How Does FDA Classify Drug Test Devices?

FDA classifies most drug of abuse test systems as class II devices under 21 CFR Part 862, and most are exempt from 510(k) premarket notification only when intended for employment or insurance testing and within the limits in 21 CFR 862.9. Breath alcohol test systems are class I (21 CFR 862.3050).

Device types by drug. Classification regulations in 21 CFR Part 862, subpart D, include these drug test systems:

Class II with limits. For these class II test systems, the regulation states that the device is not exempt if it is intended for any use other than employment or insurance testing (21 CFR Part 862). The exemption also requires a statement in the labeling that the device is intended solely for use in employment and insurance testing (21 CFR 862.3100 through 862.3870). A device is also not exempt if it has a different intended use or uses a different fundamental scientific technology than a legally marketed device of the same type (21 CFR 862.9).

Breath alcohol. A breath alcohol test system measures alcohol in human breath. It is class I under general controls and exempt from 510(k), subject to 862.9 (21 CFR 862.3050).

Federal programs. FDA's October 2026 order extended the exemptions to devices intended for federal drug testing programs (Federal Register 2026-20448).

Workplace panels. The drugs on a test panel depend on the program. The FAQ on what a non-DOT drug test screens for covers common panels, and the FAQ on urine drug screens explains the specimen type.

Recent change. The FAQ on FDA's 510(k) exemption for federal drug tests explains the October 2026 order.