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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER J - RADIOLOGICAL HEALTH
 
PART 1002RECORDS AND REPORTS
 

Subpart A - General Provisions
   § 1002.1 - Applicability.
   § 1002.2 - [Reserved]
   § 1002.3 - Notification to user of performance and technical data.
   § 1002.4 - Confidentiality of information.
   § 1002.7 - Submission of data and reports.

Subpart B - Required Manufacturers' Reports for Listed Electronic Products
   § 1002.10 - Product reports.
   § 1002.11 - Supplemental reports.
   § 1002.12 - Abbreviated reports.
   § 1002.13 - Annual reports.

Subpart C - Manufacturers' Reports on Accidental Radiation Occurrences
   § 1002.20 - Reporting of accidental radiation occurrences.

Subpart D - Manufacturers' Records
   § 1002.30 - Records to be maintained by manufacturers.
   § 1002.31 - Preservation and inspection of records.

Subpart E - Dealer and Distributor Records
   § 1002.40 - Records to be obtained by dealers and distributors.
   § 1002.41 - Disposition of records obtained by dealers and distributors.
   § 1002.42 - Confidentiality of records furnished by dealers and distributors.

Subpart F - Exemptions From Records and Reports Requirements
   § 1002.50 - Special exemptions.
   § 1002.51 - Exemptions for manufacturers of products intended for the U.S. Government.

Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 374.
Source: 38 FR 28625, Oct. 15, 1973, unless otherwise noted.

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