[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1003.2]

[Page 563]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 1003--NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 1003.2  Defect in an electronic product.

    For the purpose of this part, an electronic product shall be 
considered to have a defect which relates to the safety of use by reason 
of the emission of electronic product radiation if:
    (a) It is a product which does not utilize the emission of 
electronic product radiation in order to accomplish its purpose, and 
from which such emissions are unintended, and as a result of its design, 
production or assembly;
    (1) It emits electronic product radiation which creates a risk of 
injury, including genetic injury, to any person, or
    (2) It fails to conform to its design specifications relating to 
electronic radiation emissions; or
    (b) It is a product which utilizes electronic product radiation to 
accomplish its primary purpose and from which such emissions are 
intended, and as a result of its design, production or assembly it;
    (1) Fails to conform to its design specifications relating to the 
emission of electronic product radiation; or
    (2) Without regard to the design specifications of the product, 
emits electronic product radiation unnecessary to the accomplishment of 
its primary purpose which creates a risk of injury, including genetic 
injury to any person; or
    (3) Fails to accomplish the intended purpose.