Data / Federal rules / 2024-20999
Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System
The Food and Drug Administration published this final rule in the Federal Register on September 16, 2024. It took effect on September 16, 2024.
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What the agency says
The Food and Drug Administration (FDA, Agency, or we) is classifying the pediatric continuous renal replacement therapy 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 pediatric continuous renal replacement therapy 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
- 2024-20999
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 16, 2024
- Takes effect
- September 16, 2024
- Dates
- This order is effective September 16, 2024. The classification was applicable on April 29, 2020.
- Docket
- Docket No. FDA-2024-N-4082
- Code of Federal Regulations
- 21 CFR 876
- Topics
- Medical devices
- Pages
- 5
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · 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.