21 CFR 868.6225
§ 868.6225 Nose clip.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.6225, § 868.6225 Nose clip, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89855
- Permanent ID
ys:prov:89855@1- SHA-256
56fe2adce464708f13e01c0cb5772e833be7c18046ab5d86fe4b58bdffb4c3bc
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 nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures.
(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 § 868.9. The device is also 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.