Data / Federal rules / 2025-10549
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
The Food and Drug Administration published this proposed rule in the Federal Register on June 11, 2025. Comments closed on August 11, 2025.
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What the agency says
The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) 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 this device type.
Key facts
- Document number
- 2025-10549
- Type
- Proposed rule
- Action
- Proposed amendment; proposed order; request for comments
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- June 11, 2025
- Comments due
- August 11, 2025
- Dates
- Either electronic or written comments on the proposed order must be submitted by August 11, 2025. 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-1243
- Code of Federal Regulations
- 21 CFR 864
- Topics
- Blood; Medical devices; Packaging and containers
- Pages
- 10
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on blood · Rules on medical devices · Rules on packaging and containers · Published in June 2025
Read from the Federal Register API, last updated 2026-10-23. 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.