[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: 21CFR895.25]

[Page 550]
 
                        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. 895.25  Labeling.

    (a) If the Commissioner determines that the substantial deception or 
unreasonable and substantial risk of illness or injury or the 
unreasonable, direct, and substantial danger to the health of 
individuals presented by a device can be corrected or eliminated by 
labeling or a change in labeling, or change in advertising if the device 
is a restricted device, the Commissioner will provide written notice to 
the manufacturer, distributor, importer, or any other person(s) 
responsible for the labeling or advertising of the device specifying:
    (1) The deception or risk of illness or injury or the danger to the 
health of individuals,
    (2) The labeling or change in labeling, or change in advertising if 
the device is a restricted device, necessary to correct the deception or 
eliminate or reduce such risk or danger, and
    (3) The period of time within which the labeling, change in 
labeling, or change in advertising must be accomplished.
    (b) In specifying the labeling or change in labeling or change in 
advertising to correct the deception or to eliminate or reduce the risk 
of illness or injury or the danger to the health of individuals, the 
Commissioner may require the manufacturer, distributor, importer, or any 
other person(s) responsible for the labeling or advertising of the 
device to include in labeling for the device, and in advertising if the 
device is a restricted device, a statement, notice, or warning. Such 
statement, notice, or warning shall be in the manner and form prescribed 
by the Commissioner and shall identify the deception or risk of illness 
or injury or the unreasonable, direct, and substantial danger to the 
health of individuals associated with the device as previously labeled. 
Such statement, notice, or warning shall be used in the labeling and 
advertising of the device for a time period specified by the 
Commissioner on the basis of the degree of deception, risk of illness or 
injury, or danger to health; the frequency of sale of the device; the 
length of time the device has been on the market; the intended uses of 
the device; the method of its use; and any other factors that the 
Commissioner considers pertinent.
    (c) The Commissioner will allow a manufacturer, distributor, 
importer, or any other person(s) responsible for the labeling or 
advertising of the device a reasonable time, considering the deception 
or risk of illness or injury or the danger to the health of individuals 
presented by the device, within which to accomplish the required 
labeling, change in labeling, and, if the device is a restricted device, 
any change in advertising. The Commissioner may, however, request that 
no additional devices be introduced into commerce until the labeling or 
change in labeling, or change in advertising is accomplished by the 
manufacturer, distributor, importer, or other person(s) responsible for 
the labeling or advertising of the device.
    (d) If such voluntary action is not taken, the Commissioner may take 
action under other sections of the act to prevent the introduction of 
the devices into commerce. The Commissioner may consider the failure of 
a manufacturer, distributor, importer, or any other person(s) 
responsible for the labeling or advertising of the device to accomplish 
the required labeling or change in labeling, or change in advertising in 
accordance with this section as a basis for initiating a proceeding to 
make a device a banned device in accordance with Sec. 895.21(d) and 
when appropriate to establish a special effective date in accordance 
with Sec. 895.30.