GxPlex

Jurisdiction: US

18 of 86 tracked instruments.

This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.

Status unknown 1 frozen 5 draft 2 final 8 in-force 2

Ordered by the lifecycle the values themselves name.

Subject (as stated) no self-stated subject 4 artificial intelligence 2 software 4 medical devices 2 security 3 manufacturing 2 data integrity 1 quality management 1
+6 more validation 1 cybersecurity 2 electronic records 2 electronic signatures 2 good manufacturing practice 1 computer software 1

Values match by containment: a document stating "information security" appears under "security", because one string contains the other and no mapping between words is applied.

Class (as stated) no self-stated class 14 authority guidance 2 legal act 2

The words a document uses about itself. One that uses none is filed under "no self-stated class" — a fact about the reading, not a kind of document.

Two facets compose at a time.

Showing 18 of 86 instruments. Clear all filters

Jurisdiction: US — 18 instrument(s) — no change has been detected yet, so rows are alphabetical; they order by change date as soon as one is
Instrument Authority Jurisdiction Status Last verified Last changed Source
21 CFR Part 11 US Food and Drug Administration US in force verified 2026-08-01 link (opens in new tab) · retrieved
21 CFR Part 211 US Food and Drug Administration US in force verified 2026-08-01 link (opens in new tab) · retrieved
FDA AI device list US Food and Drug Administration US not yet verified frozen register states no status link (opens in new tab)
FDA AI guidance US Food and Drug Administration US draft — recorded as draft against the primary source verified 2026-07-30 link (opens in new tab) · retrieved
FDA CDRH AI/ML US Food and Drug Administration US draft — recorded as draft against the primary source verified 2026-07-30 link (opens in new tab) · retrieved
FDA CSA US Food and Drug Administration US final verified 2026-07-30 link (opens in new tab) · retrieved
FDA data integrity US Food and Drug Administration US final verified 2026-07-28 link (opens in new tab) · retrieved
FDA device cybersecurity US Food and Drug Administration US not yet verified awaiting link (opens in new tab)
FDA ETP US Food and Drug Administration US not yet verified frozen not a document link (opens in new tab)
FDA guidance agenda US Food and Drug Administration US not yet verified frozen register states no status link (opens in new tab)
FDA Part 11 scope US Food and Drug Administration US final tool-read 2026-07-31 link (opens in new tab) · retrieved
FDA PCCP US Food and Drug Administration US final verified 2026-07-28 link (opens in new tab) · retrieved
FDA process analytical framework US Food and Drug Administration US final tool-read 2026-07-31 link (opens in new tab) · retrieved
FDA software validation US Food and Drug Administration US final tool-read 2026-07-31 link (opens in new tab) · retrieved
NIST agent standards US National Institute of Standards and Technology US not yet verified frozen not a document link (opens in new tab)
NIST AI RMF Playbook US National Institute of Standards and Technology US not yet verified frozen register states no status link (opens in new tab)
NIST CSF 2.0 US National Institute of Standards and Technology US final verified 2026-08-01 link (opens in new tab) · retrieved
NIST SP 800-82 US National Institute of Standards and Technology US final verified 2026-08-01 link (opens in new tab) · retrieved

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