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U.S. Department of Health and Human Services

For Industry

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Radiological Health Program

Filing Radiation Safety (Product) Reports for radiation emitting products is required by law. The FDA eSubmitter software replicates several reporting guides and forms, which have been available in hard copy for decades. The electronic templates currently available in eSubmitter represent most forms industry is required to submit to FDA.
The FDA eSubmitter software allows electronic filing of the following:

1) Form FDA 2579, Report of Assembly of a Diagnostic X-Ray System

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

Once you’ve prepared your report using FDA eSubmitter, you can submit your document using FDA’s Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions. The ESG authenticates and validates electronic submissions and routes it to CDRH. You will receive acknowledgement of receipt for your submission within minutes. To use the ESG, you must perform a number of preparatory steps to set up an account. Information on how to establish an account, the steps that have to be taken, and tutorials on various aspects of setting up and using the gateway may be found on the Electronic Submissions Gateway website. Please visit this website for instructions and to register as a trading partner for an initial test account. Upon completion of required activities and successful transmission of the test submission, your account will be promoted to a production account.

Alternatively, FDA eSubmitter can load your electronic submissions onto a CD and mailed to CDRH for processing. Once we process your electronic submission, CDRH will send an electronic acknowledgement letter to you via email, usually within a few days.

Although use of the FDA eSubmitter software is desired, if you must submit in paper form, soft copies are available in Adobe Portable Document Format (PDF) and/or Microsoft Word documents from the Radiation-Emitting Products homepage.

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.

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