21 CFR 872.5570
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.5570, § 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90151
- Permanent ID
ys:prov:90151@1- SHA-256
ea416d2f08c6f74809b1ee9b367930027442f1ef63e5b17313d1f2fe9ae00030
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. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.
(b) Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.