[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: 21CFR886.1665]

[Page 440]
 
                        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. 886.1665  Ophthalmic rotary prism.

    (a) Identification. An ophthalmic rotary prism is a device with 
various prismatic powers intended to be handheld and used to measure 
ocular deviation in patients with latent or manifest strabismus (eye 
muscle deviation).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is 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 35605, Sept. 14, 1988]