Medical Device eCopy Submission Guidance

FDA has published a guidance, eCopy Program for Medical Device Submissions, describing how the agency is implementing the eCopy program under the FDA Reauthorization Act of 2017. The document says the eSTAR program is the current program for submissions solely in electronic format. But until eSTAR is implemented for each specific submission type, the eCopy program must be used. FDA says those two programs plus two other electronic submission programs “are expected to improve efficiency of the review process by allowing for more timely availability of submission content rather than relying solely on delivery, processing, and maintenance of a paper version.”

The guidance contains an Introduction, What is an eCopy?, For what submission types is an eCopy required?, Are there other submission types not subject to eCopy for which eCopies may be submitted?, What if your device is regulated by CBER?, and four attachments.