Click on "Install Server".
Wait a few minutes for the server to deploy. Once ready, it will show a "Started" state.
In the chat, type @ followed by the MCP server name and your instructions, e.g., "@FDA AI/ML SaMD Compliance MCP Classify my AI-powered diagnostic tool as a SaMD and determine its regulatory pathway."
That's it! The server will respond to your query, and you can continue using it as needed.
Here is a step-by-step guide with screenshots.
mcp-name: io.github.CSOAI-ORG/fda-samd-mcp
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FDA AI/ML SaMD compliance MCP
FDA AI/ML SaMD compliance MCP. 510(k), De Novo, PMA, PCCP, GMLP. MIT
Related MCP server: IEC 62304 Requirements MCP Server
# Install via pip
pip install fda_samd_mcp
# Or install via Smithery
npx -y @smithery/cli@latest install fda-samd-mcp --client claudeMCP protocol compliant
Easy installation
Well-documented API
Production-ready
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Domain | Purpose |
EU AI Act compliance marketplace | |
AI safety & monitoring | |
Sovereign AI platform | |
Legacy modernization |
MIT Ā© CSOAI-ORG
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Smoke test | Ā£1 | Signed sample MCP-Hardening report + Article 50 PDF | |
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Add to your claude_desktop_config.json (Claude Desktop) or your MCP client config:
{
"mcpServers": {
"fda-samd-mcp": {
"command": "uvx",
"args": ["fda-samd-mcp"]
}
}
}Or: pip install fda-samd-mcp then run the fda-samd-mcp command (stdio transport).
Once configured, ask your assistant, for example:
"Use classify_sw_device to ā¦"
"Use regulatory_pathway to ā¦"
"Use pccp_template to ā¦"
This server cannot be installed
Unclaimed servers have limited discoverability.
If you are the server author, to access and configure the admin panel.
FDA and CMS evidence for AI medical devices: 510(k), postmarket, reimbursement, and compliance.
Multi-jurisdictional AI compliance readiness scoring with sourced penalty math.
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