FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedT...
90/100 A+ · ranked #30 of 339 MEOK MCPs · v1.0.5 · 7 tools
fda-samd-mcp scores 90/100 on the proofof.ai 100-point rubric — flagship-grade (top tier).
That is above the fleet average of 85. Install: pip install fda-samd-mcp.
| Category | Score | |
|---|---|---|
| README | 10/10 | |
| Tool design | 10/10 | |
| Examples | 10/10 | |
| Tests + CI | 10/10 | |
| Transports | 5/10 | |
| Metadata | 10/10 | |
| Reliability | 8/10 | |
| Security | 10/10 | |
| Docs surface | 7/10 | |
| Provenance/Revenue | 10/10 |
Framework: fastmcp · transport: stdio. Tools: classify_sw_device, regulatory_pathway, pccp_template, good_ml_practice, ai_ml_action_plan, search_regulation, list_regulations_in_db.
pip install fda-samd-mcpMCP client config: add {"command":"uvx","args":["fda-samd-mcp"]} under mcpServers.