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.