The A-list is a forecast, not a deadline.

Once a year, CDRH tells the device industry what it plans to write next. On October 1, 2026, it did this again: three lists, sorted by how firmly FDA commits to each one, covering the fiscal year that runs through September 2027. Read quickly, the lists look like a release calendar. Read against how FDA itself defines the tiers, they are something narrower — a statement of priority, not a schedule.

Three lists, three different promises

FDA sorts its own guidance pipeline into three tiers, and the center’s FY2027 page keeps the same structure its FY2026 page used. The A-list names the priority guidances CDRH intends to publish during the fiscal year. The B-list names guidances it intends to publish only as resources permit. Under Construction names documents FDA intends to develop, also as resources permit, that did not make either list. Each tier is a real commitment of attention — just not the same amount, and the agency says so in its own words rather than leaving the distinction to be inferred.

What made the A-list this year

FY2027’s A-list runs eight items: seven are slated as final guidance, one as draft. Among the final titles are a lifecycle-management guidance for AI-enabled device software functions, a guidance on premarket submissions for robotically-assisted surgical devices, and one titled, without qualification, for predetermined change control plans for medical devices. That last title matters because of what FDA has not yet published: its only final PCCP guidance to date, issued in December 2024, is scoped to artificial intelligence-enabled device software functions specifically — narrower than FD&C Act § 515C, the statute Congress wrote to authorize change-control plans for devices generally, with no AI qualifier in it at all. An A-list entry with the qualifier dropped from its title would be FDA’s implementing guidance finally catching up to the scope its own statute already has. The one draft item on the list covers generative-AI-enabled conversational devices aimed at mental disorders — a category the agency is still defining, not yet one it is prepared to finalize.

A-list, B-list, and Under Construction are not deadlines ranked by urgency. They are three different sizes of commitment, and only one of the three sounds like a promise.

The list is also a comment period

FDA is accepting comment on the relative priority of the A-list and B-list items through November 30, 2026, under the same good-guidance-practices framework that governs every draft before it finalizes. That window is the practical reason to read the lists now rather than wait for a Federal Register notice: ranking a guidance you care about onto the A-list, or off the B-list and onto Under Construction, is a comment FDA is explicitly asking for this year, not a request made after the fact.

Appearing on the list is not the same fact twice

This product has already covered what Under Construction can mean in practice: FDA’s 2023 draft guidance on selecting a 510(k) predicate has sat there, unfinished, since before FY2026 existed, with no date attached to when — or whether — it moves. Nothing about the FY2027 lists changes that example; it is simply this year’s reminder that a tier is a forecast of attention, not a filing with a clock on it. The operating habit this suggests is narrow and specific: track the guidance you depend on by which of the three tiers it currently sits in, not by assuming A-list placement means a date on your calendar. It doesn’t say that, and FDA has never claimed it does.

This is regulatory intelligence and method, never regulatory advice: which list a guidance sits on is a fact about FDA’s own stated priorities, not a commitment a device company can rely on for its own submission timeline.