[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: 21CFR1002.20]

[Page 574]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1002--RECORDS AND REPORTS--Table of Contents
 
  Subpart C--Manufacturers' Reports on Accidental Radiation Occurrences
 
Sec. 1002.20  Reporting of accidental radiation occurrences.


    (a) Manufacturers of electronic products shall, where reasonable 
grounds for suspecting that such an incident has occurred, immediately 
report to the Director, Center for Devices and Radiological Health, all 
accidental radiation occurrences reported to or otherwise known to the 
manufacturer and arising from the manufacturing, testing, or use of any 
product introduced or intended to be introduced into commerce by such 
manufacturer. Reasonable grounds include, but are not necessarily 
limited to, professional, scientific, or medical facts or opinions 
documented or otherwise, that conclude or lead to the conclusion that 
such an incident has occurred.
    (b) Such reports shall be addressed to the Director, Center for 
Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857, 
and the reports and their envelopes shall be distinctly marked ``Report 
on Sec. 1002.20'' and shall contain all of the following information 
where known to the manufacturer:
    (1) The nature of the accidental radiation occurrence;
    (2) The location at which the accidental radiation occurrence 
occurred;
    (3) The manufacturer, type, and model number of the electronic 
product or products involved;
    (4) The circumstances surrounding the accidental radiation 
occurrence, including causes;
    (5) The number of persons involved, adversely affected, or exposed 
during the accidental radiation occurrence, the nature and magnitude of 
their exposure and/or injuries and, if requested by the Director, Center 
for Devices and Radiological Health, the names of the persons involved;
    (6) The actions, if any, which may have been taken by the 
manufacturer, to control, correct, or eliminate the causes and to 
prevent reoccurrence; and
    (7) Any other pertinent information with respect to the accidental 
radiation occurrence.
    (c) If a manufacturer is required to report to the Director under 
paragraph (a) of this section and also is required to report under part 
803 of this chapter, the manufacturer shall report in accordance with 
part 803. If a manufacturer is required to report to the Director under 
paragraph (a) of this section and is not required to report under part 
803, the manufacturer shall report in accordance with paragraph (a) of 
this section. A manufacturer need not file a separate report under this 
section if an incident involving an accidental radiation occurrence is 
associated with a defect or noncompliance and is reported pursuant to 
Sec. 1003.10 of this chapter.

[38 FR 28625, Oct. 15, 1973, as amended at 49 FR 36351, Sept. 14, 1984; 
53 FR 11254, Apr. 6, 1988; 60 FR 48386, Sept. 19, 1995]