Data / Federal rules / 2024-19824
Medical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test System
The Food and Drug Administration published this final rule in the Federal Register on September 5, 2024. It took effect on September 5, 2024.
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What the agency says
The Food and Drug Administration (FDA or we) is classifying the heparin and direct oral factor Xa inhibitor drug test system 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 heparin and direct oral factor Xa inhibitor drug test system's 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.
Key facts
- Document number
- 2024-19824
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 5, 2024
- Takes effect
- September 5, 2024
- Dates
- This order is effective September 5, 2024. The classification was applicable on September 17, 2020.
- Docket
- Docket No. FDA-2024-N-3971
- Code of Federal Regulations
- 21 CFR 864
- Topics
- Blood; Medical devices; Packaging and containers
- Pages
- 3
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 September 2024
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.