Performance Standards: Radiological Health Program

• Performance Standards for Electronic Products: General (21 CFR 1010)
• Specific Performance Standards for Electronic Products (21 CFR 1020 - 1050)
  • Television receivers with cathode ray tubes (21 CFR 1020.10)
  • Cold-cathode gas discharge tubes (21 CFR 1020.20)
  • Diagnostic x-ray systems and their major components (21 CFR 1020.30)
    • Radiographic equipment (21 CFR 1020.31)
    • Fluoroscopic equipment (21 CFR 1020.32)
    • Computed tomography (CT) equipment (21 CFR 1020.33)
  • Cabinet x-ray systems (21 CFR 1020.40)
  • Microwave ovens (21 CFR 1030.10)
  • Laser products (21 CFR 1040.10)
    • Specific purpose laser products (21 CFR 1040.11)
  • Sunlamp products and ultraviolet lamps intended for use in sunlamp products (21 CFR 1040.20)
  • High-intensity mercury vapor discharge lamps (21 CFR 1040.30)

Medical Devices

Electronic Products that are also Medical Devices are subject to the device provisions of the Federal Food, Drug, and Cosmetic Act. For more information, see How to Study and Market Your Device.