Fda Samd Mcp

Gives Claude direct access to FDA regulatory pathways for AI/ML medical devices. Exposes tools for software classification, 510(k) pathway selection, De Novo submissions, PMA routes, and PCCP (Predetermined Change Control Plan) templates aligned with FDA's AI/ML SaMD Action Plan. You'd use this when navigating US medical device regulatory strategy, checking which submission track applies to your ML diagnostic or treatment software, or generating compliant documentation templates. Built by MEOK AI Labs with a focus on EU AI Act alignment as well. Free tier runs 10 calls per day over stdio, paid tiers add signed attestations for audit trails.