Fda Samd Mcp
Map FDA AI/ML SaMD expectations and 510(k), PMA, or De Novo options while scoping a US medical software product.
Overview
fda-samd-mcp is an MCP server for the Validate phase that helps solo builders explore FDA AI/ML SaMD planning and 510(k), PMA, and De Novo pathway context inside their coding agent.
What is this MCP server?
- Covers FDA AI/ML Software as a Medical Device Action Plan context for agent-assisted planning
- Surfaces 510(k), PMA, and De Novo pathway framing for US MedTech software
- Stdio MCP transport (fda-samd-mcp on PyPI, server version 1.0.3)
- Keeps regulatory research inside the coding agent instead of scattered bookmark tabs
- Pairs with validation-phase specs before hardware- or clinic-coupled builds
- Server schema version 1.0.3
- Single PyPI package identifier fda-samd-mcp with stdio transport
- Documented pathways: 510(k), PMA, De Novo, plus AI/ML SaMD Action Plan framing
What problem does it solve?
MedTech founders waste weeks in generic web search trying to guess which FDA pathway fits their AI software before they have a scoped regulatory plan.
Who is it for?
Indie builders and small teams scoping AI-enabled diagnostic, triage, or clinical workflow software aimed at the US market.
Skip if: Teams that already have a regulatory consultant, cleared device, or products with zero SaMD risk profile.
What do I get? / Deliverables
After you register fda-samd-mcp, your agent can ground scope and roadmap chats in SaMD action-plan themes and named US submission routes instead of vague compliance anxiety.
- Agent-grounded SaMD and pathway terminology for validation docs
- Scoped regulatory questions list for counsel or clinical partners
- Submission-route comparison notes tied to your MVP feature set
Recommended MCP Servers
Journey fit
How it compares
Regulatory-pathway MCP integration, not a QMS platform or a substitute for FDA submission filing software.
Common Questions / FAQ
Who is fda-samd-mcp for?
It is for solo builders and small MedTech teams who need agent-accessible FDA SaMD and 510(k)/PMA/De Novo pathway context during early product scoping.
When should I use fda-samd-mcp?
Use it during Validate when you are deciding device intent, claims, and submission strategy—not as a post-launch afterthought.
How do I add fda-samd-mcp to my agent?
Install the PyPI package fda-samd-mcp (1.0.3), configure stdio MCP in Claude Code or Cursor, and point the server entry at io.github.CSOAI-ORG/fda-samd-mcp.