Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                FDA eSubmitter

FDA eSubmitter

                        CBER eSubmitter Program
          CDRH eSubmitter Program
          Using eSubmitter to Prepare Tobacco Product Submissions
          eSubmitter Download and Installation
          eSubmitter Tutorial Videos
          Contact eSubmitter
          CVM eSubmitter Programs
          eSubmitter Application History Home
          For Industry
          FDA eSubmitter
          Radiological Health ProgramFDA eSubmitter Radiological Health Program
  
  	
    Share
    Post
    Linkedin

    Email
    PrintRadiation Safety reports in PDF format or packaged using eSubmitter procedures may now be submitted as attachments and sent by email to the FDA’s Center for Devices and Radiological Health at RadHealthCustomerService@fda.hhs.gov. For additional information, please visit Submitting Reports and Requirements for Maintaining Records for Radiation.

Information accepted by this email address includes product reports, annual reports, and supplemental reports. This also includes communications such as notifications of defect or failure to comply, corrective action plan (CAP) proposals, and accidental radiation occurrences (AROs).

Note: Device premarket submissions (such as PMAs and 510(k)s) or electronic medical device reporting (eMDR) submissions are NOT accepted by this email address.


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 ReportHow to submit required reports

All Radiation Safety reports may now be submitted by email to CDRH at RadHealthCustomerService@fda.hhs.gov. 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 MailElectronic 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 startedOnce 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 RadHealthCustomerService@fda.hhs.gov. PDF by Email

Product reports may also be prepared using the fillable PDF reporting guide and emailed to RadHealthCustomerService@fda.hhs.gov. 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.

                                                                                  Content current as of:
      12/09/2021
              
              
Regulated Product(s)
		 Radiation-Emitting ProductsFDA eSubmitter

          
                        CBER eSubmitter Program
          CDRH eSubmitter Program
          Using eSubmitter to Prepare Tobacco Product Submissions
          eSubmitter Download and Installation
          eSubmitter Tutorial Videos
          Contact eSubmitter
          CVM eSubmitter Programs
          eSubmitter Application History
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop