# 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
> **Food and Drug Administration** · Final amendment; final order. · Published 2025-08-21 · Effective 2025-08-21 · 90 FR 40709
## Document
- **Document number:** 2025-16034
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 90 FR 40709
- **CFR reference:** 21 CFR 866
- **Publication date:** 2025-08-21
- **Effective date:** 2025-08-21
- **HHS docket:** Docket No. FDA-2025-N-2788
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2025/08/21/2025-16034/medical-devices-immunology-and-microbiology-devices-classification-of-a-multiplex-respiratory-panel)
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