MDUFA VI is being negotiated in public

MDUFA V funds FDA’s device review program through fiscal year 2027. The program that replaces it — MDUFA VI — does not exist yet, has no fee table, and will not take effect until fiscal year 2028. None of that has kept its negotiation off the public record. By statute, most of it has to be.

What the statute requires FDA to do out loud

Section 738A of the FD&C Act (21 U.S.C. § 379j-1) governs how FDA develops its recommendations for a reauthorized device user-fee program, and it does not leave that process to be worked out quietly between FDA and industry and announced once it’s finished. FDA has to consult a defined set of stakeholders while developing recommendations — regulated industry, patient and consumer advocacy groups, health care professionals, scientific and academic experts — and the statute sets a specific cadence for one of those groups: discussions with patient and consumer advocacy representatives no less often than once a month, for as long as negotiations with industry continue. Once FDA and industry reach recommendations, the statute doesn’t let those stay private either — FDA has to publish them in the Federal Register, hold a public meeting where anyone can weigh in, and hold open a public comment period before the recommendations go to Congress.

What that looks like in 2026

FDA opened the MDUFA VI docket with a Federal Register notice on July 8, 2026— Medical Device User Fee Amendments; Public Meeting; Request for Comments — publishing proposed recommendations and announcing a public meeting held August 5, 2026, with a public comment window behind it. That notice sits squarely inside FDA Radar’s own device-relevance filter: its title contains the phrase “medical device,” the same term that flags a classification order or a 510(k) rule. The stakeholder consultation meetings that built the recommendations before that notice ever published are a different record. FDA has been posting minutes from those sessions — running back through late 2025 — directly to its own MDUFA VI program page, not to the Federal Register, not to any docket, not through any API.

A Federal Register notice is the one moment this process is required to look like a document. Almost everything the statute actually requires — the monthly meetings, the running consultation — happens as a standing item on FDA’s own site, with nothing else pointing to it.

The practice

The single notice a Federal Register watch would catch is the summary, not the negotiation — everything that built it lives as a sequence of dated postings on FDA’s own MDUFA VI page, worth checking directly rather than waiting for a docket to summarize it. A small RA team operating fee tables and submission timelines built around MDUFA V has roughly a year and a half before whatever comes out of this process replaces them, and the draft of that replacement is being assembled, in public, right now. This is a description of where that record lives and what the statute requires FDA to publish, never advice about what a specific fee schedule or submission strategy should assume before FY2028 arrives — that reading is a regulatory professional’s.