21 CFR 886.5540
§ 886.5540 Low-vision magnifier.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.5540, § 886.5540 Low-vision magnifier, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91015
- Permanent ID
ys:prov:91015@1- SHA-256
b2386389255fa369a9d058ae4c059e585a3b255394770649d8747b25137c4e71
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Full text
(a) Identification. A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.
(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. 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.