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Title 21 Part 886 → Subpart B → §886.1200

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1200

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1200

e-CFR data is current as of September 19, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1200


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


§886.1200   Optokinetic drum.

(a) Identification. An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.

(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 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001]