Data / Federal rules / 2025-11793
Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies
The Food and Drug Administration published this final rule in the Federal Register on June 26, 2025. It took effect on June 26, 2025.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is classifying the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies 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 the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of 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.
Key facts
- Document number
- 2025-11793
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- June 26, 2025
- Takes effect
- June 26, 2025
- Dates
- This order is effective June 26, 2025. The classification was applicable on December 21, 2018.
- Docket
- Docket No. FDA-2025-N-1264
- Code of Federal Regulations
- 21 CFR 864
- Topics
- Blood; Medical devices; Packaging and containers
- Pages
- 4
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.