21 CFR 862.3050
§ 862.3050 Breath-alcohol test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.3050, § 862.3050 Breath-alcohol test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89245
- Permanent ID
ys:prov:89245@1- SHA-256
ce1d29c3854b5d00155cb9cfe8ab071cc0e613e19bdb30ba564a3ca9d37cf2bf
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.