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FDA SaMD Compliance

Verified Integration
Author: @CSOAI-ORG•Category: ServerApplication•MIT
GitHub Repository
JSON-RPC 2.0
Protocol Standard
Sub-second
Execution Latency
Active
Operational Status
Tags:#Claude#Search#Database#API#Git#AI#GitHub#Node.js#Automation

Client Configuration

— Connect FDA SaMD Compliance to Claude Desktop or Cursor in seconds
{
  "mcpServers": {
    "fda-samd-compliance": {
      "command": "npx",
      "args": [
        "-y",
        "@modelcontextprotocol/server-fda-samd-compliance"
      ],
      "env": {}
    }
  }
}
Paste into ~/Library/Application Support/Claude/claude_desktop_config.json (macOS) or %APPDATA%\Claude\claude_desktop_config.json (Windows).
Architecture & Capabilities

System Overview

Automate compliance for AI/ML-driven Software as a Medical Device (SaMD) under FDA regulations, supporting various regulatory pathways.

Indexed Date

7/23/2026

License

MIT

Protocol Layer

stdio / SSE RPC

Frequently Asked Questions

Architecture and operational details for FDA SaMD Compliance

The tool provides comprehensive support for various FDA regulatory pathways, including 510(k), De Novo, PMA (Premarket Approval), PCCP (Pre-submission Communication Coordination Plan), and GMLP (Good Machine Learning Practice).

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