Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart B - Diagnostic Devices / § 886.1800 Schirmer strip.
§ 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.