[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1002.13]

[Page 603]
 
                        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 B_Required Manufacturers' Reports for Listed Electronic Products
 
Sec. 1002.13  Annual reports.

    (a) Every manufacturer of products requiring an annual report as 
specified in table 1 of Sec. 1002.1 shall submit an annual report 
summarizing the contents of the records required to be maintained by 
Sec. 1002.30(a) and providing the volume of products produced, sold, or 
installed.
    (b) Reports are due annually by September 1. Such reports shall 
cover the 12-month period ending on June 30 preceding the due date of 
the report.
    (c) New models of a model family that do not involve changes in 
radiation emission or requirements of a performance standard do not 
require supplemental reports prior to introduction into commerce. These 
model numbers should be reported in quarterly updates to the annual 
report.