Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Pathogen-Agnostic Sequencing
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee 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 FDA. In addition, the Committee will meet to discuss and provide advice 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 and 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 meeting will be open to the public. FDA is establishing a docket for public comment.
Abstract as published in the Federal Register.
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