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FastMCP Server Template

by rdwj
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Python
Hybrid

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):

  1. K-number exact match (confidence: 1.0)

  2. Product code + fuzzy name (confidence: 0.75-0.9)

  3. 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

License

MIT License - see LICENSE for details.

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How are these scores calculated?

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