# Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Nucleic Acids From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s)
> **Food and Drug Administration** · Final amendment; final order. · Published 2025-05-09 · Effective 2025-05-09 · 90 FR 19631
## Document
- **Document number:** 2025-08149
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 90 FR 19631
- **CFR reference:** 21 CFR 866
- **Publication date:** 2025-05-09
- **Effective date:** 2025-05-09
- **HHS docket:** Docket No. FDA-2025-N-0814
## Abstract

The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) 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 nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s)'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, in part by reducing regulatory burdens.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2025/05/09/2025-08149/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-nucleic)
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