[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR886.1190]

[Page 471-472]
 
                        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. 886.1190  Distometer.

    (a) Identification. A distometer is a device intended to measure the 
distance between the cornea and a corrective lens during refraction to 
help measure the change of the visual image when a lens is in place.
    (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 472]]

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]