GroundRules
21 CFR 886.4280: Intraocular pressure measuring device.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 886—OPHTHALMIC DEVICES
- Subpart E—Surgical Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON