21 CFR 886.1385 - Polymethylmethacrylate (PMMA) diagnostic contact lens.

Regulations last checked for updates: May 07, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart B [§ 886.1040 - § 886.1945]

§ 886.1385 - Polymethylmethacrylate (PMMA) diagnostic contact lens.

(a) Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

cite as: 21 CFR 886.1385