Data / Federal rules / 2025-16034
Medical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens
The Food and Drug Administration published this final rule in the Federal Register on August 21, 2025. It took effect on August 21, 2025.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is classifying the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens 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 classification of the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens. We are taking this action because we have determined that classifying the device into class II 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
- 2025-16034
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- August 21, 2025
- Takes effect
- August 21, 2025
- Dates
- This order is effective August 21, 2025. The classification was applicable on November 24, 2017.
- Docket
- Docket No. FDA-2025-N-2788
- Code of Federal Regulations
- 21 CFR 866
- Topics
- Biologics; Laboratories; Medical devices
- Pages
- 5
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 August 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.