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e-CFR data is current as of July 31, 2020

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1605


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


§886.1605   Perimeter.

(a) Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

(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.

[55 FR 48442, Nov. 20, 1990, as amended at 66 FR 38811, July 25, 2001]

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