CDRH: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (MDAC)

Meeting Reminder and Materials: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee On September 23, 2026 the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee) will meet in an open session to discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Galleri® test sponsored by GRAIL Inc. The Galleri® test is a prescription-only qualitative, next-generation sequencing (NGS)-based in vitro diagnostic test intended to detect cancer-specific methylation patterns in cell-free DNA isolated from peripheral whole blood. The Galleri® test is intended for screening for the early detection of multiple types of cancer in adults aged 50 years or older. GRAIL Inc. and FDA will present key information related to the PMA application. The meeting is open to the public. Registration is not required to attend the meeting.