21 C.F.R. § 886.1800

Current through November 30, 2024
Section 886.1800 - Schirmer strip
(a)Identification. A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to stimulate and evaluate formation of tears.
(b)Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, 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 .

21 C.F.R. §886.1800

52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812 , July 25, 2001