fda-samd-mcp 1.0.3

FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedTech and digital health firms.

FDA AI/ML SaMD Compliance MCP

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Free tier remains MIT-licensed and zero-config. Upgrade only when you need signed compliance artefacts for audit.

FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedTech and digital health firms.

Install

pip install fda-samd-mcp

Tools

Tool	Purpose
classify_sw_device	FDA SaMD vs SiMD classification + IMDRF risk framework
regulatory_pathway	510(k) / De Novo / PMA pathway selection
pccp_template	Predetermined Change Control Plan generator (locked vs adaptive AI)
good_ml_practice	FDA Good Machine Learning Practice (GMLP) 10 principles
ai_ml_action_plan	FDA AI/ML Action Plan focus area assessment

Pairs with

• meok-attestation-api — POST results to https://meok-attestation-api.vercel.app/sign for cryptographically signed compliance certs
• meok-attestation-verify — public verification of any MEOK-signed cert
• Other MEOK governance MCPs via SOV3 mcp_bridge_call

Pricing

• Free: 10 calls/day. No API key required.
• Pro £79/mo: unlimited + signed attestations. Subscribe
• Enterprise £1,499/mo: white-label + on-premise + SLA. [e-mail]

Status

Scaffold v1.0.0 ships the MCP framework + 5 tool stubs. v1.1.0 will add real regulation data ingestion.

If your team needs this MCP fully-loaded faster, ping [e-mail] for sponsored development.

License

MIT © MEOK AI Labs