mcpdirectory.dev
9,129 servers · updated 23 Sept

Openfda MCP server

official from Blackswancausallabs Active last commit 47 d
{
  "mcpServers": {
    "blackswancausallabs-openfda": {
      "command": "uvx",
      "args": [
        "openfda-mcp"
      ],
      "env": {
        "OPENFDA_API_KEY": "<openfda_api_key>"
      }
    }
  }
}
file .mcp.json (in your project root)install uvx openfda-mcpversion 0.1.0

What it does

This server resolves FDA application numbers and product names to regulatory metadata for drugs, biologics, and medical devices through the openFDA API. It is designed for developers working with real-world evidence datasets who need to map FDA identifiers to authoritative product and device information.

  • Look up drug or biologic regulatory records by NDA/BLA/ANDA application number or product name.
  • Resolve medical device submission numbers (K, DEN, P, H numbers) to device class and medical specialty.
  • Search drug label text for specific content or scan labels for real-world evidence signals.

Tools this server exposes

ToolDoes
search_drug_labelSearch SPL label text, optionally scoped to a specific section.
lookup_drugsfda_applicationRetrieve Drugs@FDA record for an NDA/BLA/ANDA number.
resolve_drug_to_applicationConvert brand or generic drug name to one or more application numbers.
screen_for_rwe_signalsExperimental tool to sweep drug labels for real-world evidence signals.
lookup_device_submissionRetrieve device record from a K, DEN, P, or H submission number.
classify_device_product_codeMap product code to device class and medical specialty.
validate_device_applicationResolve device submission number through full chain to class, specialty, and category.

Before you enable it

An MCP server runs with whatever access you give it. Start with a development account rather than production, and check which tools the server exposes before you let an agent call them unattended.