FDA Warning Letters MCP Server

An MCP (Model Context Protocol) server that provides AI assistants with access to FDA medical device warning letters, deficiency analysis, and QMSR/ISO 13485 clause mapping.

Features

🔍 Search & Discovery

• Search warning letters by company name, device type, or keywords
• Filter by device class (I, II, III) and year
• Get detailed deficiency lists for any letter

📊 Analytics & Trends

• View warning letter trends over time
• See most common deficiency categories
• Device class distribution analysis

🔗 QMSR/ISO Mapping

• Automatically map deficiencies to QMSR (21 CFR 820) sections
• ISO 13485:2016 clause cross-references
• ISO 14971 risk management connections

📈 Comprehensive Dataset + Live Data

• Seed data: 224 real FDA warning letters (2021-2026) with 1,148 deficiencies, sourced from the Apr 17 2026 corrected snapshot at virtualbackroom.ai/methodology
• Live scraping from FDA.gov with caching for incremental updates
• Force refresh capability

Installation

git clone https://github.com/KoalaTai/fda-warning-letters-mcp.git
cd fda-warning-letters-mcp
npm install
npm run build

Usage with Claude Desktop

Add to your Claude Desktop config file:

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

{
  "mcpServers": {
    "fda-warning-letters": {
      "command": "node",
      "args": ["/path/to/fda-warning-letters-mcp/dist/index.js"]
    }
  }
}

Then restart Claude Desktop.

Available Tools

| Tool | Description | |------|-------------| | search_warning_letters | Search letters by query, device class, year | | get_letter_details | Get full details for a specific company | | map_to_qmsr | Map any deficiency to QMSR/ISO clauses | | get_qmsr_mapping | Get ISO 13485 equivalent for a CFR section | | analyze_trends | Get trends for 30d, 90d, 1y, or all time | | get_statistics | NEW Comprehensive database stats (severity, device class, year breakdown) | | list_companies | NEW List all companies with warning letters | | get_recent_letters | NEW Get most recent warning letters | | explain_cfr_section | NEW Detailed CFR section explanations with occurrence stats | | refresh_data | Force refresh from FDA.gov |

Available Resources

| URI | Description | |-----|-------------| | fda://warning-letters/all | All cached warning letters | | fda://warning-letters/recent | Letters from last 30 days | | fda://deficiencies/summary | Aggregated deficiency analysis | | fda://qmsr/reference | Complete 21 CFR 820 to ISO 13485 mapping |

Example Queries

Once connected to Claude, you can ask:

• "Search for FDA warning letters related to CAPA failures"
• "What are the most common deficiencies in Class III device warning letters?"
• "Map this deficiency to QMSR: Failure to establish design control procedures"
• "Show me warning letter trends for the past year"
• "Find warning letters for companies making surgical instruments"

QMSR Clause Mapping

The server maps deficiencies to these regulatory frameworks:

| Category | QMSR Section | ISO 13485 Clause | |----------|--------------|------------------| | Design Controls | 820.30 | 7.3 | | CAPA | 820.100 | 8.5.2 | | Complaints | 820.198 | 8.2.2 | | Production | 820.70 | 7.5 | | Documents | 820.40/180 | 4.2 | | Purchasing | 820.50 | 7.4 | | Risk Management | — | ISO 14971 |

Scope

FDA Medical Device Warning Letters corpus - covers 21 CFR 820 (QMSR), 21 CFR 807 (Registration), 21 CFR 809 (IVD), FD&C Act adulteration/misbranding, PMA (21 CFR 814), IDE (21 CFR 812), MDR (21 CFR 803). QMSR/ISO 13485 mapping applied where applicable.

Data Sources

• Curated Seed Data: 224 real FDA warning letters (2021-2026) with 1,148 deficiencies
• Source Snapshot: Apr 17 2026 corrected snapshot from virtualbackroom.ai/methodology
• Regulatory Classification: Strict non-overlapping categorization - CAPA = 820.100 only; NCR = 820.90; Complaint Files = 820.198; Design Controls = 820.30
• Coverage: 705 deficiencies with clean short-form CFR references + 443 with full verbose citations (FD&C Act, U.S.C., statutory refs)
• Device Classes: Class I, II, III, and 142 with unknown classification
• Live Updates: FDA.gov scraper for post-snapshot incremental updates

Development

# Install dependencies
npm install

# Build TypeScript
npm run build

# Run in development mode
npm run dev

# Type check
npm run typecheck

# Run tests
npm test

Testing the Server

# Test MCP handshake
echo '{"jsonrpc":"2.0","id":1,"method":"initialize","params":{"protocolVersion":"2024-11-05","capabilities":{},"clientInfo":{"name":"test","version":"1.0"}}}' | node dist/index.js

# List tools
echo '{"jsonrpc":"2.0","id":1,"method":"tools/list","params":{}}' | node dist/index.js

Project Structure

fda-warning-letters-mcp/
├── src/
│   ├── index.ts        # Main MCP server
│   ├── types.ts        # TypeScript type definitions
│   ├── data.ts         # Warning letter data & scraping
│   └── qmsr-mapping.ts # 21 CFR 820 to ISO 13485 mappings
├── dist/               # Compiled JavaScript
├── package.json
├── tsconfig.json
└── README.md

Contributing

Pull requests welcome! Areas for improvement:

• [ ] Additional warning letter sources
• [ ] More granular QMSR clause mapping
• [ ] Historical trend analysis
• [ ] Full letter content parsing
• [ ] Database persistence

Changelog

v3.0.0 (Apr 2026)

• Dataset expanded: 13 seed letters -> 224 letters (2021-2026) with 1,148 deficiencies
• Regulatory classification corrected: CAPA = 820.100 only; NCR = 820.90; Complaint Files = 820.198 (strict, non-overlapping)
• New field cfrReferenceFull: Preserves verbose citations (FD&C Act, U.S.C., statutory references) for all deficiencies
• cfrReference now nullable: Null for non-CFR citations (e.g., FD&C Act violations); clean short form when available
• deviceClass now nullable: FDA metadata not always available (142 letters with unknown classification)
• issueDate, subject, letterNumber, letterUrl now nullable: Defensive typing for incomplete FDA metadata
• 4 AI-inferred citations removed: Prior drafts included (implied) citations; removed for rigor
• New statistics fields: shortFormCoverage (% of deficiencies with clean CFR ref), totalUniqueCitations
• Non-820 CFR explanations: explain_cfr_section now handles 807.x, 809.x, 814.x, 812.x, 803.x, 806.x
• Source: Apr 17 2026 corrected snapshot from virtualbackroom.ai/methodology

v2.0.2 (Mar 2026)

• Unlocked maxLetters for full scraping (-1 flag)
• Configurable maxLetters in refresh_data tool

v2.0.0 (Feb 2026)

• Removed fabricated data, added working FDA.gov scraper
• 13 verified high-value seed letters
• QMSR/ISO 13485 auto-mapping

Related Projects

• VirtualBackroom.ai - AI-powered regulatory compliance platform
• QMS.Coach - Quality management consulting
• Model Context Protocol - The MCP specification
• OpenFDA - FDA open data APIs

License

MIT - KoalaT.ai

Built for the medical device quality community.