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 the 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
• 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

How to submit required reports

All Radiation Safety reports may now be submitted by email to CDRH at [email protected]. This includes all report types, such as product reports, annual reports, and supplemental reports of all types, and all communications such as notifications of defect/failure to comply, corrective action plan (CAP) proposals, and accidental radiation occurrences (AROs). Reports should be submitted in PDF format, or packaged by the eSubmitter packaging procedures, and attached to your email. eSubmissions no longer need to be transferred to a physical medium and mailed to the CDRH Document Control Center. An eSubmitter user does not need to acquire an FDA Electronic Submissions Gateway account.

Note: Device premarket submissions (such as PMAs, 510(k)s, etc.) or electronic medical device reporting (eMDR) submissions are NOT accepted by this email address. Reports concerning a radiation-emitting product or device can still be submitted by the three ways listed below:

• Electronic by Email
  • eSubmitter Software
  • PDF Forms
• Electronic through the FDA Gateway (eSubmitter)
• By Mail

Electronic by Email

eSubmitter software

Preparing your submissions using the FDA eSubmitter electronic submissions software is the best way to prepare information for submission to the FDA.

• Download the software and its user manual
• Tutorials to get you started

Once the submission has been completed and packaged following the FDA eSubmitter instructions, you may email the report package (a ZIP file) and your signed submittal letter to the FDA email. If the submission is a report, the files will be processed by our Document Control Center and you will receive an acknowledgement email within a few days giving you the FDA assigned Accession Number for the report.

This option may be the best option when you have a need to submit a report immediately, but it doesn’t offer the fastest response for the acknowledgement email notice. The FDA Gateway provides the fastest response (minutes instead of days).

Email your eSubmitter prepared report to [email protected]. PDF by Email

Product reports may also be prepared using the fillable PDF reporting guide and emailed to [email protected]. These reports will be controlled by the Document Control Center and an acknowledgement letter will be emailed to the reporting official and the submitter within about 30 days.

The paper reporting guides are available and can be accessed on the individual electronic product-specific webpage found on the A-Z list of Regulated Products & Procedures.

Electronic through the FDA Gateway (eSubmitter)

Preparing the report for submission via the FDA Electronic Submissions Gateway is the same as preparing one to submit by email. However, it is necessary to establish a WebTrader account with the FDA Gateway before you can submit through the Gateway.

The FDA Electronic Submissions Gateway has its own separate web site where you can find information about the Gateway and the procedures for setting up an account. Of particular help are the links on the left side of the homepage to Center-Specific Submission Preparation Guidelines, Setting up a WebTrader Account Checklist, and the Tutorials link under Resources for You.

Submissions made through the FDA Gateway are automatically routed to the proper Center for control by its Document Control Center. Reports submitted to FDA for radiation-emitting products will typically be acknowledged by email within a few minutes or hours.

By Mail

Alternatively, electronic product radiation control reports may be prepared using the fillable PDF reporting guides and mailed to the following address:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

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.