eCopy Program for Medical Device Submissions


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