Data / Federal rules / 2024-20254
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-Free Nucleic Acids
The Food and Drug Administration published this final rule in the Federal Register on September 9, 2024. It took effect on September 9, 2024.
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What the agency says
The Food and Drug Administration (FDA, Agency, or we) is classifying the blood collection device for cell-free nucleic acids 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 blood collection device for cell-free nucleic acids' 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
- 2024-20254
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 9, 2024
- Takes effect
- September 9, 2024
- Dates
- This order is effective September 9, 2024. The classification was applicable on August 7, 2020.
- Docket
- Docket No. FDA-2024-N-4086
- Code of Federal Regulations
- 21 CFR 862
- Topics
- Medical devices
- Pages
- 3
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.