[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR812.5]



[Page 101-102]

 

                        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



[[Page 102]]



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]