Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments
Abstract
The Food and Drug Administration (FDA) is proposing to reclassify certain postamendments class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product (product codes OWD, PJG, PQP, and SFL) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.
Federal Register Source
This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.
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Frequently Asked Questions
What is the 2025-21071 Federal Register document?
Document 2025-21071 is a Proposed Rule published by the Food and Drug Administration in the Federal Register on November 25, 2025. The Food and Drug Administration (FDA) is proposing to reclassify certain postamendments class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product (product codes OWD, PJG, PQP, and SFL) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. View the original at https://www.federalregister.gov/documents/2025/11/25/2025-21071/immunology-and-microbiology-devices-reclassification-of-nucleic-acid-based-test-systems-for-use-with.
Is document 2025-21071 an economically significant rule?
No. Document 2025-21071 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.