CDRH eSubmitter Program

The 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 Tool

For premarket submissions, see:

• Send and Track Medical Device Premarket Submissions Online: CDRH Portal