21 CFR 886.4280
§ 886.4280 Intraocular pressure measuring device.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.4280, § 886.4280 Intraocular pressure measuring device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90983
- Permanent ID
ys:prov:90983@1- SHA-256
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Full text
(a) Identification. An intraocular pressure measuring device is a manual or AC-powered device intended to measure intraocular pressure. Also included are any devices found by FDA to be substantially equivalent to such devices. Accessories for the device may include calibrators or recorders. The device is intended for use in the diagnosis of glaucoma.
(b) Classification. Class III.
(c) Date PMA or notice of completion of PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.