TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 886 - OPHTHALMIC DEVICES

subpart b - DIAGNOSTIC DEVICES

886.1700 - Pupillometer.

  (a) Identification. A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.

  (b) Classification. Class I (general controls). The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The manual device is also exempt from the current good manufacturing practice regulations 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 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001]