Limits of this record
These are limits of this record, not of the documents it tracks. A regulator's guidance is no less in force because this archive cannot retrieve it.
Every count below is generated from the corpus. A reader who needs certainty about any instrument should consult its primary source, which is linked from the instrument's own page.
The observation series
- 7 days since the first observation, on . No claim about stability beyond that age is supportable from this record.
- 621 instrument-days observed across 104 sources. An instrument-day is one source observed on one date; the loop may run more than once in a day, and the raw series holds 4,255 rows. The tracker itself covers 86 instruments — the observed-source count is higher because records for instruments since removed from scope are retained rather than deleted.
- Largest gap in the series: 1 day(s) after . Gaps are retained and never backfilled — an interpolated observation is a measurement nobody made.
No public document exists (6)
A committee, programme or organisational unit rather than a document. There is nothing with a status to record.
- CEN/CLC JTC 21 — CEN/CENELEC
- FDA ETP — US Food and Drug Administration
- ISO/IEC SC 42 — ISO/IEC
- ISPE Pharma 4.0 — International Society for Pharmaceutical Engineering
- MHRA AI Airlock — Medicines and Healthcare products Regulatory Agency
- NIST agent standards — US National Institute of Standards and Technology
Paywalled — progression tracked only (17)
The text is not public by licence. Stage or step metadata published by the body itself is tracked instead; the text is never reproduced.
- ASTM E2537 — ASTM International
- IEC 62304 — ISO/IEC
- IEC 62443 — IEC / ISA
- ISO 13485 — ISO/IEC
- ISO 14971 — ISO/IEC
- ISO/IEC 27001 — ISO/IEC
- ISO/IEC 27002 — ISO/IEC
- ISO/IEC 27017 — ISO/IEC
- ISO/IEC 27018 — ISO/IEC
- GAMP AI Guide — ISPE
- GAMP 5 2nd Ed — ISPE
- PIC/S GMP Guide — Pharmaceutical Inspection Co-operation Scheme
- PIC/S PI 041 — Pharmaceutical Inspection Co-operation Scheme
- prEN 18229-1 — CEN/CENELEC JTC 21
- prEN 18229-2 — CEN/CENELEC JTC 21
- prEN 18281 — CEN/CENELEC JTC 21
- prEN 18282 — CEN/CENELEC JTC 21
Source refuses automated requests (3)
The publisher returns a non-200 response, or drops the connection, to both agent profiles used here.
- IMDRF AI/ML WG — International Medical Device Regulators Forum
- IMDRF SaMD — International Medical Device Regulators Forum
- TGA SaMD — Therapeutic Goods Administration
Only a listing exists (7)
The source covers several documents and no page describing this one on its own has been found. A status read from a listing may describe a different document.
- ANVISA — Agência Nacional de Vigilância Sanitária
- DI revision concept paper — European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme
- PIC/S Annex 11 — Pharmaceutical Inspection Co-operation Scheme
- PMDA AI — Pharmaceuticals and Medical Devices Agency
- Swissmedic — Swissmedic
- WHO data management — World Health Organization
- WHO computerised systems — World Health Organization
A register, which has no status (3)
A published list or agenda: a snapshot of a population, reissued rather than amended. The document is retrieved and hashed, so revisions are observable — but a register is not draft, final or in-force, so no status is recorded. This is not an absent document. Follow the link and read it.
- FDA AI device list — US Food and Drug Administration
- FDA guidance agenda — US Food and Drug Administration
- NIST AI RMF Playbook — US National Institute of Standards and Technology
Awaiting verification (6)
A public document exists and its status has not yet been checked against it by a person. These are the entries a reader should treat as least settled.
- Annex 11 concept paper — European Medicines Agency
- Annex 15 revision concept paper — European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme
- EU GMP Annex 22 — European Commission
- FDA device cybersecurity — US Food and Drug Administration
- FDA/EMA AI principles — US Food and Drug Administration and European Medicines Agency
- NIST AI RMF — US National Institute of Standards and Technology
Corrections
53 correction(s) recorded, of which 0 were reported by a reader.
No reader has submitted a correction. A site that has only ever corrected itself has been checked by one party. Readers are recorded as "reported by a reader" and never named.
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