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# Medical Device eCopy Submission Guidance
- URL: https://www.fdaweb.com/medical-device-ecopy-submission-guidance-2/
- Published: 2020-04-28T12:00:00.000Z
- Updated: 2026-09-14T16:12:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146669

FDA has issued a guidance, *eCopy Program for Medical Device Submissions*, to describe how the agency is implementing the eCopy Program for medical device submissions. The [document](https://www.fda.gov/media/83522/download?ref=fdaweb.com) says the FDA Safety and Innovation Act requires the submission of electronic copies with the issuance of this final guidance.

The guidance provides the standards for a valid eCopy. It says the act provides that submissions that do not include an eCopy and submissions that do not meet the guidance standards will be placed on hold until a valid eCopy is submitted to the agency and verified to meet the standards unless a waiver or exemption has been granted.

Guidance contents include Introduction, What is an eCopy?, For What Submission Types is an eCopy Required?, Are There Other Submission Types Not Subject to the eCopy Legislation for which eCopies May be Submitted?, How Many Copies of a Submission Are Needed?, What Are the Processing Steps for an eCopy?, What if You Device is Regulated by CBER?, and Technical Standards for eCopies.