Fda Samd Mcp

io.github.CSOAI-ORGPublished by GitHub account CSOAI-ORGv1.0.11Updated Oct 24, 2026

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

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Overview

AI-generated overview

A local Python MCP server that gives an assistant reference material on the FDA's AI/ML Software as a Medical Device Action Plan and US medical-device review, 1

What you can do
Provides reference content on the FDA AI/ML Software as a Medical Device Action Plan and US medical-device regulatory pathways, including 510(k), PMA and De Novo review routes. The manifest lists no tools, so the exact operations an assistant can call are not documented in the supplied material. It runs as a local process over stdio rather than as a hosted endpoint.
When to use it
Worth considering when an assistant needs background on US FDA medical-device regulation for AI/ML software, such as comparing the 510(k), PMA and De Novo pathways. The supplied material is too thin to confirm what it actually returns, so verify before relying on it.
Requirements
Runs locally as a Python process installed from the fda-samd-mcp package on PyPI, using stdio transport. Desktop only; no web execution. No authentication, environment variables or headers are declared.
Before you install
The description is truncated and no tools, instructions or README are provided, so the scope and accuracy of the content cannot be checked. Treat any regulatory information as reference only, not legal or compliance advice, and confirm against official FDA sources.

Installation

In SourceWeft

  1. Open Fda Samd Mcp in the dashboard and add it to a workspace.
  2. Enable the server for the chats that should use its tools.

Desktop only via STDIO. STDIO servers start a local process, so they need the SourceWeft desktop host.

Other MCP clients

Follow the launch instructions in the repository.

README

[MCP Scorecard: 90/100]

Fda Samd MCP

[MEOK AI Labs] [EU AI Act] [License] [PyPI] mcp-name: io.github.CSOAI-ORG/fda-samd-mcp

FDA AI/ML SaMD Compliance MCP

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[PyPI] [License: MIT] [MEOK AI Labs]

FDA AI/ML SaMD compliance MCP

FDA AI/ML SaMD compliance MCP. 510(k), De Novo, PMA, PCCP, GMLP. MIT

🚀 Quick Start

bash
# Install via pippip install fda_samd_mcp
# Or install via Smitherynpx -y @smithery/cli@latest install fda-samd-mcp --client claude

✨ Features

  • MCP protocol compliant
  • Easy installation
  • Well-documented API
  • Production-ready
  • Active maintenance

📖 Documentation

🛡️ Compliance

This MCP server is built with EU AI Act compliance built-in:

  • Free: 10 calls/day. No API key required.

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  • ✅ Article 9 — Risk Management System

  • ✅ Article 13 — Transparency & Instructions for Use

  • ✅ Article 15 — Bias Detection & Testing

  • ✅ Article 26 — FRIA Support (where applicable)

  • ✅ Article 50 — AI Content Watermarking (where applicable)

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🤝 Part of the MEOK Ecosystem

This server is part of the MEOK AI Labs ecosystem — 300+ MCP servers for sovereign AI governance.

DomainPurpose
councilof.aiEU AI Act compliance marketplace
safetyof.aiAI safety & monitoring
meok.aiSovereign AI platform
cobolbridge.aiLegacy modernization

📜 License

MIT © CSOAI-ORG

Built with 💜 by MEOK AI Labs · UK Companies House 16939677

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TierPriceWhat you getStripe
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Configuration

Add to your claude_desktop_config.json (Claude Desktop) or your MCP client config:

json
{  "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).

Examples

Once configured, ask your assistant, for example:

  • "Use classify_sw_device to …"
  • "Use regulatory_pathway to …"
  • "Use pccp_template to …"

Source: README.md at commit b3bf5e6

Tools

0
SourceWeft has not started this package in its sandbox yet, so its tools are not known.

Version history

1
  1. v1.0.11LatestSep 16, 2026

Score

50% of the applicable checks met

How complete this listing is, computed from the registry entry, the endpoint and public sources. Not a rating of the server and not a statement that it is safe or working today: reachability is a dated check, and no installs or reviews go into the score.

  • Reached in the last 30 days25 pts

    Keep the endpoint answering the MCP handshake; SourceWeft probes it every 30 days.

  • Auth declared10 pts

    Declare the credential headers in the registry entry, or keep the endpoint answering the probe so its auth can be classified.

  • Tools listed15 pts

    Answer tools/list without a credential, or ship a package that starts in a sandbox without one.

  • DescriptionRequired15 pts
  • Logo10 pts
  • Documentation15 pts
  • License10 pts