21 CFR § 862.3360 - Drug metabolizing enzyme genotyping system.

---
identifier: "/us/cfr/t21/s862.3360"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3360 - Drug metabolizing enzyme genotyping system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3360"
section_name: "Drug metabolizing enzyme genotyping system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY 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: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.3360 Drug metabolizing enzyme genotyping system.

(a) *Identification.* A drug metabolizing enzyme genotyping system is a device intended for use in testing deoxyribonucleic acid (DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information.

(b) *Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping Test System.” See § 862.1(d) for the availability of this guidance document.

[70 FR 11867, Mar. 10, 2005]