September 23, 2026: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement September 23, 2026

Advisory Committee Meeting | In Person

---

• Date: September 23, 2026
• Time: 9:00 a.m. - 6:00 p.m. ET

---

What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

Webcast Information:

YouTube:

https://youtube.com/live/83XzLN7Dbg4 

Center	Date	Time	Location
CDRH	September 23, 2026	9:00 a.m. - 6:00 p.m.	FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.1503), Silver Spring, MD 20993-0002

SUMMARY:

The Food and Drug Administration (FDA) announces a forthcoming hybrid (in-person and virtual) 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 the FDA.

On September 23, 2026, 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. The test is also intended to predict where a detected cancer signal may have originated in the body and should be followed by a diagnostic workup by a qualified health care professional. The meeting will be open to the public. The FDA is establishing a docket for public comment.

DATES:

The meeting will be held in-person and virtually on September 23, 2026, from 9 a.m. to 6:00 p.m. ET. 

ADDRESSES:

Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings. 

PUBLIC COMMENT:

The FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2026-N-8004. The docket will close on September 16, 2026. Please note that late, untimely filed comments will not be considered.

The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 16, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Comments received on or before September 8, 2026, will be provided to the Committee. Comments received after that date will be taken into consideration by the FDA. In the event that the meeting is cancelled, the FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.

---

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

---

Contact