Certain medical devices must provide an electronic copy (eCopy) of their submission. An eCopy is a duplicate of the paper copy that is submitted to the FDA, and may be submitted on a CD, DVD, or flash drive. The purpose of an eCopy is to improve the review process by making a submission available immediately. The updated guidance document “eCopy Program for Medical Device Submissions” was released on December 3, 2015. Some of the changes to the guidance include: explanation of the importance of bookmarks and hyperlinks, gives details on creating a PDF file from the source document, emphasizes the use of the eCopy Validation Module and the eSubmitter-eCopies Tool.
An eCopy is required for the following submission types:
- Premarket notification submissions
- Evaluation of automatic class III designation petitions
- PMAs
- Modular PMAs
- Product development protocols
- IDEs
- HDEs
- Emergency Use Authorizations
- Certain investigational new drug applications
- Certain biologics license applications
- Q-submissions