[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.5]

[Page 101]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 812_INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 812.5  Labeling of investigational devices.

    (a) Contents. An investigational device or its immediate package 
shall bear a label with the following information: the name and place of 
business of the manufacturer, packer, or distributor (in accordance with 
Sec. 801.1), the quantity of contents, if appropriate, and the 
following statement: ``CAUTION--Investigational device. Limited by 
Federal (or United States) law to investigational use.'' The label or 
other labeling shall describe all relevant contraindications, hazards, 
adverse effects, interfering substances or devices, warnings, and 
precautions.
    (b) Prohibitions. The labeling of an investigational device shall 
not bear any statement that is false or misleading in any particular and 
shall not represent that the device is safe or effective for the 
purposes for which it is being investigated.
    (c) Animal research. An investigational device shipped solely for 
research on or with laboratory animals shall bear on its label the 
following statement: ``CAUTION--Device for investigational use in 
laboratory animals or other tests that do not involve human subjects.''

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980]