# RegDataLab
> Manufacturing-first FDA intelligence for AI agents, with broader company, facility, approval, recall, shortage, safety, and specialty coverage behind one MCP endpoint.

## Start Here
- Start with `fda_manufacturing_risk_summary` for company-level manufacturing and compliance due diligence.
- Use `fda_facility_dossier` when you already know the FEI and want the local compliance story fast.
- Use `fda_company_compliance_timeline` when you want one reverse-chronological event stream across inspections, warning letters, import risk, debarments, and recalls.

## Connect
- https://www.regdatalab.com/connect.md
- Header auth (primary) for native HTTP clients: send `Authorization: Bearer YOUR_API_KEY`
- Browser connectors (claude.ai custom connector) that cannot set a header: paste `https://www.regdatalab.com/mcp?apiKey=YOUR_KEY` — query-param auth is honored only on the `/mcp` endpoint, and the key rides in the URL, so treat it like a password
- Native HTTP option for Claude Code: `claude mcp add fda-data https://www.regdatalab.com/mcp --transport http --header "Authorization: Bearer YOUR_API_KEY"`
- Local stdio wrapper for Claude Desktop / Cowork, Cursor, or Windsurf: `FDA_DATA_API_KEY=YOUR_API_KEY npx -y fda-data-mcp`

## Documentation
- https://www.regdatalab.com/docs
- https://www.regdatalab.com/api

## Data Sources
- https://www.regdatalab.com/datasets

## Live Statistics Dashboards
- https://www.regdatalab.com/stats/recalls — FDA recall statistics (Class I/II/III, companies, trends)
- https://www.regdatalab.com/stats/inspections — FDA inspection statistics (OAI/VAI/NAI)
- https://www.regdatalab.com/stats/510k — FDA 510(k) clearance statistics
- https://www.regdatalab.com/stats/compliance — FDA warning letter & compliance statistics
- https://www.regdatalab.com/stats/shortages — FDA drug shortage statistics

## Full Tool Reference
- https://www.regdatalab.com/llms-full.txt