CSOAI   Home · Fabric · Standards · Certification
Regulatory & Compliance · MCP fabric · v1.0.8

FDA SaMD MCP

FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedT...

Install in 60 seconds

pip install fda-samd-mcp

Or one-click from the official MCP Registry · source: github.com/CSOAI-ORG/fda-samd-mcp · MIT licence · namespace io.github.CSOAI-ORG

Pricing

Free tier: 10 calls/day. Pro £199/mo — unlimited calls + Ed25519-signed attestations + public verify URLs (subscribe). Starter £29/mo · Enterprise £1,499/mo. Every tier gets x402 pay-as-you-go per call.

Certified by CSOAI

This server is part of the CSOAI governance fabric — 290+ servers in the official MCP Registry (verified 2026-06-10). The standard behind it is published in the Crosswalk Library; runtime results on commercial tiers are signed and independently verifiable at /verify. CSOAI certifies; MEOK AI Labs builds; the certifier is not the vendor.

Get Watchdog CertifiedBrowse the fabric

EU AI Act Article 50 hits new generative systems on 2 August 2026 — the £999 Article 50 Kit makes you ready.