Fdarecords

fdarecords

FDA records without the portal spelunking. fdarecords is a small client for the openFDA API that covers the two lookup jobs people actually repeat: finding drug information — label text, the Drugs@FDA application behind a product, the application numbers behind a name — and tracing a medical device from its submission number to its regulatory class.

Seven tools do the work. Three of them lean on findings from the original project worth knowing up front: De Novo (DEN) numbers are filed inside the 510(k) endpoint's k_number field, because openFDA has no De Novo endpoint of its own; HDE (H) numbers are not in openFDA at all, so an H lookup answers null without pretending otherwise; and the validation chain still reports class III for an H number, labelled as regulatory inference rather than data.

One tool is a research aid, not an oracle: screen_for_rwe_signals sweeps drug labels for real-world-evidence vocabulary and returns whatever it finds. It is experimental and unvalidated — treat its hits as candidates for a human to review, never as findings.

Configuration

• OPENFDA_API_KEY (optional) — an openFDA API key. When set it travels as the api_key query parameter and buys higher rate limits. Nothing requires it; every tool works keyless.
• OPENFDA_BASE_URL (optional) — API base URL. Defaults to https://api.fda.gov.

The result contract

Every tool follows the same rules, and they are worth stating plainly because they decide what a "no" looks like:

• A query that matches nothing returns the JSON text null. That covers an HTTP 404 and a 200 whose result list is empty.
• A transient failure — a timeout, a connection error, a 429, a 5xx — is retried twice with backoff. If it still fails, the tool raises openfda transient failure: .... A transient failure is never reported as a miss, so a null always means "not there", never "couldn't ask".
• Any other rejected request (a different 4xx) raises openfda request error: HTTP immediately.
• Bad arguments fail before any request: must be a non-empty string, or limit must be an integer between 1 and 100.

Single-record tools return the first matching record as JSON. The two label tools return the upstream response body exactly as it arrived.

Tools

• search_drug_label — search SPL label text for a query. Pass a section (an SPL field name such as indications_and_usage) to confine the search to that section. Optional limit, default 10.
• lookup_drugsfda_application — the Drugs@FDA record for an application_number (NDA, BLA and ANDA numbers all work).
• resolve_drug_to_application — go from a brand or generic name to the application numbers filed under it, returned as a sorted JSON array of distinct strings.
• screen_for_rwe_signals — the experimental sweep described above. An optional query adds one more term to the fixed signal set; optional limit, default 10.
• lookup_device_submission — a device record for a submission_number. K and DEN numbers search the 510(k) endpoint; P numbers search the PMA endpoint; H numbers return null (not in openFDA); anything else is rejected as an unrecognized prefix.
• classify_device_product_code — the device class and medical specialty for a product_code.
• validate_device_application — the full chain in one call: from submission_number through its product code to device_class, medical_specialty and device_name, with a device_class_source saying where the class came from. H numbers short-circuit to the labelled inference result; a record with no product code comes back with "device_class": null merged in.

Endpoint provenance

GET /drug/label.json is the path pinned on the openFDA API index. The remaining paths follow the same documented pattern for their endpoint families and are labelled as pattern-derived rather than pinned:

• GET /drug/drugsfda.json — pattern-derived
• GET /device/510k.json — pattern-derived
• GET /device/pma.json — pattern-derived
• GET /device/classification.json — pattern-derived

Three behaviours are compositions built for this client, and are labelled as such in the code: how resolve_drug_to_application merges its brand-name and generic-name queries, the signal term set screen_for_rwe_signals searches for, and the shape validate_device_application composes from its two records.

CLI

Each tool is a subcommand taking one JSON argument string:

npx @reneturcios/fdarecords search_drug_label '{"query":"aspirin"}'

npx @reneturcios/fdarecords search_drug_label '{"query":"chest pain","section":"indications_and_usage","limit":25}' npx @reneturcios/fdarecords lookup_drugsfda_application '{"application_number":"NDA021457"}' npx @reneturcios/fdarecords resolve_drug_to_application '{"name":"Tylenol"}' npx @reneturcios/fdarecords screen_for_rwe_signals '{"query":"diabetes"}' npx @reneturcios/fdarecords lookup_device_submission '{"submission_number":"K123456"}' npx @reneturcios/fdarecords classify_device_product_code '{"product_code":"ABC"}' npx @reneturcios/fdarecords validate_device_application '{"submission_number":"H123456"}' npx @reneturcios/fdarecords --version

Output is the tool's result text (null, a record, an array, or the upstream body). Exit codes: 0 on success, 1 on a runtime error (including a validation or upstream failure), 2 on a usage error.

MCP server

npx -y @reneturcios/fdarecords mcp

MCP client config:

{

"mcpServers": { "fdarecords": { "command": "npx", "args": ["-y", "@reneturcios/fdarecords", "mcp"] } } }

Docker

docker run -i ghcr.io/cloudcorprecords/fdarecords

docker run --rm ghcr.io/cloudcorprecords/fdarecords lookup_device_submission '{"submission_number":"DEN200001"}'

Development

npm install

npm run build # tsc -> dist/ npm test # tsx --test test/*.test.ts (fake fetch only, no network) npm run dev # run the CLI from source

License

MIT — Copyright (c) 2026 Rene Turcios