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Readme

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.

FDA Data MCP homepage screenshot

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

Hosted HTTP Setup

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

This is still the canonical setup path today for clients that support remote MCP over HTTP directly.

Claude Desktop / Cursor / Windsurf

Add this to your MCP config:

{
  "mcpServers": {
    "fda-data": {
      "url": "https://www.regdatalab.com/mcp",
      "headers": {
        "Authorization": "Bearer YOUR_API_KEY"
      }
    }
  }
}

OpenAI / Generic MCP Clients

Use the same hosted endpoint:

URL: https://www.regdatalab.com/mcp
Auth header: Authorization: Bearer YOUR_API_KEY

VS Code One-Click Install

This uses the existing mcp-remote install pattern so users can connect to the hosted FDA Data MCP endpoint without running the private backend locally.

Thin npm Wrapper

This repo now includes 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

Planned public install command after the first npm publish:

FDA_DATA_API_KEY=YOUR_API_KEY npx -y fda-data-mcp

The wrapper is ready in the repo now, but it is not published to npm yet. Until that first publish happens, the hosted HTTP setup above remains the public install path.

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:

Auth and Pricing

Sign up for an API key at regdatalab.com/signup
Pass the key in the Authorization: Bearer YOUR_API_KEY header
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

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.

fda-data-mcp