An open-source alternative to high-cost regulatory consultants for FDA 510(k) submissions. It utilizes a multi-agent Claude-based pipeline to automate predicate device extraction, gap analysis, and eSTAR assembly.
Tech Stack
PythonMedical Devices
Why fda-predicate-assistant?
• Automates tedious regulatory documentation
• Integrates directly with Claude Code CLI
• Provides structured gap analysis for eSTAR
Limitations
• Requires LLM API token costs
• Output requires expert human verification
• Limited to 510(k) regulatory pathway
2/17/2026
Last Update
0
Forks
1
Issues
Unknown
License
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