GxPlex

FDA CDRH AI/ML

FDA guidance on AI-enabled device software functions

not yet verified

Last verified: not yet verified Last observed: no observation recorded Tier: 1 · Sector: medical device

Not yet verified. The status of this instrument has not been confirmed against its primary source. It is recorded as unknown rather than estimated. Consult the primary source (opens in new tab) directly.

Authority
US Food and Drug Administration
Jurisdiction
US
Status
not yet verified
Effective date
—
Last changed
—
Last verified
: not yet verified
Watch cadence
monthly
Crawlable
unknown
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) fda.gov

Current status#

Status not yet verified against the primary source. Recorded as unknown rather than estimated.

Scope#

FDA guidance addressing artificial-intelligence-enabled device software functions and predetermined change control plans.

Sources#

NEEDS VERIFICATION. The regulatory status of this instrument has not yet been confirmed against its primary source. It is recorded as unknown rather than estimated. See /methodology for what verification means here.

Cite this instrument

Each format carries the permalink and the date this instrument was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. FDA guidance on AI-enabled device software functions [instrument record]. Observed 28 July 2026. https://gxplex.com/instrument/fda-cdrh-aiml Primary source: https://www.fda.gov/medical-devices/software-medical-device-samd

BibTeX

@misc{gxplexinstrumentfdacdrhaiml,
  author       = {{GxPlex}},
  title        = {{FDA guidance on AI-enabled device software functions}},
  year         = {2026},
  note         = {instrument record, observed 28 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/fda-cdrh-aiml}},
  urldate      = {2026-07-29},
  url          = {https://www.fda.gov/medical-devices/software-medical-device-samd}
}

APA

GxPlex. (2026). FDA guidance on AI-enabled device software functions [instrument record]. Retrieved 28 July 2026, from https://gxplex.com/instrument/fda-cdrh-aiml

Observation history

No observations recorded yet.

Archived versions

Change history

Sources