FDA Panel Probes Mystery Pathogen Sequencing for Next Pandemic
Published Date: 9/16/2026
Notice
Summary
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.
No Economic Impacts Identified for this Document
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-18946, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
2026-18612, Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cardiovascular machine learning- based notification software. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2026-18529, Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking
The FDA wants your thoughts on how they collect info to track medical devices. This affects companies that make or handle these devices and aims to keep things safe and clear. You’ve got until November 10, 2026, to share your comments—no cost, just your voice!
Previous / Next Documents
Previous: 2026-18919, Privacy Act of 1974; System of Records
In accordance with the Privacy Act of 1974, the OSD is providing notice to rescind a system of records (SORN) titled "Commercial Travel Information Management System (CTIM)," DHRA 14 DoD. The CTIM was established as a repository to collect, maintain, and use DoD travel records from both the Defense Travel System (DTS) and commercial travel vendors. This centralized system is used to satisfy reporting requirements, ensure traveler safety, assist in resource planning, detect fraud, and provide customer support for all DoD official travel-related services.
Next: 2026-18921, Certain Cold-Drawn Mechanical Tubing of Carbon and Alloy Steel From Italy: Final Results of Antidumping Duty Administrative Review; 2024-2025
The U.S. Department of Commerce (Commerce) determines that Dalmine S.p.A. (Dalmine) made sales of subject merchandise at prices below normal value (NV) during the period of review (POR). The POR is June 1, 2024, through May 31, 2025.