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fda-tools

The premium Open Source alternative to Greenlight Guru

🎯 Best for:Medical device developers looking to accelerate FDA regulatory submissions using LLMs.
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What is fda-tools?

An AI-powered alternative to manual regulatory assembly for medical devices. Automates 510(k) submissions using Claude Code agents to handle gap analysis, predicate extraction, and eSTAR assembly.

Tech Stack
PythonAI, ML & Data

Why fda-tools?

  • • Automates tedious eSTAR assembly
  • • Advanced predicate extraction
  • • Simulates FDA reviews

Limitations

  • • Requires Claude Code access
  • • AI output requires validation
  • • Complex regulatory domain
2/26/2026
Last Update
0
Forks
200
Issues
Unknown
License
Financial Leak Detected

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Competitor Cost
-$1,440
/ year (est. based on Greenlight Guru)
Self-Hosted
$0
/ year
Team Size10 Users
150+
Launch Detailed Calculator
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