FDA > CDRH > CeSub eSubmitter > Radiological Health Program

Radiological Health Program

Filing product reports for radiation emitting products is required by law. The CeSub eSubmitter software replicates several of these reporting guides, which have been available in hard copy for decades. The electronic reporting guides available in eSubmitter are still under development, and the software is regarded as a pilot program. If using the eSubmitter software is not desirable, you may continue to complete hard copies of the report, which are available as Adobe Portable Document Format (PDF) and/or Microsoft Word documents from the Radiological Health homepage at www.fda.gov/cdrh/radhealth.

Rad Health utilizes the FDA Gateway, an agency-wide entry point for all electronic submissions, to receive electronic Radiation Safety Product, Annual, Abbreviated and Supplemental Reports and correspondence listed below. The Gateway authenticates and validates electronic submissions and routes it to CDRH. Please visit http://www.fda.gov/esg/ to register as a trading partner. If you have any questions regarding the registration process or the Gateway in general, please contact the help desk as indicated on the website.

The CeSub eSubmitter software includes the following Radiological Health Reports for Manufacturers, Importers, and Consultants:

• Laser Products:
• Laser Product Report
• Laser Light Show Product Report
• Laser Light Show Variance Application Form #3147
• Laser Light Show Notification
• Laser Annual Report
• Laser OEM Registration Report
• Diagnostic X-Ray Products:
• Diagnostic X-Ray CT Product Report
• Diagnostic X-Ray Annual Report
• Diagnostic X-Ray Systems and Their Major Components Product Report
• Cabinet X-Ray Products:
• Cabinet X-Ray Product Report (Industrial, Analytical)
• Cabinet X-Ray Annual Report
• Cabinet X-Ray Field Test
• Medical, Analytical, and Industrial X-Ray (Other than Diagnostic or Cabinet X-Ray):
  • Medical, Analytical, and Industrial X-Ray (Other than Diagnostic or Cabinet X-Ray) Annual Report
• Mercury Vapor Lamp Products:
  • High Intensity Mercury Vapor Discharge and Metal Halide Lamp Product Report
  • High Intensity Mercury Vapor Discharge and Metal Halide Lamp Products Annual Report
• Microwave Oven Products:
  • Microwave Oven Products Annual Report
• Sunlamp Products:
  • Sunlamp Product Report
  • Sunlamp Products Annual Report
• Television Receivers, Television Projectors, Video Computer Monitors Containing Cathode Ray Tubes (CRT):
  • Television Receivers, Television Projectors, Video Computer Monitors Containing Cathode Ray Tubes (CRT) Annual Report
• Therapy Ultrasound Products:
• Therapy Ultrasound Product Report
• Therapy Ultrasound Annual Report
• Other:
• Abbreviated Report
• General Variance Application Form
• Accidental Radiation Occurrence Report

Updated January 24, 2008