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Radiological Health Program

Filing Radiation Safety (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, enhancements are incorporated monthly and your feedback is encouraged. Use of the eSubmitter software is desired, however, if you must submit in paper form, soft copies are available in Adobe Portable Document Format (PDF) and/or Microsoft Word documents from the Radiological Health homepage at www.fda.gov/cdrh/radhealth.

The CeSub eSubmitter software allows electronic filing of the following:

1) 2579 for Report of Assembly of a Diagnostic X-Ray System for Assemblers

2) Radiological Health Reports for Manufacturers, Importers, and Consultants

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

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 above. 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 for an initial test account. Upon successful transmission of the test submission, your account will be promoted to a production account. RadHealth Submissions utilizing the eSubmitter Software may also be burned to CD and mailed to CDRH. Please download the software for more information.

If you have any questions regarding the registration process or the Gateway in general, please contact the help desk as indicated on the Contact Us page.

Updated September 9, 2008

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