21 CFR 888.4300
§ 888.4300 Depth gauge for clinical use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.4300, § 888.4300 Depth gauge for clinical use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91139
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Full text
(a) Identification. A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.
(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 § 888.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.