FDA e-submissions for medical devices

A new guidance finalised by the US Food and Drug Administration (FDA) outlines the framework for electronic submissions for medical devices.

The guidance clarifies submissions which can be made electronically:

  • Premarket notifications (501k)
  • De novo submissions
  • Premarket approval applications (PMAs)
  • Product development protocols
  • Investigational device exemption applications
  • Humanitarian device exemptions
  • Emergency Use Authorisations
  • Specified Investigational new drug applications (IND)
  • Biological license applications (BLA)

Subsequent submissions to an original submission must also be done electronically.

Exemptions to e-submission regulations include expanded access compassionate use requests, emergency use reports and adverse event reports. However, e-submission is still encouraged.

Upcoming individual guidances will specify the timelines and details for each submission type.

To view the full guidance on electronic submissions, click here.