21 CFR § 866.3950 - In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.

---
identifier: "/us/cfr/t21/s866.3950"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3950 - In vitro human immunodeficiency virus (HIV) drug resistance genotype assay."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3950"
section_name: "In vitro human immunodeficiency virus (HIV) drug resistance genotype assay."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.

(a) *Identification.* The in vitro HIV drug resistance genotype assay is a device that consists of nucleic acid reagent primers and probes together with software for predicting drug resistance/susceptibility based on results obtained with these primers and probes. It is intended for use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs, as an aid in monitoring and treating HIV infection.

(b) *Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.” See § 866.1(e) for the availability of this guidance document.

[72 FR 44382, Aug. 8, 2007]