21 CFR 874.4770
§ 874.4770 Otoscope.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 874.4770, § 874.4770 Otoscope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90249
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Full text
(a) Identification. An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.
(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 § 874.9 only when used in the external ear canal.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.