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fda-predicate-assistant-plugin

The premium Open Source alternative to Greenlight Guru

🎯 Best for:MedTech regulatory teams automating 510(k) documentation
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What is fda-predicate-assistant-plugin?

A specialized Claude Code plugin that automates the assembly of FDA 510(k) eSTAR files and predicate device extraction. It utilizes four specialized AI agents to simulate FDA review processes and ensure regulatory alignment.

Tech Stack
PythonLegal & Compliance

Why fda-predicate-assistant-plugin?

  • • Automated eSTAR assembly
  • • Predicate extraction logic
  • • CLI-integrated workflow

Limitations

  • • Requires Claude Code
  • • High domain knowledge needed
  • • CLI-only interface
2/8/2026
Last Update
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Forks
0
Issues
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License
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Competitor Cost
-$1,440
/ year (est. based on Greenlight Guru)
Self-Hosted
$0
/ year
Team Size10 Users
150+
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