[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR886.1605]

[Page 439]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 886--OPHTHALMIC DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 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. The manual device is exempt from the 
premarket notification procedures in part 807, subpart E of this 
chapter, and it is also exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198 with respect to the complaint files.

[55 FR 48442, Nov. 20, 1990]