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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR866.3950]
See Related Information on In vitro human immunodeficiency virus (HIV) drug resistance genotype assay. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES

Subpart D--Serological Reagents

Sec. 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]

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