[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: 21CFR895.1]

[Page 546-547]
 
                        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. 895.1  Scope.


    (a) This part describes the procedures by which the Commissioner may 
institute proceedings to make a device intended for human use that 
presents

[[Page 547]]

substantial deception or an unreasonable and substantial risk of illness 
or injury a banned device.
    (b) This part applies to any ``device'', as defined in section 
201(h) of the Federal Food, Drug, and Cosmetic Act (act) that is 
intended for human use.
    (c) A device that is made a banned device in accordance with this 
part is adulterated under section 501(g) of the act. A restricted device 
that is banned may also be misbranded under section 502(q) of the act.
    (d) Although this part does not cover devices intended for animal 
use, the manufacturer, distributor, importer, or any other person(s) 
responsible for the labeling of the device that is banned cannot avoid 
the ban by relabeling the device for veterinary use. A device that has 
been banned from human use but that also has a valid veterinary use may 
be marketed for use as a veterinary device only under the following 
conditions: The device shall comply with all requirements applicable to 
veterinary devices under the Federal Food, Drug, and Cosmetic Act and 
this chapter, and the label for the device shall bear the following 
statement: ``For Veterinary Use Only. Caution: Federal law prohibits the 
distribution of this device for human use.'' A device so labeled, 
however, that is determined by the Food and Drug Administration to be 
intended for human use, will be considered to be a banned device. In 
determining whether such a device is intended for human use, the Food 
and Drug Administration will consider, among other things, the ultimate 
destination of the device.