Recognized. Not published.
FDA's 2023 guidance formally recognizes the Voluntary Improvement Program, a third-party quality-maturity appraisal, and ties real regulatory opportunities to it — risk-based inspection planning, faster PMA manufacturing-change tracks. No public FDA database records which firms or sites have been appraised.
By Connor Griggs — Regulatory & Quality Strategist
FDA does not run the appraisal, does not publish who has taken it, and does not put a result anywhere a portfolio watch could read. It nonetheless wrote a guidance document formally recognizing the program and describing, in writing, what a passing appraisal can buy a manufacturer at FDA. The recognition is real. The record of who holds it is not.
What FDA actually recognized
The Voluntary Improvement Program (VIP) is a third-party quality-maturity appraisal, run through the Medical Device Innovation Consortium and ISACA, that scores a manufacturing site’s practices against a device-specific adaptation of the Capability Maturity Model Integration framework — a maturity-scoring approach used well outside medical devices. FDA does not administer the appraisal. FDA’s role, set out in a final guidance issued September 2023, is to describe how the agency will engage with a site once it has one: weighing appraisal participation in risk-based inspection planning, and in eligibility for faster PMA manufacturing-change tracks — a 30-Day Notice, a site change, a manufacturing module — that a lower-maturity site would not get.
No field, because there is no database
Every other fact this blog has traced back to a missing field lives somewhere structured first — openFDA carries the record, and the gap is what one column doesn’t say. VIP participation has no such home to be missing from. MDIC has not published a public roster of appraised sites; FDA’s own guidance describes the program’s mechanics and its regulatory weight without listing a single participant. A site’s VIP status is not a fact withheld from an existing FDA database. It was never the kind of fact FDA’s public databases are built to carry.
A quality signal FDA has agreed to act on, and a quality signal FDA has agreed to publish, turned out to be two different commitments — and only one of them was made.
The method
A competitor’s warning letters, recalls, and 510(k) history are readable because FDA’s own systems produce them as a byproduct of enforcement and clearance work — a monitoring feed inherits that structure for free. A competitor’s quality-maturity appraisal was built the opposite way: voluntary, run by a third party, and reported to FDA on terms the guidance leaves to the participant and FDA to work out directly. No public feed, including this one, closes that gap by reading harder; the gap is the design, not an omission. This is regulatory intelligence and method, never regulatory advice about what a specific site’s absence from public VIP information should be read to mean.
Primary sources
- Federal Register — Fostering Medical Device Improvement: FDA Activities and Engagement With the Voluntary Improvement Program; Guidance for Industry and Food and Drug Administration Staff; Availability (Sept. 15, 2023)
- FDA — Voluntary Improvement Program
- Medical Device Innovation Consortium — Voluntary Improvement Program (VIP)
- FDA Radar — what we monitor and how often
Regulatory intelligence, not regulatory advice. This post describes method and published FDA records as of its date; decisions about a specific device belong with your regulatory professional.