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Changelog

All notable changes to the FDA SaMD Classification Board.

[0.1] — 2026-05-29

Added

  • Initial schema (schema/samd-classification-record.schema.json) with hash-chained record shape, FDA pathway enum, lifecycle state machine, and PCCP block per FDA's December 2024 final guidance.
  • Reference verifier (src/verify.mjs) — re-derives canonical-JSON SHA-256, walks the state machine, enforces the PCCP-block-presence rule when lifecycle is PCCP-related, enforces the 510(k)-cleared-requires-k-number rule.
  • Hash builder (src/build-examples.mjs) — recomputes hash fields across all examples after edits.
  • Three worked examples:
    • skinscan-v4-510k-class-ii.json — clean 510(k) Class II lifecycle (Q-Sub → submission → AI/ML interactive review → cleared → marketed). Same K231234 device that appears across the rest of the HealthTech 6-pack.
    • skinscan-v4-3-pccp-trigger.json — post-market PCCP modification triggered by Fitzpatrick V + VI bias-coverage gap detected in the field, linked back to the clinical-bias-cohort-coverage-lab example bundle's gap event.
    • novel-genai-pathology-de-novo.json — generative-AI surgical-pathology drafting device under De Novo with mandatory human-in-the-loop attestation interlock, per-section provenance, refusal-on-ambiguity behavior, and pathologist-override AI Incident Card emission.
  • Cross-spec linkage in linked_records to Agent Cards, Decision Cards, bias-coverage bundles, medical Incident Cards, and FHIR access audit streams.
  • Lifecycle state machine (12 valid states + valid transition map) and PCCP scope/modification/boundary structure per FDA December 2024 final guidance.
  • Standing public-language guardrail respected in README and inline.

Not yet

  • AJV-based JSON Schema validation (currently the verifier checks structural rules; schema-level validation is delegated to consumers).
  • Schema-level enforcement of the relationship between regulatory_pathway.pathway and the corresponding number field (e.g. pathway = 510(k) implies k_number populated once cleared).
  • IMDRF SaMD risk category I–IV mapping table to FDA class I–III equivalents (planned Phase 2).
  • Special Controls catalog for known AI/ML product codes (Phase 2).
  • A canonical example for a Class III PMA — current set covers 510(k), 510(k)+PCCP, and De Novo but not full PMA.