Galleri Panel Vote Shows What FDA Advisory Committees Do and Do Not Decide

An FDA advisory panel voted on Sept. 23 in favor of GRAIL's Galleri multi-cancer early detection blood test, the company said in a press release. The Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee considered GRAIL's premarket approval (PMA) application for the test as a screening tool for adults aged 50 and older.

According to GRAIL, the 10 voting members voted unanimously in support of the test's safety, six to four in support of its effectiveness, and seven to two with one abstention that its benefits outweigh its risks. GRAIL said it submitted the PMA on Jan. 29, 2026, and that FDA is expected to make a final decision "in the coming months."

The vote was a recommendation, not an approval. GRAIL's own release says the agency "is not bound by the Committee's recommendations." That is how FDA's advisory system is designed.

What a committee is for

FDA's page "Learn About FDA Advisory Committees" says the agency often turns to advisory committees for independent advice when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective. Committees weigh the available evidence and advise on the safety, effectiveness and appropriate use of regulated products. They can meet at any stage of a review, and also after a product is on the market.

The agency is explicit about the limits. FDA advisory committees "are just that, advisory, in nature," the page says, and the advice "does not represent the position of the FDA." FDA "makes the final decisions on all matters that come before the committee." The decision to bring a product before a committee is usually at the discretion of the director of the review division, according to the agency.

The committees operate under the Federal Advisory Committee Act and FDA's own rules in 21 CFR Part 14, and FDA has published guidance on voting procedures and on the open public hearing held at each meeting. Meetings are announced in the Federal Register at least 15 days in advance, with instructions for written and in-person comments from the public.

Who sits on a device panel

FDA has about 30 advisory committees. One of them, the Medical Devices Advisory Committee, has 18 panels. Apart from the Medical Devices Dispute Resolution Panel, which handles contested scientific issues between FDA and companies, the panels advise the commissioner on the safety and effectiveness of medical devices.

Members are typically scientific experts such as physician-researchers, statisticians and engineers, appointed for four-year terms, and most committees also have a consumer representative and an industry representative, FDA says. Temporary members, including patient representatives, can be added for a specific meeting.

What the Galleri meeting covered

Before the vote, FDA put questions to the panel centered on whether the clinical data show the test detects cancers reliably and early enough to justify that language in its marketing, NPR reported in a story published by Georgia Public Broadcasting. The panel heard from GRAIL, FDA officials and the public. NPR reported that the panel recommended Galleri's marketing materials advise continuing other routine cancer screenings and avoid characterizing the test as an "early" detection tool.

Speakers disagreed. Phil Castle, director of the National Cancer Institute's Division of Cancer Prevention, told the panel that "Routine approval and broad population rollout would risk harm and waste resources," according to NPR. GRAIL chief executive Josh Ofman said in the company's release that "Today's vote reinforces the strength of Galleri's clinical evidence."

NPR reported that there was no indication at the meeting of when FDA could decide on the application.