fda-catalyst-devices

> Methodology inspired by publicly taught medtech catalyst frameworks; all text is an original paraphrase. ## Defaults | Parameter | Default Value | Rationale | |-----------|---------------|-----------| | forward_window_quarters | 4 | Standard catalyst window; extend to 8 on request | | include_superseded | false | Active-only events by default; supersede chains on request | | coverage_lens | true | Coverage and NTAP milestones tracked alongside decision events | | recall_scan | true | Recalls and watch actions surfaced as risk signals by default | | holiday_labeling | true | Holiday-shifted weeks flagged on every calendar row | ## Preflight Run canonical pre-flight per `contracts/preflight.md`. Include the `X-Agentii-Trace` header on every tool call per `contracts/x-agentii-trace-header.md` — carry the `_run_id` from your first tool result and name yourself (and your parent, if you were spawned). Confirm ticker resolution via `search_companies` before catalyst queries. ## Triggers - "What device decisions (510(k)/PMA/De Novo) are coming up for [ticker]?" - "When is the PMA decision date for [device/ticker]?" - "Which medtech names have device decisions this quarter?" - "What coverage or NTAP milestones are pending for [ticker]?" - "Has [ticker] had any recalls or watch-list actions recently?" - "Build a device catalyst calendar for my medtech watchlist." - "How do De Novo classifications differ from 510(k) as catalysts?" - "Evaluate the approval odds for [device] ahead...