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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 1003NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
 

Subpart A - General Provisions
   § 1003.1 - Applicability.
   § 1003.2 - Defect in an electronic product.
   § 1003.5 - Effect of regulations on other laws.

Subpart B - Discovery of Defect or Failure To Comply
   § 1003.10 - Discovery of defect or failure of compliance by manufacturer; notice requirements.
   § 1003.11 - Determination by Secretary that product fails to comply or has a defect.

Subpart C - Notification
   § 1003.20 - Notification by the manufacturer to the Secretary.
   § 1003.21 - Notification by the manufacturer to affected persons.
   § 1003.22 - Copies of communications sent to purchasers, dealers or distributors.

Subpart D - Exemptions From Notification Requirements
   § 1003.30 - Application for exemption from notification requirements.
   § 1003.31 - Granting the exemption.

Authority: 21 U.S.C. 360hh-360ss.
Source: 38 FR 28628, Oct. 15, 1973, unless otherwise noted.

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