FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedTech
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uvx fda-samd-mcpAdd this server entry to the mcpServers object in your Claude Desktop config, then restart the app.
{
"mcpServers": {
"io-github-csoai-org-fda-samd-mcp": {
"command": "uvx",
"args": [
"fda-samd-mcp"
]
}
}
}~/Library/Application Support/Claude/claude_desktop_config.json%APPDATA%\Claude\claude_desktop_config.jsonNo remote HTTP endpoint is advertised. Use the package or stdio setup shown in Install.
fda-samd-mcp is an MCP server for FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedTech. It supports STDIO transport.
Use the generated config in Install. This server runs with uvx fda-samd-mcp; add any required environment variables before starting your client.
Choose the Claude Desktop tab in Install and copy the config for uvx fda-samd-mcp. Add required environment variables before starting Claude Desktop.
Choose the Claude Code tab in Install and copy the config for uvx fda-samd-mcp. Add required environment variables before starting Claude Code.
Choose the Codex tab in Install and copy the config for uvx fda-samd-mcp. Add required environment variables before starting Codex.
Choose the Cursor or VS Code tab in Install and copy the config for uvx fda-samd-mcp. Add required environment variables before starting Cursor or VS Code.
fda-samd-mcp uses STDIO transport. Use the package or command config in Install.
fda-samd-mcp inventory is listed when the MCP endpoint exposes tools, resources, or prompts. Some servers require auth first.
fda-samd-mcp does not advertise a verified auth requirement. If discovery fails, it may still need provider login, an API key, a bearer token, or a session header.
| Package | Registry | Version | Inputs |
|---|---|---|---|
fda-samd-mcpstdio | pypi | 1.0.3 | None advertised |