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21 CFR 886.5842

§ 886.5842 Spectacle frame.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 886.5842, § 886.5842 Spectacle frame, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91023
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(a) Identification. A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors. (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 § 886.9.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.