filings/
The project’s submissions on public dockets. Rule of the shelf: what is filed is published here verbatim, as filed, with docket, date, and tracking number; drafts are marked as drafts until then. Nothing summarized, nothing paraphrased — the administrative record and this folder should be diffable.
| Docket | Subject | Our questions | Deadline | Status |
|---|---|---|---|---|
| FDA-2026-N-7874 | GenAI-enabled medical devices — discussion paper | 18, 21, 25, 26 | 19 Oct 2026 | Draft — fda_2026_n_7874_comment.md |
Also on this shelf. Does the frontier touch medicine? — what FDA can and cannot currently see, and why one in five American adults is already taking medical advice from a frontier model outside every mechanism designed to catch it. Who actually files — three hundred and forty million people, fifty-one comments, twenty-one of them industry, deciding how these systems may be used on children and on people at their worst moments. The field guide — how anyone files a federal comment, the identity cards and category codes decoded. Reading notes on FDA-2024-D-4488 — the predecessor docket’s 51 comments, indexed. Banked threads — campaign-layer drafts, counted and sourced, held until fired.
A supplemental comment is ordinary administrative practice: the docket stays open until the deadline, filings post publicly as processed, and a short reply answering what industry files is held as an option for the final week.
The paper under comment: Considerations for the Regulation of Generative AI-Enabled Medical Devices (FDA/CDRH, August 2026).
Table of contents
- Who actually files — the room where it is decided, and how few people are in i
- How to file a federal comment — a field guide
- Does the frontier touch medicine? — what the regulator can and cannot see
- Filed comment — FDA-2026-N-7874 (GenAI-enabled medical devices)
- Reading notes — Docket FDA-2024-D-4488