OpenFDA Regulatory Metadata

What openFDA Regulatory Metadata MCP server does

The openFDA Regulatory Metadata MCP server connects MCP clients to the openFDA API for regulatory information covering CDER, CBER, and CDRH. Its main use is identifier resolution: an agent can start with a drug name or FDA application number and retrieve the corresponding regulatory record, or start with a device submission number and determine related classification data.

Drug and biologic support includes searches over Structured Product Labeling text, lookups for NDA, BLA, and ANDA records in Drugs@FDA, and conversion of brand or generic names into application numbers. The server also provides an experimental sweep for possible real-world-evidence signals in labels. Those results are candidate signals for review, not validated findings or reportable counts.

Device support covers K, DEN, P, and H identifiers. The available operations can retrieve a submission, classify a product code by device class and medical specialty, or run the full application-number-to-classification chain.

How it works

The openFDA Regulatory Metadata MCP server uses the openFDA web API behind MCP tools. Device validation may require multiple lookups: a submission number is resolved to a product code, then the product code is resolved to a classification and specialty. De Novo identifiers are handled through the 510(k) data endpoint, where they appear in the k_number field rather than in a separate De Novo endpoint.

HDE identifiers are different. openFDA does not provide HDE records through the 510(k) or PMA endpoints, so the server reports device class III by regulatory inference while leaving medical specialty unavailable. Results include the source of the device-class value so consumers can distinguish retrieved classifications from this inference.

Request failures are separated from genuine missing records. A 404 or empty result returns None; timeouts, connection failures, rate limits, and server errors are retried with backoff and then raise OpenFDATransientError; other HTTP 4xx responses raise OpenFDARequestError. This distinction prevents temporary outages from being cached as permanent absences.

Setup and configuration

Install the package with:

pip install openfda-mcp

Register it as a stdio MCP server using the openfda-mcp command. The supported environment variable is OPENFDA_API_KEY. It is optional: unauthenticated access is limited to 40 requests per minute and 1,000 per day, while a free FDA API key raises those limits to 240 per minute and 120,000 per day.

For research workflows, pin the package version. The README identifies openfda-mcp v0.1.0 as the version used for the referenced application-resolution work.

Tools and capabilities

• search_drug_label: searches label text, optionally within a selected section.
• lookup_drugsfda_application: retrieves an NDA, BLA, or ANDA record.
• resolve_drug_to_application: maps a brand or generic name to application numbers.
• screen_for_rwe_signals: performs an experimental label sweep for possible RWE signals.
• lookup_device_submission: retrieves a K, DEN, P, or H submission record.
• classify_device_product_code: maps a product code to device class and specialty.
• validate_device_application: performs the complete device validation chain.

Limitations and notes

The openFDA Regulatory Metadata MCP server depends on data available from the openFDA API. HDE specialty data cannot be retrieved, and the reported class III value for HDE records is inferred from the regulatory pathway. The RWE signal tool is explicitly unvalidated and can produce unrelated matches, including uses of “registry” that do not indicate the intended research signal. Live FDA-side changes can affect lookup results; the project includes offline tests and optional live tests for known fixtures.