US Federal Register - FDA Notices · August 10, 2026

Molecular and Clinical Genetics Panel Advisory Committee Meeting on GRAIL Galleri; Request for Comments

Original title: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-GRAIL, Inc. Galleri

FDA announces public advisory committee meeting and opens docket for comments on GRAIL's Galleri multi-cancer early detection test.

Low obligation Product class Medical Devices & IVD Digital Health & AI United States In vitro diagnosticsClinical evaluationSoftware as a medical device

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA. The meeting will be open to the public. FDA is establishing a docket for public comment.

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Published by US Federal Register - FDA Notices. HealthSignal links to the original document; the summary above is extracted from the source text.