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.
What You Need to Know? 👇
What medical device submissions must be submitted solely in electronic format under Section 745A(b)?
Section 745A(b) requires electronic submission for 510(k)s, De Novos, PMAs, IDEs, HDEs, EUAs, certain INDs/BLAs for CBER-regulated devices, and pre-submissions. This includes all amendments, supplements, and reports to these original submissions.
When will FDA require electronic submissions for medical devices?
FDA will issue individual guidance documents specifying electronic formats and implementation timelines for each submission type. Requirements become binding once final guidance is published and the specified implementation date passes. The process allows for phased implementation.
Are there any exemptions from electronic submission requirements for medical device submissions?
Yes, expanded access compassionate use requests and adverse event reports for IDE submissions are exempt. However, FDA encourages voluntary electronic submission of these types when templates become available to facilitate review.
Will FDA provide waivers from electronic submission requirements?
FDA may establish waiver criteria, which will be detailed in individual guidance documents for specific submission types. The statute authorizes FDA to set forth such criteria, but specifics depend on the submission type.
How will FDA implement the electronic submission requirements for different device types?
FDA will release sequential draft guidance documents specifying electronic formats for each submission type, publish Federal Register notices for comment periods, finalize guidance after reviewing comments, and announce implementation dates with adequate transition time.
What happens if I submit a medical device application in paper format when electronic is required?
Submissions not in the required electronic format will not be filed or received by FDA, unless specifically exempted from electronic requirements or granted a waiver. All submissions must comply with the specified electronic format once implemented.
What You Need to Do 👇
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:
- Master Access Files
- 513(g) Requests
- CLIA categorization requests and waiver applications
Relevant Guidances 🔗
- 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.