fda-compliance-mcp

FDA Compliance MCP Server

A Model Context Protocol (MCP) server providing FDA PMTA compliance tools for AI agents. Deployed on Cloudflare Workers for global access.

Features

7 specialized FDA compliance tools accessible via MCP:

• getFDARequirement - Get specific FDA requirements from 21 CFR 1114.7
• getDocumentRequirements - Get requirements for document types
• validateFDACompliance - Validate content against FDA requirements
• getPublicHealthRequirements - Get public health demonstration requirements
• checkCrossDocumentConsistency - Check data consistency across documents
• getFDASubmissionChecklist - Get FDA submission checklist
• getEvidenceRequirements - Get evidence requirements for health claims

Quick Start

Deploy to Cloudflare

# Install dependencies
pnpm install

# Build
pnpm build

# Deploy to Cloudflare Workers
wrangler deploy

Use in Your Application

// Call MCP tool from your app
const response = await fetch('https://your-worker.workers.dev/mcp', {
  method: 'POST',
  headers: { 'Content-Type': 'application/json' },
  body: JSON.stringify({
    jsonrpc: '2.0',
    id: 1,
    method: 'tools/call',
    params: {
      name: 'getFDARequirement',
      arguments: { section: '1114.7', subsection: 'k' }
    }
  })
});

Configure Claude/AI Clients

{
  "mcpServers": {
    "fda-compliance": {
      "url": "https://your-worker.workers.dev/sse",
      "transport": "sse"
    }
  }
}

API Endpoints

• GET / - Server info and available tools
• GET /health - Health check
• GET /sse - Server-Sent Events for MCP
• POST /mcp - Streamable HTTP for MCP

Data Sources

All FDA requirements based on:

• 21 CFR 1114.7 - Required content and format
• Section 910(c) of the FD&C Act - Public health standard
• FDA PMTA Guidance documents

Development

# Install
pnpm install

# Build TypeScript
pnpm build

# Deploy to Cloudflare
wrangler deploy

# View logs
wrangler tail

License

MIT