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AI-powered tools for FDA medical device regulatory work. Built for regulatory affairs professionals working on 510(k) submissions.
From your terminal:
claude plugin marketplace add andrewlasiter/fda-tools
claude plugin install fda-tools@fda-toolsOr from inside a Claude Code or Claude Desktop session:
/plugin marketplace add andrewlasiter/fda-tools
/plugin install fda-tools@fda-tools
Start a new session after installing to load the plugin.
- Find predicates — Search FDA databases, trace predicate lineage, manually propose predicates, and validate device numbers
- Analyze safety — Pull MAUDE adverse events, recall history, and UDI/GUDID records for any product code or device
- Compare adverse events — Statistical peer comparison with percentile-based classification (EXCELLENT → EXTREME_OUTLIER)
- Competitive intelligence — Market concentration (HHI), top manufacturers, technology trends, and gold standard predicates
- Look up standards — Search FDA Recognized Consensus Standards by product code, standard number, or keyword
- Plan your submission — Get pathway recommendations, generate testing plans, and prepare Pre-Sub packages
- Generate documents — Substantial equivalence tables, submission outlines, regulatory prose drafts for 18 eSTAR sections
- Run calculators — Shelf life (ASTM F1980 accelerated aging), sample size, and sterilization dose calculations
- Assemble for filing — eSTAR-structured packages, import/export eSTAR XML, traceability matrices, consistency checks
- Simulate FDA review — Pre-check your submission against RTA checklists and identify likely deficiencies before filing
- Maintain your data — Gap analysis, automated PDF downloads, predicate extraction, and merge pipeline
- Run it all at once — Full autonomous pipeline from extraction through SE comparison
- Monitor changes — Watch for new clearances, recalls, MAUDE events, and guidance updates
42 commands, 7 autonomous agents, and 712 tests covering every stage of the 510(k) workflow — from predicate research through CDRH Portal submission. Integrates with all 7 openFDA Device API endpoints and bundles Python scripts for batch PDF processing and data pipeline maintenance.
See the full documentation for commands, agents, installation details, and quick start examples.
- Quick Start Guide - Get started in 5 minutes with essential commands and workflows
- Installation Guide - Complete setup instructions, dependencies, and configuration
- Troubleshooting Guide - Common issues and solutions
- Linear Integration - Setup guide for Linear MCP integration and automated issue creation
- FDA Examples - FDA-specific workflow examples (510(k), PMA, MAUDE analysis)
- Orchestrator Architecture - Multi-agent orchestration system architecture
- Changelog - Release history and version updates
- Full Plugin Documentation - Detailed command reference and advanced features
- Installation:
claude plugin install fda-tools@fda-tools - Version: 5.36.0
- Repository: GitHub
- Issues: Report a bug
- License: MIT
MIT