[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1003.11]

[Page 578]
 
                        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 B--Discovery of Defect or Failure to Comply
 
Sec. 1003.11  Determination by Secretary that product fails to comply or has a defect.

    (a) If, the Secretary, through testing, inspection, research, or 
examination of reports or other data, determines that any electronic 
product does not comply with an applicable Federal standard issued 
pursuant to the Act or has a defect, he shall immediately notify the 
manufacturer of the product in writing specifying:
    (1) The defect in the product or the manner in which the product 
fails to comply with the applicable Federal standard;
    (2) The Secretary's findings, with references to the tests, 
inspections, studies, or reports upon which such findings are based;
    (3) A reasonable period of time during which the manufacturer may 
present his views and evidence to establish that there is no failure of 
compliance or that the alleged defect does not exist or does not relate 
to safety of use of the product by reason of the emission of electronic 
product radiation.

The manufacturer shall have an opportunity for a regulatory hearing 
before the Food and Drug Administration pursuant to part 16 of this 
chapter.
    (b) Every manufacturer who receives a notice under paragraph (a) of 
this section shall immediately advise the Secretary in writing of the 
total number of such product units produced and the approximate number 
of such product units which have left the place of manufacture.
    (c) If, after the expiration of the period of time specified in the 
notice, the Secretary determines that the product has a defect or does 
not comply with an applicable Federal standard and the manufacturer has 
not applied for an exemption, he shall direct the manufacturer to 
furnish the notification to the persons specified in Sec. 1003.10(b) in 
the manner specified in Sec. 1003.21. The manufacturer shall within 14 
days from the date of receipt of such directive furnish the required 
notification.

[38 FR 28628, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42 
FR 15676, Mar. 22, 1977]