Sources, retrieval, and limits

FDA device list

Device rows come from the CSV linked on the FDA AI-enabled medical device list. The download used for this copy is https://www.fda.gov/media/178541/download?attachment. The page also links an Excel file and an XML file. The build reads the CSV after finding the link in the page HTML.

FDA says the list is not a comprehensive set of AI-enabled devices. Inclusion depends on AI-related terms in a public summary or on the device classification, and on summaries available in the collection window. The decision-date, submission number, device name, company, lead panel, and primary product code are copied from the file. The database URL follows the link pattern on that same FDA page: 510(k), De Novo, or PMA.

openFDA

Product-code name, definition, class, and regulation number come from the openFDA device classification endpoint. Decision description, decision code, clearance type, and the statement-or-summary label come from the 510(k) endpoint, which also returned the De Novo numbers checked here. PMA rows are matched only when an openFDA decision date equals the FDA list date. 181 of 181 product codes matched a classification record. 1608 of 1614 submissions have an openFDA decision record. Missing enrichment is left blank. Street addresses and contact names from openFDA are not stored.

Classification data last updated field: 2026-10-12. 510(k) data last updated field: 2026-10-12. Requests use a descriptive User-Agent, a short pause between calls, and retries with backoff. No API key is required. An optional key can be supplied as an environment variable and is not written into the site.

Federal Register

Documents are queried from January 1, 2024, for five terms: prior authorization, clinical decision support, artificial intelligence, electronic prescribing, and Part D. Agencies queried: FDA, CMS, and the HHS Department. Department results are dropped when the record belongs to an operating division such as NIH or CDC. The search API also returns documents that do not repeat the phrase in the title or abstract. This site keeps a document only when the title or abstract contains the phrase, so the reason for inclusion is visible.38 documents were kept. Comment-close and effective dates are stored only when the API returns a calendar date.

Summaries and the weekly file

Device paragraphs are a template over the stored fields. An optional model rewrite exists in the code and does not run unless a provider key is present and the monthly budget is above zero. The default budget is zero, so this site uses the template. A weekly issue is skipped, and only logged, when the combined count of new device decisions, in-window documents, in-window milestones, and upcoming comment deadlines is below the configured minimum. The default minimum is 5.