21 CFR 876.5450
§ 876.5450 Rectal dilator.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.5450, § 876.5450 Rectal dilator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90344
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ys:prov:90344@1- SHA-256
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Full text
(a) Identification. A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.
(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 § 876.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.