# 2026-16245: FDA Panel to Grill Galleri Multi-Cancer Blood Test Makers

2026-16245, 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, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-08-10, effective 2026-09-23; PRIA reads it as touching household money (as of 2026-08-17).

- Canonical: https://policyrisk.com/federal-register/2026-16245
- As of: 2026-08-17
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-16245
- 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
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 51496
- Published: 2026-08-10
- Effective: 2026-09-23
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-17

## In one line

FDA Panel to Grill Galleri Multi-Cancer Blood Test Makers

## Summary

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.

## Effects PRIA read

- Galleri multi-cancer screening for 50+: benefit, medium. FDA will consider a premarket approval application for the Galleri test on September 23, 2026. The Galleri test is a prescription-only, lab-performed next-generation sequencing (NGS) test intended for screening adults aged 50 years or older for multiple types of cancer; a "Cancer Signal Detected" r…

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## Sources
- [2026-16245 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/10/2026-16245/molecular-and-clinical-genetics-panel-of-the-medical-devices-advisory-committee-notice-of-meeting)
- [2026-16245 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-10/pdf/2026-16245.pdf)

## Related
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- [Next: 2026-16246, Determination of Regulatory Review Period for Purposes of Patent Extension; DAY…](https://policyrisk.com/federal-register/2026-16246)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-16245 (as of 2026-08-17).