openFDA Regulatory Metadata

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Works with Claude Code, Codex, VS Code, Cursor, Windsurf, Claude Desktop. Read the repository before you give any tool access to your data.

npx agentmarket install connector/blackswancausallabs-com-openfda-mcp

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What this server can do and what it asks for, from its tool list and install config. Checked Oct 25, 2026.

Tools

5 read · 1 write · 0 delete · 1 not yet classified

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Python package

Tools (7)

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• classify_device_product_code

  Resolve a CDRH product code to its device class and medical specialty. Args: product_code: The 3-letter CDRH product code, e.g. "HQD", "SDQ". Returns: {device_class: 'I'|'II'|'III', medical_specialty, device_name_generic}. Values are None when the code is not found.

• lookup_device_submission

  Look up a CDRH device submission by its number. Handles all four device pathways: 510(k) K-numbers ("K203571"), De Novo grants ("DEN160026" — stored in the 510(k) endpoint, not a separate one), PMA P-numbers ("P230044"), and HDE H-numbers. Supplement suffixes ("P230044/S001") are stripped before lookup. Args: number: Device number with prefix. Case-insensitive. Returns: The openFDA device record (applicant, device_name/trade_name, product_code, decision_date, ...) plus an '_endpoint' marker naming the endpoint that matched, or {"found": false} if openFDA has no record. N…

• lookup_drugsfda_application

  Fetch Drugs@FDA application metadata for an NDA/BLA/ANDA number. Args: application_number: The number WITH its prefix ("NDA021436", "BLA761180"). Case-insensitive. A bare digit string will not match — Drugs@FDA stores the prefix as part of the value. Returns: Parsed JSON with sponsor_name, application_type, products and submission history. Empty 'results' if not found — note that CBER products (vaccines, cell and gene therapy) are frequently absent by design.

• resolve_drug_to_application

  Resolve a brand or generic drug name to its NDA/BLA application number(s). Bridges drug-name-only sources (registry inventories, product lists) to FDA regulatory metadata. Searches the brand and generic name fields directly rather than label prose, so another product merely *mentioning* this drug does not produce a false match. Args: drug_name: Brand or generic name, e.g. "Adbry" or "tralokinumab". limit: Max label records to aggregate (default 10). Returns: {query, n_matches, matches[]} where each match carries application_number plus the brand/generic/manufacturer/route me…

• screen_for_rwe_signals

  EXPERIMENTAL. Sweep drug labels for registry / real-world-evidence signals. Searches the label corpus for terms suggesting registry, natural-history or other real-world evidence, then aggregates hits by application number with snippets showing where each term matched. **This tool is unvalidated and has a known false-positive problem.** It has no ground-truth oracle, and below the strongest hits the results are dominated by applications whose labels use "registry" in an unrelated sense. Its output is a candidate list for human review — not a finding, and not a count you should report. Args: …

• search_drug_label

  Search openFDA drug labels (SPL) for a term. Args: term: Search term. Quote multi-word phrases, e.g. '"natural history"'. section: Optional SPL section to scope to (e.g. "clinical_studies"). Defaults to searching the RWE-relevant sections together. limit: Max results per page (1-1000, default 100). skip: Pagination offset. Returns: openFDA's parsed response. The 'results' array holds label records, each with an 'openfda' metadata block plus the text of matching sections.

• validate_device_application

  Validate a device number and derive class, specialty and category in one call. Chains lookup_device_submission -> classify_device_product_code, which is the full three-hop resolution: number -> product_code -> classification. Args: number: Device number with prefix (K/DEN/P/H). Case-insensitive. Returns: Flat dict with number, submission_type, validated, applicant, device_name, product_code, decision_date, device_class, medical_specialty, intended_use, product_category. 'validated' is False when openFDA has no record; for HDE numbers device_class is still reported as…

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Last commit

Aug 7, 2026 (2 months ago)

Last release

Aug 7, 2026 (2 months ago)

Last package publish

Aug 7, 2026 (2 months ago)

From GitHub (fetched Oct 24, 2026) and the package registry.

Details

Registry name

com.blackswancausallabs/openfda-mcp

Version

0.1.0

Auth

No auth

Packages

pypi openfda-mcp

License

MIT

Repository

github.com/Black-Swan-Causal-Labs/openfda-mcp

First seen

Oct 24, 2026

Last checked

Nov 1, 2026

Source

Official MCP Registrygithub-graphql