[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: 21CFR895.20]

[Page 547]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 895_BANNED DEVICES--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 895.20  General.

    The Commissioner may initiate a proceeding to make a device a banned 
device whenever the Commissioner finds, on the basis of all available 
data and information, that the device presents substantial deception or 
an unreasonable and substantial risk of illness or injury that the 
Commissioner determines cannot be, or has not been, corrected or 
eliminated by labeling or by a change in labeling, or by a change in 
advertising if the device is a restricted device.

[44 FR 29221, May 18, 1979, as amended at 57 FR 58405, Dec. 10, 1992]