[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: 21CFR882.1790]

[Page 435]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 882_NEUROLOGICAL DEVICES--Table of Contents
 
                Subpart B_Neurological Diagnostic Devices
 
Sec. 882.1790  Ocular plethysmograph.

    (a) Identification. An ocular plethysmograph is a device used to 
measure or detect volume changes in the eye produced by pulsations of 
the artery, to diagnose carotid artery occlusive disease (restrictions 
on blood flow in the carotid artery).
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before September 21, 2004, for any ocular 
plethysmograph that was in commercial distribution before May 28, 1976. 
Any other ocular plethysmograph shall have an approved PMA or declared 
completed PDP in effect before being placed in commercial distribution.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 
1987; 69 FR 34920, June 23, 2004]