GxPlex

Jurisdiction: US · Class (as stated): no self-stated class

14 of 86 tracked instruments.

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Class (as stated) no self-stated class 14 (active — select again to clear) authority guidance 2 legal act 2

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Showing 14 of 86 instruments. Clear all filters

Jurisdiction: US · Class (as stated): no self-stated class — 14 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
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 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

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