FDA's Microbiology Devices Panel of the Medical Devices Advisory Committee meets virtually and in open session — , 9 a.m.–4 p.m. ET — to discuss pathogen-agnostic sequencing, the technology that reads whatever genetic material is present in a clinical sample rather than testing for one suspected organism at a time, and its role in emergency preparedness and response.

Dates and format

  • Date: 19 November 2026, 9 a.m.–4 p.m. ET, open session
  • Format: fully virtual, open to the public
  • Docket: FDA-2026-N-8692, established for public comment
  • Organizer: FDA Center for Devices and Radiological Health, Medical Devices Advisory Committee — Microbiology Devices Panel

What it covers

Pathogen-agnostic sequencing scans a clinical sample's genetic material broadly, rather than testing against a shortlist of suspected pathogens, which makes it a candidate tool for catching a novel or unexpected outbreak organism before a targeted test would even be ordered. The Panel takes up the scientific, clinical and public-health dimensions of using it for emergency preparedness and response, and discusses opportunities, implementation considerations and priorities for coordinating it across the public health system — work the meeting is held in part to satisfy under the Food and Drug Omnibus Reform Act of 2022.

Who should attend

Regulatory and clinical affairs leads on molecular diagnostics and infectious-disease IVD programs, public-health laboratory and emergency-preparedness teams evaluating sequencing-based surveillance, and anyone tracking how FDA plans to fold pathogen-agnostic methods into its regulatory framework. The session is free, fully virtual and open to the public.

The same committee structure votes on GRAIL's Galleri multi-cancer test in September, and the full events directory lists everything we have verified.

Frequently asked questions

When is the FDA Microbiology Devices Panel meeting on pathogen-agnostic sequencing?

19 November 2026, 9 a.m. to 4 p.m. Eastern Time, held fully virtually and open to the public.

What is the Committee discussing?

The scientific, clinical, and public health dimensions of pathogen-agnostic sequencing as a tool for emergency preparedness and response, along with opportunities, implementation considerations and priorities for future coordination. The session is held in part to satisfy a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA).

Can the public comment?

Yes. FDA established public docket FDA-2026-N-8692 for written comment on this meeting.

Is there a fee to attend?

No stated fee. FDA advisory committee meetings are free and open to the public, and this session is fully virtual.

Sources & further reading

  1. Federal Register / FDA. Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments — Pathogen-Agnostic Sequencing, 09/16/2026. federalregister.gov

Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of the Federal Register notice rather than a direct fetch, because this session's network egress could not reach federalregister.gov or fda.gov directly — confirm dates and access with FDA before making plans. Last verified 16 September 2026.