GxPlex

Subject (as stated): software · Class (as stated): no self-stated class

8 of 86 tracked instruments.

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

Class (as stated) no self-stated class 8 (active — select again to clear) consensus standard 1

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; the other groups return when one is cleared.

Showing 8 of 86 instruments. Clear all filters

Subject (as stated): software · Class (as stated): no self-stated class — 8 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 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 PCCP US Food and Drug Administration US final verified 2026-07-28 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
IMDRF SaMD International Medical Device Regulators Forum International not yet verified frozen blocks automated requests link (opens in new tab)
MHRA AI Medicines and Healthcare products Regulatory Agency UK final verified 2026-07-30 link (opens in new tab) · retrieved
Swissmedic Swissmedic Switzerland not yet verified frozen listing only link (opens in new tab)
TGA SaMD Therapeutic Goods Administration Australia not yet verified frozen blocks automated requests link (opens in new tab)

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