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FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedTech
npx @getmcp/cli add io.github.CSOAI-ORG/fda-samd-mcpRequires Python 3.10+. Community-contributed server. Review source before installing.
Config file: ~/Library/Application Support/Claude/claude_desktop_config.json
{
"mcpServers": {
"io.github.CSOAI-ORG/fda-samd-mcp": {
"command": "uvx",
"args": [
"fda-samd-mcp"
]
}
}
}