On July 15, 2020, FDA released a guidance regarding electronic submissions for medical devices as well as the FDA’s plans for implementing section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FDARA). The FDA has stated that additional details will be laid out in future related guidance documents. The released guidance in July follows a draft issued in September 2019. The guidance outlines the submissions that must be sent to FDA electronically via the eSubmitter and which may still be sent in hardcopy. This information will be helpful during regulatory strategy planning.
Types of submissions that must be submitted electronically:
- Premarket notification submissions (501k submissions)
- De Novo submissions
- Premarket approval applications (PMAs), including transitional and modular PMAs
- Product development protocols, investigational device exemption applications of all types
- Humanitarian device exemptions, Emergency Use Authorizations
- Certain investigational new drug (IND) applications such as those intended for use in screening donor blood
- Biological license applications (BLAs) regulated by CBER as biological products, regardless of whether an IND submission is required before the BLA submission
- Q-submissions (aside from pre-submissions) are not required in electronic format, but are recommended
- If an original submission had to be in electronic format, then the subsequent submission(s) must also be (even for single-page submissions)
Types of submissions that are not required to be submitted electronically (or may be exempt in future FDA guidance documents):
- Expanded access compassionate use requests
- Emergency use reports
- IDE Adverse event reports
Electronic submissions are still recommended!
Documents that do not fall under the requirements for electronic submission (voluntary submission will become an option):
- Master Access Files
- 513(g) requests for information
- Clinical laboratory Improvement Amendments of 1988 (CLIA) Categorization requests
- CLIA Waiver applications
The FDA has stated that future guidance documents will provide more information about specific electronic formats, subject matter, and scope of applicability regarding section 745A(b). they will also better explain the timeline for requiring electronic submission (based on submission type).
If you would like more information on the FDA’s framework for electronic submissions for medical devices or how this revised guidance may affect your company, please contact the FDA compliance experts here at MEDIcept.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.