Overview of Regulations for
Electronic Product Radiation Control

 

Aspects of Radiation Control Included in Performance Standards

Radiation Controls

Testing

Labeling

 

Summary of Specific Performance Standards

Television Receivers, 21 CFR 1020.10

 

 

Microwave Ovens, 21 CFR 1030.10

Lasers and Laser Systems, 21 CFR 1040.10

Specific Laser Products, 21 CFR 1040.11

 

Summary of Reporting Requirements

Variances; Exemptions, 21 CFR 1010.4, 1010.5

Accidental Radiation Occurrences, 21 CFR 1002.20

 

Product Reports (also Supplements, Abbreviated), 21 CFR 1002.10 1002.12

Annual Reports, 21 CFR 1002.13

Notice of Defect or Noncompliance, 21 CFR 1003.20

 

Summary of Other Radiation Control Regulations

Certification and Identification Labels, 21 CFR 1010.2 1010.3

Defect in an Electronic Product, 21 CFR 1003.2

 

Determination of Noncompliance or Defect, 21 CFR 1003.10 1003.11

Exemption from Notification, 21 CFR 1003.30 1003.31

Repurchase, Repair, and Replacement, 21 CFR 1004.1 1004.3

Importation Requirements, 21 CFR 1005.3 1005.10

Bringing Imported Products into Compliance, 21 CFR 1005.21 1005.25

 

Summary of Compliance Actions for Radiation Control Act Violations

FDA Administrative Actions, 21 CFR 1004.6, 1010.2(c), 1005.3

Actions through U.S. District Courts