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Title 21 Part 886 → Subpart B → §886.1800

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1800

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1800

e-CFR data is current as of September 18, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1800


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices


§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.

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