# Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens
> **Food and Drug Administration** · Final amendment; final order. · Published 2024-08-16 · Effective 2024-08-16 · 89 FR 66552
## Document
- **Document number:** 2024-18266
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 89 FR 66552
- **CFR reference:** 21 CFR 866
- **Publication date:** 2024-08-16
- **Effective date:** 2024-08-16
- **HHS docket:** Docket No. FDA-2024-N-3655
## Abstract

The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test 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 device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test'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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2024/08/16/2024-18266/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-and)
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