GxPlex

Verification: verified · Jurisdiction: US

9 of 86 tracked instruments.

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

Verification ● verified 9 (active — select again to clear) ◐ tool-read 3 · awaiting 1 ▨ frozen 5
Jurisdiction International 21 EU 6 US 9 (active — select again to clear) UK 1 Canada 1 China 1

Ordered by count, then alphabetically.

Two facets compose at a time; the other groups return when one is cleared.

Showing 9 of 86 instruments. Clear all filters

Verification: verified · Jurisdiction: US — 9 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 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 PCCP US Food and Drug Administration US final verified 2026-07-28 — link (opens in new tab) · retrieved
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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