OpenFDA

The OpenFDA MCP Server provides a unified access layer to the U.S. FDA public datasets via the openFDA API. It exposes a set of drug and device search tools that let you query adverse events, drug labels, NDC directory data, recalls, approvals, shortages, and device regulatory information such as 510(k) clearances, classifications, and adverse events. Each tool returns structured JSON with search criteria, total results, and the formatted data payload, making it easy to compose complex queries across FDA domains. If you have an API key from openFDA, you can enable higher rate limits to perform more intensive lookups.

Typical workflow: authenticate (if you have an API key) by supplying FDA_API_KEY as an environment variable in your MCP settings or deployment environment. Then use the exposed tool endpoints to perform targeted searches (for example, adverse events for a specific drug, or 510(k) clearances for a device class). The server handles parameter validation, rate limiting awareness, and returns clean JSON with relevant metadata and results.

Prerequisites:

• Node.js (recommended v14+)
• npm or pnpm
• Optional: FDA API key for higher rate limits

1. Install dependencies (if provided in a repository setup):

npm install

2. Configure environment variables (optional, for higher rate limits):

# Set FDA_API_KEY environment variable for higher rate limits
export FDA_API_KEY="your_api_key_here"

3. Run the MCP server:

# Start the server (adjust to your deployment method and entry point)
node dist/index.js

4. Verify the server is running by hitting the health or root endpoint as documented in your deployment notes. If you need to rebuild from source, ensure TypeScript is compiled to the dist/ directory before starting the server.

Tips and notes:

• If you have an FDA API key, set FDA_API_KEY to increase rate limits (up to 120,000 requests/hour).
• Without an API key, the server adheres to the standard rate limits (around 1,000 requests/hour).
• The server provides modular drug and device tools; new tools can be added by extending the handler modules and updating the registration in the main server file.
• Use the documented search parameters for each tool to filter results efficiently (e.g., date ranges, manufacturer, product type).
• Ensure your deployment environment preserves environment variables (e.g., in container environments, use -e FDA_API_KEY or a corresponding secret store).
• The API response includes search_criteria, total_results, results_shown, a data array (e.g., adverse_events, drug_labels), and api_usage to help with monitoring and debugging.