[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR886.1170]

[Page 451-452]
 
                        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. 886.1170  Color vision tester.

    (a) Identification. A color vision tester is a device that consists 
of various colored materials, such as colored yarns or color vision 
plates (multicolored plates which patients with color vision deficiency 
would perceive as being of one color), intended to evaluate color 
vision.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter,

[[Page 452]]

subject to the limitations in Sec. 886.9. The device 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 
complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 
66 FR 38810, July 25, 2001]