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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 886: OPHTHALMIC DEVICES
Subpart B: Diagnostic Devices
886.1905 - Nystagmus tape.
(a) Identification. Nystagmus tape is a device that is a long, narrow strip of fabric or other flexible material on which a series of objects are printed. The device is intended to be moved across a patient's field of vision to elicit optokinetic nystagmus (abnormal and irregular eye movements) and to test for blindness.
(b) Classification. Class I (general controls). 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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of ? 820.180, with respect to general requirements concerning records, and ? 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001]
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