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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR1002.13]
See Related Information on Annual reports. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER J--RADIOLOGICAL HEALTH

PART 1002 -- RECORDS AND REPORTS

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 1002.1 shall submit an annual report summarizing the contents of the records required to be maintained by 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.

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