FDA Data MCP

Hosted MCP server for FDA regulatory, manufacturing, and compliance intelligence.

This is the public install and discovery repo for FDA Data MCP. The live MCP endpoint is hosted at RegDataLab. The private backend, ingestion system, and production data pipeline are not open-sourced here.

Quick Links

• Website: regdatalab.com
• MCP endpoint: https://www.regdatalab.com/mcp
• Discovery metadata: https://www.regdatalab.com/.well-known/mcp.json
• Connect guide: regdatalab.com/connect.md
• Product docs: regdatalab.com/docs
• Pricing: regdatalab.com/pricing
• Signup: regdatalab.com/signup
• Changelog: CHANGELOG.md
• Releases: github.com/medley/fda-data-mcp/releases
• Wrapper package source: package.json

What It Does

FDA Data MCP gives AI agents structured access to FDA data for questions like:

• Which facilities does this company operate?
• Has FDA inspected them recently?
• Were those inspections NAI, VAI, or OAI?
• Are there recalls, enforcement actions, or import refusals?
• What does FDA show for 510(k), PMA, Drugs@FDA, NDC, and related regulatory records?

The strongest current use case is manufacturing and compliance intelligence for pharma, biotech, and medtech teams.

Quick Start

Claude Desktop / Cowork

FDA_DATA_API_KEY=YOUR_API_KEY npx -y fda-data-mcp

This is the best default path today for:

• Claude Desktop
• Cowork
• Cursor
• Windsurf
• other stdio MCP clients

Cowork uses the MCPs you already connected in Claude Desktop, so if Desktop is configured, Cowork can use the same FDA Data MCP connection.

Claude Desktop config

Add this to your MCP config:

{
  "mcpServers": {
    "fda-data": {
      "command": "npx",
      "args": ["-y", "fda-data-mcp"],
      "env": {
        "FDA_DATA_API_KEY": "YOUR_API_KEY"
      }
    }
  }
}

Claude Code / native remote HTTP

claude mcp add fda-data https://www.regdatalab.com/mcp --transport http --header "Authorization: Bearer YOUR_API_KEY"

Use this when you want the hosted MCP directly instead of the wrapper.

OpenAI / generic MCP clients

• URL: https://www.regdatalab.com/mcp
• Auth header: Authorization: Bearer YOUR_API_KEY
• Discovery file: https://www.regdatalab.com/.well-known/mcp.json

VS Code One-Click Install

This uses the hosted MCP endpoint without running the private backend locally.

Thin npm Wrapper

The public wrapper is already published on npm:

FDA_DATA_API_KEY=YOUR_API_KEY npx -y fda-data-mcp

It is a thin stdio wrapper around mcp-remote:

• source: bin/fda-data-mcp.js
• config helper: lib/wrapper-config.js
• package metadata: package.json

Local example from a cloned repo:

FDA_DATA_API_KEY=YOUR_API_KEY node bin/fda-data-mcp.js

If you do not have an API key yet, sign up here:

• regdatalab.com/signup
• includes 300 free credits/month

Example Prompts

• Give me a manufacturing risk summary for Pfizer.
• Show recent VAI and OAI inspections for Moderna.
• Summarize recalls, compliance actions, and import refusals for Thermo Fisher.
• What does FDA have on this company across facilities, inspections, and enforcement?

Data Coverage

FDA Data MCP covers live hosted access to datasets including:

• FDA inspections
• FDA citations
• FDA compliance actions
• FDA import refusals
• recalls and enforcement
• 510(k) clearances
• PMA approvals
• Drugs@FDA
• NDC directory
• drug labels
• device registrations and listings
• device UDI
• drug shortages

For the canonical and current product surface, use:

• Docs
• API page

Auth and Pricing

• Sign up for an API key at regdatalab.com/signup
• Pass the key in the Authorization: Bearer YOUR_API_KEY header
• Or set FDA_DATA_API_KEY=YOUR_API_KEY when using the wrapper
• Free and paid plans are listed at regdatalab.com/pricing

Why This Repo Exists

This repo is intentionally public and lightweight so it can serve as:

• the GitHub landing page for the hosted MCP
• a stable place for setup examples
• a future home for marketplace metadata and install helpers

The production backend and ingestion engine live separately.

Support

• Docs: regdatalab.com/docs
• Connect: regdatalab.com/connect.md
• Email: [email protected]

Changelog and Releases

• Version history lives in CHANGELOG.md
• Public release notes live on the GitHub releases page

Security

If you find a security issue, do not open a public issue. Use the policy in SECURITY.md.