and submit comments through the Federal Register (https://www.federalregister.gov/documents/2026/10/01/2026-20085/agency-information-collection-activities-submission-for-office-of-management-and-budget-review).

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