# 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.

[![Website](https://img.shields.io/badge/website-regdatalab.com-0f172a?style=flat-square)](https://www.regdatalab.com)
[![Connect Guide](https://img.shields.io/badge/docs-connect.md-0369a1?style=flat-square)](https://www.regdatalab.com/connect.md)
[![Release](https://img.shields.io/github/v/release/medley/fda-data-mcp?display_name=tag&style=flat-square)](https://github.com/medley/fda-data-mcp/releases)

![FDA Data MCP homepage screenshot](./assets/fda-data-mcp-homepage.png)

## Quick Links

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

### 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](https://www.regdatalab.com/connect.md) 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

```bash
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):

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

### Windsurf

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

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

### OpenAI API (Responses)

```python
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

[![Install in VS Code](https://img.shields.io/badge/VS_Code-Install_MCP-0098FF?style=flat-square&logo=visualstudiocode&logoColor=white)](https://insiders.vscode.dev/redirect/mcp/install?name=fda-data-mcp&inputs=%5B%7B%22password%22%3Atrue%2C%22id%22%3A%22fda-data-api-key%22%2C%22type%22%3A%22promptString%22%2C%22description%22%3A%22FDA%20Data%20MCP%20API%20key%20%28from%20regdatalab.com/signup%29%22%7D%5D&config=%7B%22command%22%3A%22npx%22%2C%22args%22%3A%5B%22-y%22%2C%22fda-data-mcp%22%5D%2C%22env%22%3A%7B%22FDA_DATA_API_KEY%22%3A%22%24%7Binput%3Afda-data-api-key%7D%22%7D%7D)

### 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`:

```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`](./bin/fda-data-mcp.js)
- proxy: [`lib/stdio-proxy.js`](./lib/stdio-proxy.js)

The version on npm can lag this repo; see [CHANGELOG.md](./CHANGELOG.md) for what each published version contains.

If you do not have an API key yet, sign up at [regdatalab.com/signup](https://www.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](https://www.regdatalab.com/docs)
- [API page](https://www.regdatalab.com/api)

## Auth and Pricing

- Sign up for an API key at [regdatalab.com/signup](https://www.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](https://www.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](https://www.regdatalab.com/docs)
- Connect: [regdatalab.com/connect.md](https://www.regdatalab.com/connect.md)
- Email: [hello@regdatalab.com](mailto:hello@regdatalab.com)

## Changelog and Releases

- Version history lives in [CHANGELOG.md](./CHANGELOG.md)
- Public release notes live on the [GitHub releases page](https://github.com/medley/fda-data-mcp/releases)

## Security

If you find a security issue, do not open a public issue. Use the policy in [SECURITY.md](./SECURITY.md).