Data / Federal rules / 2025-21071
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
The Food and Drug Administration published this proposed rule in the Federal Register on November 25, 2025. Comments closed on January 26, 2026.
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What the agency says
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.
Key facts
- Document number
- 2025-21071
- Type
- Proposed rule
- Action
- Proposed amendment; proposed order; request for comments
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- November 25, 2025
- Comments due
- January 26, 2026
- Dates
- Submit electronic or written comments on the proposed order by January 26, 2026. Please see section X of this document for the proposed effective date when the new requirements apply and for the proposed effective date of a final order based on this proposed order.
- Docket
- Docket No. FDA-2025-N-4622
- Code of Federal Regulations
- 21 CFR 866
- Topics
- Biologics; Laboratories; Medical devices
- Pages
- 14
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on biologics · Rules on laboratories · Rules on medical devices · Published in November 2025
Read from the Federal Register API, last updated 2026-10-24. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.