fda-mcp by rdwj - MCP Server

FDA MCP Server

An MCP (Model Context Protocol) server that provides FDA medical device verification capabilities for prior authorization workflows. Queries the FDA 510(k) database to verify device clearance status and make PA approval decisions.

Features

Device Search: Search FDA 510(k) database by K-number, device name, manufacturer, or product code
Fuzzy Matching: Intelligent fuzzy search with confidence scoring when exact identifiers aren't available
PA Verification: Analyze FDA search results and make prior authorization approval decisions
Confidence Scoring: Each result includes confidence scores based on match quality
OpenShift Deployment: Production-ready deployment to Red Hat OpenShift

Tools

`search_fda_device`

Unified FDA search tool that accepts any combination of identifiers or descriptive information.

Parameters:

device_identifiers (optional): FDA identifiers (k_number, pma_number, product_code, udi)
device_description (optional): Device info for fuzzy search (device_name, manufacturer)
search_options (optional): Search options (fuzzy_search, max_results)

Search Strategies (in priority order):

K-number exact match (confidence: 1.0)
Product code + fuzzy name (confidence: 0.75-0.9)
Fuzzy name/manufacturer search (confidence: 0.5-0.6)

Example:

# Exact K-number search
result = await client.call_tool("search_fda_device", {
    "device_identifiers": {"k_number": "K223677"}
})

# Fuzzy search by device name
result = await client.call_tool("search_fda_device", {
    "device_description": {
        "device_name": "Lexie Lumen",
        "manufacturer": "hearX"
    },
    "search_options": {"fuzzy_search": True}
})

# Search by product code (hearing aids)
result = await client.call_tool("search_fda_device", {
    "device_identifiers": {"product_code": "QUH"},  # OTC hearing aids
    "device_description": {"device_name": "hearing aid"}
})

`verify_fda_approval`

Analyze FDA search results and make PA approval decision with structured reasoning.

Parameters:

fda_search_results: Results from search_fda_device tool
pa_requirements (optional): PA requirements (required_device_class, require_otc, require_cleared_or_approved)

Returns:

Approval decision (approve/deny)
Requirements check details
Human-readable reasoning
Action items for next steps

Example:

# First search for the device
search_result = await client.call_tool("search_fda_device", {
    "device_identifiers": {"k_number": "K223677"}
})

# Then verify for PA approval
verification = await client.call_tool("verify_fda_approval", {
    "fda_search_results": search_result["data"]["results"],
    "pa_requirements": {
        "required_device_class": "2",
        "require_otc": True,
        "require_cleared_or_approved": True
    }
})

Quick Start

Local Development

# Install dependencies
make install

# Run locally with STDIO transport
make run-local

# Test with cmcp
cmcp ".venv/bin/python -m src.main" tools/list

Deploy to OpenShift

# One-command deployment
make deploy

# Or deploy to specific project
make deploy PROJECT=davinci-mcp

Product Codes Reference

Common FDA product codes for hearing devices:

Code	Description
QUH	OTC Self-Fitting Air-Conduction Hearing Aid
OSM	Prescription Hearing Aid
LYY	Cochlear Implant System

Response Schema

All tools return structured responses:

{
  "success": true,
  "data": {
    "search_strategy": "identifier",
    "results": [...],
    "result_count": 1
  },
  "warnings": [],
  "confidence": 1.0,
  "metadata": {
    "execution_time_ms": 245,
    "data_source": "FDA 510(k) Database",
    "search_type": "k_number_exact"
  }
}

Environment Variables

MCP_TRANSPORT - Transport type (stdio/http)
MCP_HTTP_HOST - HTTP host (default: 0.0.0.0)
MCP_HTTP_PORT - HTTP port (default: 8080)
MCP_HTTP_PATH - HTTP endpoint path (default: /mcp/)

Related Projects

pa-workflow-simple - Prior authorization workflow system that uses this MCP server
fhir-mcp - FHIR patient data MCP server

License

MIT License - see for details.