November 19, 2026: Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement November 19, 2026

Advisory Committee Meeting | In Person

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• Date: November 19, 2026
• Time: 9:00 a.m. - 4:00 p.m. ET

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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/pUjANlAc1ZQ 

Center	Date	Time	Location
CDRH	November 19, 2026	9:00 a.m. - 4:00 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 Microbiology Devices 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 November 19, 2026, the Committee will meet to discuss and make recommendations to FDA on examining the scientific, clinical, and public health dimensions of the use of pathogen-agnostic sequencing as it relates to emergency preparedness and response efforts, and to support discussion of opportunities, implementation considerations, and potential priorities for future coordination. The preparedness use could cover local outbreaks, national outbreaks, known pathogens, 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 the opportunities and challenges associated with their development, including how to establish an agile but effective and validated bioinformatics system that can account for frequent sequence changes. 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 November 19, 2026, from 9 a.m. to 4:00 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-8692. The docket will close on November 12, 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 November 12, 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 November 3, 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. 

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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.

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

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