An independent, dated record of what regulators published, and when it changed
Every tracked document is fetched, normalised and hashed on a daily schedule. The hash is recorded whether or not anything changed — because "unchanged for 412 days" is only a fact if all 412 observations exist.
| Days of continuous observation | Instruments | Observations recorded | Revisions detected | Silent revisions |
|---|---|---|---|---|
| 0 | 0 | 0 | 0 | 0 |
A silent revision is a document whose content changed with no version or date declared alongside it. Detecting one requires having hashed the document before it changed. Since .
Detected revisions · Findings, each with its method · Which sources are machine-readable · Snapshots and hashes · How this is done
What this is not
It reports what documents say and when they changed. It contains no interpretation, no recommendations, and no assessment of what any document requires of any organisation. Read the primary source and take your own professional advice.
Current status of tracked instruments
A view of the archive, not the product. Status is recorded only after a person has checked it against the primary source.
35 of 35 statuses are not yet verified. They are listed so coverage is visible. Observation of those documents is already running — verification and observation are independent.
EU (11)
| Instrument | Authority | Status | Last changed | Last verified | Source |
|---|---|---|---|---|---|
| EASA AI | European Union Aviation Safety Agency | not yet verified | — | — | link |
| EMA QIG | European Medicines Agency | not yet verified | — | — | link |
| EU AI Act | European Parliament and Council | not yet verified | — | — | link |
| EU GMP Annex 11 | European Commission | not yet verified | — | — | link |
| EU GMP Annex 22 | European Commission | not yet verified | — | — | link |
| EU IVDR | European Parliament and Council | not yet verified | — | — | link |
| EU MDR | European Parliament and Council | not yet verified | — | — | link |
| prEN 18229-1 | CEN/CENELEC JTC 21 | not yet verified | — | — | link |
| prEN 18229-2 | CEN/CENELEC JTC 21 | not yet verified | — | — | link |
| prEN 18281 | CEN/CENELEC JTC 21 | not yet verified | — | — | link |
| prEN 18282 | CEN/CENELEC JTC 21 | not yet verified | — | — | link |
US (6)
| Instrument | Authority | Status | Last changed | Last verified | Source |
|---|---|---|---|---|---|
| 21 CFR Part 11 | US Food and Drug Administration | not yet verified | — | — | link |
| FDA AI guidance | US Food and Drug Administration | not yet verified | — | — | link |
| FDA CDRH AI/ML | US Food and Drug Administration | not yet verified | — | — | link |
| FDA CSA | US Food and Drug Administration | not yet verified | — | — | link |
| FDA ETP | US Food and Drug Administration | not yet verified | — | — | link |
| FDA guidance agenda | US Food and Drug Administration | not yet verified | — | — | link |
International (13)
| Instrument | Authority | Status | Last changed | Last verified | Source |
|---|---|---|---|---|---|
| GAMP 5 2nd Ed | ISPE | not yet verified | — | — | link |
| GAMP AI Guide | ISPE | not yet verified | — | — | link |
| ICH Q12 | International Council for Harmonisation | not yet verified | — | — | link |
| ICH Q13 | International Council for Harmonisation | not yet verified | — | — | link |
| ICH Q14 | International Council for Harmonisation | not yet verified | — | — | link |
| ICH Q2(R2) | International Council for Harmonisation | not yet verified | — | — | link |
| ICH Q9(R1) | International Council for Harmonisation | not yet verified | — | — | link |
| IMDRF SaMD | International Medical Device Regulators Forum | not yet verified | — | — | link |
| ISO/IEC 23894 | ISO/IEC | not yet verified | — | — | link |
| ISO/IEC 42001 | ISO/IEC | not yet verified | — | — | link |
| NIST AI RMF | US National Institute of Standards and Technology | not yet verified | — | — | link |
| PIC/S GMP Guide | Pharmaceutical Inspection Co-operation Scheme | not yet verified | — | — | link |
| UNECE WP.29 | United Nations Economic Commission for Europe | not yet verified | — | — | link |
UK (1)
Other (4)
| Instrument | Authority | Status | Last changed | Last verified | Source |
|---|---|---|---|---|---|
| Health Canada ML | Health Canada | not yet verified | — | — | link |
| PMDA AI | Pharmaceuticals and Medical Devices Agency | not yet verified | — | — | link |
| Swissmedic | Swissmedic | not yet verified | — | — | link |
| TGA SaMD | Therapeutic Goods Administration | not yet verified | — | — | link |
Machine-readable
/api/observations.json ·
/api/revisions.json ·
/api/findings.json ·
/api/crawlability.json ·
/api/instruments.json ·
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