# Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay
> **Food and Drug Administration** · Final rule. · Published 2007-08-08 · Effective 2007-09-07 · 72 FR 44380
## Document
- **Document number:** E7-15475
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 72 FR 44380
- **CFR reference:** 21 CFR 866
- **Publication date:** 2007-08-08
- **Effective date:** 2007-09-07
- **HHS docket:** Docket No. 2007N-0294
## Abstract

The Food and Drug Administration (FDA) is classifying an in vitro human immunodeficiency virus (HIV) drug resistance genotype assay into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay." FDA is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2007/08/08/E7-15475/medical-devices-immunology-and-microbiology-devices-classification-of-in-vitro-human)
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