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The U.S. Food and Drug Administration announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (the Committee). On November 19, 2026, the Committee will meet to discuss and make recommendations on information about the scientific, clinical, and public health dimensions of the use of pathogen-agnostic sequencing as it relates to emergency preparedness and response efforts. The Committee will also discuss opportunities, implementation considerations and potential priorities for future coordination related to this technology. The preparedness use could cover local or national outbreaks and known or unknown pathogens. This meeting is being held to satisfy, in part, a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA).
The FDA is seeking input on the design of these tests and opportunities and challenges associated with their development, including how to establish an agile yet effective and validated bioinformatics system that can account for frequent changes in pathogen genetic sequences.
The meeting will be open to the public and held in-person at the FDA White Oak Campus and virtually. FDA is establishing a docket for public comment. Registration is not required to attend the meeting.
Important Participation Due Dates:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee.
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October 28, 2026: Email CDRH_MDAC@fda.hhs.gov to request to make oral presentations during the public comment session of the meeting.
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November 3, 2026: Submit written comments on the public docket FDA-2026-N-8692 to be reviewed by the Committee prior to the meeting.
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November 12, 2026: Request special accommodations for the meeting.
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November 12, 2026: Submit written comments to the docket for review and consideration by the FDA.
Questions?
If you have questions, contact the Division of Industry and Consumer Education (DICE).
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