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fda-samd-mcp

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What is fda-samd-mcp?

This tool provides a Model Context Protocol (MCP) interface to navigate complex FDA regulatory requirements for AI/ML-based Software as a Medical Device (SaMD). It automates the mapping of technical development workflows to 510(k), De Novo, and PMA submission frameworks using GMLP standards.

Tech Stack
PythonMedical Devices

Why fda-samd-mcp?

  • • Standardized MCP interface for LLM integration
  • • Covers major FDA pathways including PCCP
  • • MIT licensed for unrestricted commercial use

Limitations

  • • Requires LLM host for full utility
  • • Regulatory landscape changes require manual updates
  • • No official FDA endorsement or certification
5/14/2026
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Competitor Cost
-$1,440
/ year (est. based on Greenlight Guru)
Self-Hosted
$0
/ year
Team Size10 Users
150+
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