FDA electronic format submission for medical device

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)
• Evaluation of automatic class III designation request (De Novos) submissions (513(f)(2))
• Premarket approval applications (PMAs) including transitional PMAs and modular 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.

Individual guidance documents will be developed by FDA to specify the electronic
format for each submission type. The required format(s) for the specific submissions and corresponding timetable(s) for implementation will be specified in these individual guidances.

Link for guidance document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab