RegDataLab – FDA Compliance Data

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

The hosted endpoint is https://www.regdatalab.com/mcp. Pick the first path your client supports:

1. OAuth sign-in (claude.ai, Claude Desktop, ChatGPT custom MCP servers, other OAuth-capable clients): add the bare URL and sign in. No key in your config.
2. Authorization header (Claude Code, Cursor, Windsurf, the OpenAI API, scripts): send Authorization: Bearer YOUR_API_KEY.
3. npx wrapper (stdio-only clients such as claude_desktop_config.json): set FDA_DATA_API_KEY.

Never put an API key in a URL. URLs end up in server, proxy and browser logs. The canonical, current client steps are in the connect guide.

claude.ai, Claude Desktop and Claude Cowork

1. Open Settings > Connectors and add a custom connector.
2. Enter only https://www.regdatalab.com/mcp.
3. Choose sign in, paste your RegDataLab API key on the RegDataLab consent page and approve read-only access.

ChatGPT

Add RegDataLab manually as a custom MCP server: in ChatGPT, open Plugins, choose +, then Add custom MCP server, enter only https://www.regdatalab.com/mcp and sign in (OpenAI's older docs call this a custom connector under Apps). Availability depends on your ChatGPT plan and workspace settings; the connect guide has the current steps. A RegDataLab directory listing has been submitted to OpenAI and is in review; it is not published, so it cannot be installed from the directory yet.

Claude Code

claude mcp add fda-data https://www.regdatalab.com/mcp \

--transport http \ --header "Authorization: Bearer YOUR_API_KEY" \ --scope user

Verify with /mcp. You should see fda-data and the manufacturing-first toolset.

Cursor

Add to ~/.cursor/mcp.json (or .cursor/mcp.json in a project you do not commit):

{

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

Windsurf

Add to ~/.codeium/windsurf/mcp_config.json:

{

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

OpenAI API (Responses)

from openai import OpenAI

client = OpenAI() response = client.responses.create( model="gpt-4.1", tools=[{ "type": "mcp", "server_label": "fda-data", "server_url": "https://www.regdatalab.com/mcp", "require_approval": "never", # tools are read-only "headers": {"Authorization": "Bearer YOUR_API_KEY"}, }], input="Give me a manufacturing risk summary for Pfizer", ) print(response.output_text)

VS Code One-Click Install

Generic MCP clients

• URL: https://www.regdatalab.com/mcp (Streamable HTTP)
• Auth: OAuth 2.1 with PKCE and dynamic client registration, or the header Authorization: Bearer YOUR_API_KEY
• Discovery file: https://www.regdatalab.com/.well-known/mcp.json

npx wrapper (stdio-only clients)

For clients that can only start a local command, such as claude_desktop_config.json:

{

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

Config file location:

• macOS: ~/Library/Application Support/Claude/claude_desktop_config.json
• Windows: %APPDATA%\Claude\claude_desktop_config.json

Or from a shell: FDA_DATA_API_KEY=YOUR_API_KEY npx -y fda-data-mcp

The wrapper is a zero-dependency stdio-to-HTTP proxy:

• source: bin/fda-data-mcp.js
• proxy: lib/stdio-proxy.js

The version on npm can lag this repo; see CHANGELOG.md for what each published version contains.

If you do not have an API key yet, sign up at regdatalab.com/signup. A new key starts with 50 credits; verifying your email unlocks 300 free credits a 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
• MES, QMS and LIMS software vendor evidence (software_* tools)

For the canonical and current product surface, use:

• Docs
• API page

Auth and Pricing

• Sign up for an API key at regdatalab.com/signup
• OAuth-capable clients: add the bare URL and sign in; no key in your config
• Other HTTP clients: send the Authorization: Bearer YOUR_API_KEY header
• The npx wrapper: set FDA_DATA_API_KEY=YOUR_API_KEY
• Never put a key in a URL or in an issue report
• 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: hello@regdatalab.com

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.