← REGULATORY CHANGES
FEDERAL REGISTER · NOTICESeptember 17, 2024NOTICE — NO LEGAL EFFECT

Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices

What this record is not

Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSE—
APPLIES TO · SPEQ TAGDevice
Document type
Notice
Agency
Health and Human Services Department
Published
September 17, 2024
Document number
2024-21074
Docket
FDA-2024-N-3924
ABSTRACT

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The Committee will discuss total product lifecycle considerations for Generative Artificial Intelligence (AI)-enabled devices. The meeting will be open to the public. FDA is establishing a docket for public comment on this topic.

Abstract as published in the Federal Register.

READ THE FULL DOCUMENT

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.

View on federalregister.gov →

That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.

Create a free account