# Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management
> **Food and Drug Administration** · Final amendment; final order. · Published 2024-09-17 · Effective 2024-09-17 · 89 FR 75953
## Document
- **Document number:** 2024-21086
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 89 FR 75953
- **CFR reference:** 21 CFR 866
- **Publication date:** 2024-09-17
- **Effective date:** 2024-09-17
- **HHS docket:** Docket No. FDA-2024-N-4084
## Abstract

The Food and Drug Administration (FDA, Agency, or we) is classifying the quantitative viral nucleic acid test for transplant patient management 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 quantitative viral nucleic acid test for transplant patient management'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/2024/09/17/2024-21086/medical-devices-immunology-and-microbiology-devices-classification-of-the-quantitative-viral-nucleic)
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