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skill

us-sleep-regulatory

Agent skill for US FDA 510(k)/De Novo, SaMD, AI/ML, QMSR, and HIPAA/FTC research for app-based sleep therapy. Local-first SQLite knowledge base, openFDA/eCFR/FR retrieval, and cited memos. Works with

allbegray/us-sleep-regulatorycommunitylistedunreviewed

Listed with a link only — no licence

The repository states no licence, so by default nobody may reuse it. We only link to it. Setup instructions and the README are on the project's own page.
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