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                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
          CDRH eSubmitter ProgramFDA eSubmitter CDRH eSubmitter Program
  
  	
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    PrintThe Center for Devices and Radiological Health offers the following eSubmitter programs. The FDA eSubmitter software provides numerous reporting guides and forms. The electronic templates currently available in eSubmitter represent most forms that industry is required to submit to the FDA. For details about specific program areas, see below:

CDRH

Radiological Health Program

	Note: Filing Radiation Safety Reports for many radiation emitting products is required by law. The CDRH eSubmitter suite of templates provides replicas and streamlined versions of most of the paper report forms and various correspondence types available on the FDA Forms website.
	Diagnostic X-ray Reports of Assembly
	Assemblers of diagnostic x-ray systems have certain responsibilities based on component compatibility and following manufacturer installation instructions. More information can be found on this web page.
	Electronic Medical Device Reporting (eMDR)
	eSubmitter-eCopies ToolFor premarket submissions, see:

Send and Track Medical Device Premarket Submissions Online: CDRH Portal

                                                                                  Content current as of:
      10/03/2022
              
              
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
 
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