[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1010.2]

[Page 595]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 1010.2  Certification.

    (a) Every manufacturer of an electronic product for which an 
applicable standard is in effect under this subchapter shall furnish to 
the dealer or distributor, at the time of delivery of such product, the 
certification that such product conforms to all applicable standards 
under this subchapter.
    (b) The certification shall be in the form of a label or tag 
permanently affixed to or inscribed on such product so as to be legible 
and readily accessible to view when the product is fully assembled for 
use, unless the applicable standard prescribes some other manner of 
certification. All such labels or tags shall be in the English language.
    (c) Such certification shall be based upon a test, in accordance 
with the standard, of the individual article to which it is attached or 
upon a testing program which is in accordance with good manufacturing 
practices. The Director, Center for Devices and Radiological Health may 
disapprove such a testing program on the grounds that it does not assure 
the adequacy of safeguards against hazardous electronic product 
radiation or that it does not assure that electronic products comply 
with the standards prescribed under this subchapter.
    (d) In the case of products for which it is not feasible to certify 
in accordance with paragraph (b) of this section, upon application by 
the manufacturer, the Director, Center for Devices and Radiological 
Health may approve an alternate means by which such certification may be 
provided.

[38 FR 28631, Oct. 15, 1973, as amended at 40 FR 32257, July 31, 1975; 
42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988]