Cuts 510(k) submission drafting from 200 hours to 60 hours (70% savings). Generates predicate comparisons and substantial equivalence narratives.
FDA 510(k) premarket notification submission helper covering 21 CFR Part 807. Drafts indications-for-use statements, substantial equivalence comparisons, predicate device tables, performance testing summaries, and RTA checklist responses. Estimated time savings: 140 hours per submission.