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Electronic Submission Requirements for Medical Device Submissions

This guidance outlines FDA's implementation of electronic submission requirements for medical device submissions under Section 745A(b) of the FD&C Act. It specifies which submissions must be submitted electronically, the implementation process, and criteria for waivers and exemptions.

  1. Review the list of submission types requiring electronic format to identify which apply to your organization
  2. Monitor FDA website for individual guidance documents specifying electronic formats for specific submission types
  3. Plan for transition to electronic submissions according to the timetables that will be specified in individual guidances
  4. Establish internal processes to ensure compliance with electronic submission requirements
  5. For exempt submissions, consider voluntary electronic submission to facilitate review process
  6. Monitor Federal Register notices for updates on new or revised electronic submission requirements
  7. Ensure capability to submit in required electronic format before mandatory implementation dates
  8. Consider requesting waivers if needed, based on criteria that will be specified in individual guidances

Key Considerations

Other considerations

No specific norms or standards referenced in this guidance.


Original guidance

  • Electronic Submission Requirements for Medical Device Submissions
  • HTML / PDF
  • Issue date: 2020-07-15
  • Last changed date: 2020-07-14
  • Status: FINAL
  • Official FDA topics: Medical Devices, Electronic Submissions, Biologics
  • ReguVirta summary file ID: a754cd501762a234225654be53a00dbc
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