Data / Federal rules / 2026-16727
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 final rule in the Federal Register on August 17, 2026. It took effect on September 16, 2026.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all postamendments class III (premarket approval) devices, into class II (special controls), subject to premarket notification. FDA is also establishing a new device classification regulation, along with the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of this device type.
Key facts
- Document number
- 2026-16727
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- August 17, 2026
- Takes effect
- September 16, 2026
- Dates
- This order is effective September 16, 2026. See further discussion in section IV, "Implementation Strategy."
- Docket
- Docket No. FDA-2025-N-1243
- Code of Federal Regulations
- 21 CFR 864
- Topics
- Blood; Medical devices; Packaging and containers
- Pages
- 8
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 August 2026
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.