The category is new. The 510(k) record isn't.

A 510(k) record reads the same today as it did last year: K-number, applicant, device name, product code, decision date, advisory committee, a third-party-review flag. None of those fields say how FDA sorted the device’s human-factors risk — and as of this year, every submission has to be sorted.

The category FDA just finished building

FDA’s core guidance on the subject, Applying Human Factors and Usability Engineering to Medical Devices, finalized February 3, 2016 under docket FDA-2011-D-0469, set the standard: identify critical tasks, analyze use-related risk, validate the result with representative users. What it never settled was how much of that work a given submission had to document to prove it. FDA closed that gap on May 29, 2026, finalizing Content of Human Factors Information in Medical Device Marketing Submissions under docket FDA-2015-D-4599 — replacing a December 2022 draft — with a risk-based framework that sorts every 510(k), De Novo, PMA, and HDE submission into one of three Human Factors Submission Categories. Category 1 covers a modified device whose sponsor can show the change adds no new critical task, and asks for a high-level summary. Category 2 covers a device with no critical tasks at all, and asks for the sponsor’s reasoning why not. Category 3 covers a device where critical tasks exist, and calls for a full human-factors engineering report with validation testing behind it. The final guidance also added something the draft didn’t have: Decision Point D, a structured path for a sponsor to argue out of validation testing even where a critical task is present, under conditions the guidance spells out.

Where the category lives, and where it doesn’t

A sponsor declares and justifies its category inside the submission; an FDA reviewer who disagrees pushes back with an Additional Information request, and that exchange stays in the file on both sides. openFDA’s 510(k) endpoint carries k_number, applicant, device_name, decision_date, decision_code, decision_description, date_received, product_code, advisory_committee_description, clearance_type, and third_party_flag — the same fields this product reads today. None of them records a Human Factors Submission Category, whether validation testing ran, or whether a sponsor invoked Decision Point D to skip it.

A 510(k) record says a device cleared. It has never said how FDA judged the risk of someone using it wrong.

The practice

For a multi-product portfolio, knowing which category a given clearance claimed — and whether it held up through review — means pulling the submission file itself, never a public dataset. The Federal Register notice finalizing the May 2026 guidance is exactly the kind of document this blog’s own Federal Register feed is built to catch; what a single device’s own category ends up being is not, and none of the four sources this product ingests — Federal Register notices, warning letters, device recalls, and 510(k) clearances — will ever carry it. This is regulatory intelligence and method, never regulatory advice on which category a specific device should claim.