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Summary Of The Electronic Product Radiation Control Provisions Of The Federal Food, Drug, And Cosmetic Act

Radiological Health Home

The Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) are located in Sections 531 through 542 of the Act. They apply to any "electronic product" which is defined as:

"Electronic product radiation" is defined as:

Examples of electronic products:

SUMMARY OF PERFORMANCE STANDARDS
(Consult Regulations for full text)

21 CFR 1020.10. Television Receivers

21 CFR 1020.20. Cold-cathode Discharge Tubes

21 CFR 1020.30. Diagnostic X-Ray Systems and their Major Components

21 CFR 1020.31. Radiographic Equipment

21 CFR 1020.32. Fluoroscopic Equipment

21 CFR 1020.33. Computed Tomography (CT) Equipment

21 CFR 1020.40. Cabinet X-Ray Systems

21 CFR 1030.10. Microwave Ovens

21 CFR 1040.10. Lasers and Laser Systems

21 CFR 1040.11. Specific Laser Products

21 CFR 1040.20. Sunlamps and Sunlamp Products

21 CFR 1040.30. High-intensity Mercury Vapor Discharge Lamps

21 CFR 1050.10. Ultrasonic Therapy Products

SUMMARY OF REPORTING REQUIREMENTS
(Consult Regulations for full text)

21 CFR 1010.4, 1010.5. Variances; Exemptions

21 CFR 1002.20. Accidental Radiation Occurrences

21 CFR 1002.10, 11, 12. Product Reports (also Supplements, Abbreviated)

21 CFR 1002.13. Annual Reports

21 CFR 1003.20. Notice of Defect or Noncompliance

SUMMARY OF OTHER RADIATION CONTROL REGULATIONS
(Consult Regulations for full text)

21 CFR 1003.2. Defect in an Electronic Product

21 CFR 1003.10/.11. Determination of Noncompliance or Defect

21 CFR 1003.30/.31. Exemption from Notification

21 CFR 1004.1/.2/.3. Repurchase, Repair, and Replacement

21 CFR 1005.3/.10. Importation Requirements

21 CFR 1005.21 / .22 / .23 / .24 / .25. Bringing Imported Products into Compliance

21 CFR 1010.2/.3. Certification and Identification Labels

SUMMARY OF COMPLIANCE ACTIONS FOR RADIATION CONTROL ACT VIOLATIONS
(Consult Act AND REGULATIONS for full text)

A. FDA Administrative Actions

B. Actions through U.S. District Courts

 

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