PredicateExtraction

FDA regulatory tools for medical device analysis, predicate extraction, and submission preparation. v5.29.0 adds TICKET-003 Phase 0: PMA Intelligence Module with SSED download, 15-section extraction, and structured cache. v5.28.0 adds TICKET-004: Multi-pathway Pre-Sub support. v5.27.0 completes TICKET-001: Pre-Sub eSTAR/PreSTAR XML.

AI-powered FDA regulatory assistant with 52 commands, 12 agents — NEW v5.29.0: TICKET-003 Phase 0 PMA Intelligence Module with SSED batch download, 15-section extraction engine, PMA data store with manifest caching, and /fda-tools:pma-search command | v5.28.0: TICKET-004 Multi-Pathway Pre-Sub | v5.27.0: Pre-Sub eSTAR/PreSTAR XML | Core features: predicate extraction, substantial equivalence analysis, submission drafting, PMA intelligence, FDA review simulation, safety surveillance, guidance lookup, standards generation, and full eSTAR/PreSTAR export | Agent-based architecture uses installing user's Claude Code access