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.
Recommended Actions
- Review the list of submission types requiring electronic format to identify which apply to your organization
- Monitor FDA website for individual guidance documents specifying electronic formats for specific submission types
- Plan for transition to electronic submissions according to the timetables that will be specified in individual guidances
- Establish internal processes to ensure compliance with electronic submission requirements
- For exempt submissions, consider voluntary electronic submission to facilitate review process
- Monitor Federal Register notices for updates on new or revised electronic submission requirements
- Ensure capability to submit in required electronic format before mandatory implementation dates
- Consider requesting waivers if needed, based on criteria that will be specified in individual guidances
Key Considerations
Other considerations
- Mandatory electronic submission for:
- 510(k) submissions
- De Novo requests
- PMA applications and supplements
- Modular PMAs
- Product Development Protocols
- IDE applications and reports
- HDE applications
- Emergency Use Authorizations
- Certain INDs and BLAs (CBER-regulated devices)
- Pre-submissions
- Exemptions granted for:
- Expanded access compassionate use requests
- Emergency use reports
- Adverse event reports
- Voluntary electronic submission recommended for:
- Electronic Submission Template And Resource (eSTAR) for 510k Submissions
- Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
Related references and norms
No specific norms or standards referenced in this guidance.
Original guidance
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