Data / Federal rules / 2024-21616
Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management
The Food and Drug Administration published this final rule in the Federal Register on September 23, 2024. It took effect on October 23, 2024.
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What the agency says
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a postamendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification.
Key facts
- Document number
- 2024-21616
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 23, 2024
- Takes effect
- October 23, 2024
- Dates
- This order is effective October 23, 2024.
- Docket
- Docket No. FDA-2016-N-2880
- Code of Federal Regulations
- 21 CFR 866
- Topics
- Biologics; Laboratories; Medical devices
- Pages
- 4
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on biologics · Rules on laboratories · 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.