On October 1, the FDA's device center, CDRH, posted the guidance documents it intends to publish between now and next September. On the same page it reported that it delivered seven of the eleven it promised last year. For a company filing in the next year or so, those two facts bear on a choice the regulatory plan has to make: build to the draft guidance that exists today, or wait for the final version the agency says is coming.
What the three lists say
CDRH sorts its agenda into three lists. The A-list holds its priorities for the year: seven final guidances and one new draft. The B-list holds documents it will publish as resources permit, three final and two draft. A third list, labeled Under Construction, covers work the center intends to develop with no year attached.
Most of the A-list finishes work already in draft. Makers of AI-enabled device software are due a final version of the guidance on what their marketing submissions should contain. A final guidance on predetermined change control plans, the mechanism for getting planned future modifications authorized in advance, applies to any device. Surgical robot companies are due the final premarket guidance for robotically assisted devices, which first appeared as a draft in September 2026. And the A-list's one new draft sets out the evidence expected for generative AI conversational devices that treat mental disorders.
Two B-list documents apply well beyond one device type: a final version of the Q-Submission program guidance, which governs how any sponsor asks the FDA for feedback before filing, and a new draft on postmarket cybersecurity. Under Construction holds a guidance on choosing a 510(k) predicate and another on risk assessment for generative AI devices.
The track record sits on the same page
Below the lists, CDRH grades itself. Of the 11 guidances on last year's A- and B-lists combined, it published seven, five from the A-list and two from the B-list; the page doesn't give the A-list's rate on its own. The center also commits to act on 80 percent of draft guidances within three years of the comment period closing, and on all of them within five. Two drafts issued before October 2020 are still waiting for any action, so a draft can stay a draft for years.
A promised final, then, has reasonable odds of arriving within the year and a real chance of slipping past it, and a schedule that needs a final by a certain month carries that risk. The current draft is the most detailed statement available of what reviewers will ask for. I'd build the submission to it and treat the final as a revision you expect.
Mapping the list against your submission
Put your planned submission date on a page and mark every item on the three lists that touches your device type, your software or your regulatory pathway. For each, write down what would change in your submission if the final version posted between design freeze and filing. That takes about an hour.
For a surgical robot, look first at the performance testing the September draft describes, since bench and clinical data are slow to regenerate once the design is frozen. For AI software, look at the change control plan, which both the AI guidance and the change control guidance address. A company that expects a pre-submission meeting to settle its strategy should watch the Q-Submission final for any change to how those meetings are requested and answered.
Each marked item goes on the risk register with an owner who checks the FDA guidance page and a trigger: the work the team starts the week a final version posts.
The comment window closes November 30
CDRH is taking comments on the lists through November 30, under docket FDA-2012-N-1021 on regulations.gov. It asks which A- and B-list items should come first and invites proposals for new guidance. If a final version on the list sits on your critical path, a two-page comment explaining what its timing means for a small company's submission is cheap to write and goes on the public record.
Commenting is one way to influence a date your team doesn't control. A device roadmap carries several of those: the guidance calendar, a supplier's lead time, a standards revision. For each one I ask what we'd do if it slipped six months, and whether that answer is written down anywhere.
Dave's take
What makes CDRH's list useful is the report card printed beneath it. I'd keep the same record for every outside party a roadmap depends on: the date promised and the date delivered, written down each time. After a year of that, the plan rests on measured odds instead of somebody's optimism.
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Today's Monday MedTech covers Stryker putting $400 million into a surgical robot that another company builds.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for product companies. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →