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U.S. Department of Health and Human Services

Medical Devices

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eCopy Program for Medical Device Submissions

An electronic copy (eCopy) is an electronic version of your medical device submission stored on a compact disc (CD), digital video disc (DVD), or a flash drive. Including an eCopy with your submission has been required since January 1, 2013.  A submission with an eCopy that does not meet the technical standards outlined in the eCopy guidance will be placed on eCopy hold until a valid eCopy is received.

The following resources will help you in understanding the eCopy program and how to successfully create and submit your eCopy:

If you have questions about the eCopy program, please contact the eCopy Program Coordinators at CDRH-eCopyinfo@fda.hhs.gov or 240-402-3717.