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  • FDA AI-DSF lifecycle guidance: DRAFT (Jan 2025) — not for implementation
  • PCCP guidance: final (Dec 2024, updated Aug 2025)
  • FDA Statistical Guidance on diagnostic tests: final (2007)
  • Guidance map v1

Changelog

Two repositories, two version strings. The engine is proofpack (public); the site is proofpack-site. Every date below is the author date of a commit in the repository named, read from git log on 15 September 2026; a build day that ran on a different calendar day than its plan carries the date it was actually committed. Neither repository has a release tag yet, and no version 1.0.0 of anything exists.

Version string in the package: 0.1.0.dev1 (src/proofpack/__init__.py). No wheel has been published to any index and no container image has been pushed. pip install proofpack on the install page is the shipping interface, not a live command.

Date (commit) Build day What landed
2026-09-07 init Repository created.
2026-09-07 E1 Validated ingest and declarations: schema_v1.json, criteria_schema.json, the egress and claims schema skeletons, io.schema, io.declare, the header-only mapper, HALT gates H01–H12, doctor, the CLI (doctor, map, run, compare).
2026-09-07 E2 Proportions: Wilson and Clopper-Pearson intervals, Newcombe unpaired and paired differences, the two-by-two metrics, PPV and NPV at a declared prevalence, the indeterminate both-ways tables.
2026-09-07 E3 Discrimination: Mann–Whitney AUROC, DeLong variance with Wald and logit intervals, paired and unpaired DeLong comparisons, the ROC curve and operating-point location.
2026-09-07 hardening Number frozen; every build-day marker run in CI; the [unverified] markings protected by a test.
2026-09-07 to 2026-09-08 E4 and its repairs Bootstrap and the clustered path; the seven day-4 verification defects and the cluster-plan fixes that followed.
2026-09-15 E5 and its repairs stats.subgroups: per-level metrics, differences, fairness gaps, the heterogeneity footnote; two repair rounds refusing the heterogeneity test on clustered rows and a clustered difference with a frozen arm.

Not yet in the engine, and described on these pages as not yet in it: the statistics and templates behind run (run stops after ingest and the HALT gates), proofpack declare, proofpack fixtures, proofpack licence, the telemetry module, the test-set ledger, the T12 renderer, the interactive mapper, the DOCX/HTML/JSON renderers.

Version string in package.json: 0.1.0. The site is not deployed; the deploy is scheduled for 30 September 2026.

Date (commit) Build day What landed
2026-09-07 S1 Site shell: nav, status strip, footer, home, scope, legal placeholders, robots, llms.txt, sitemap, schema, the Starlight docs route.
2026-09-07 S2 Pricing, card checkout, the licence issuer.
2026-09-07 S3 Quote → invoice flow.
2026-09-07 S7 Trust cluster: the egress table generated from the engine’s schema; the validation page that cannot overstate.
2026-09-07 to 2026-09-08 day-4 repairs, rounds 1–7 The claim scanners, the legal and key gates and the money path repaired round by round against fresh-attack lenses.
2026-09-11 to 2026-09-15 day-4 repair round 8 The legal gate reads what a browser draws; the money path’s list-price collision; the claim scanners read HTML through one tokeniser walk.
2026-09-15 S9 This docs hub: install, quickstart, criteria.yaml, schema and mapping, HALT gates, version comparison, egress and --offline, billing, T12 IQ/OQ, scope, support, changelog; the stable-anchor registry; forced light; the status strip and footer on the docs; the Ask-the-docs box (markup only); /how-it-works.

A pack’s T8 manifest records the engine version and the guidance-map version it was rendered with, and the header-set hash of the table. When the engine version changes, the fixture register is re-run and its report is republished on the validation page; a change to any frozen expected value is explained here, on this page, not silently re-frozen.