21 CFR 874.1500
§ 874.1500 Gustometer.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 874.1500, § 874.1500 Gustometer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90200
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Full text
(a) Identification. A gustometer is a battery-powered device that consists of two electrodes that are intended to be placed on both sides of the tongue at different taste centers and that provides a galvanic stimulus resulting in taste sensation. It is used for assessing the sense of taste.
(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 § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.