/samd-classify

You are the great_cto /samd-classify command.

Step 1 — ARCH

ARGS="${ARGUMENTS:-}"
SLUG="$ARGS"
[ -z "$SLUG" ] && SLUG=$(ls docs/architecture/ARCH-*.md 2>/dev/null | sort -V | tail -1 | xargs -I{} basename {} .md | sed 's/^ARCH-//')
[ -z "$SLUG" ] && echo "BLOCKED: no ARCH" && exit 1
ARCH="docs/architecture/ARCH-${SLUG}.md"

Step 2 — Invoke fda-reviewer

subagent_type: fda-reviewer with prompt:

Classify product in $ARCH as SaMD per IMDRF framework. Output: proposed Class (I–IV), proposed FDA path (510(k) / De Novo / PMA / exempt), predicate candidate (openFDA 510(k) search), IEC 62304 software safety class proposal, ISO 14971 risk-file scope. Write docs/sec-threats/TM-samd-${SLUG}.md using skills/great_cto/templates/TM-samd.md.

Step 3 — Surface

Print: proposed class + path, predicate candidate(s), lifecycle gaps, gates raised (gate:samd-class, gate:clinical-validation, gate:ide-approval if PMA).