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U.S. Department of Health and Human Services

Medical Devices

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eCopy Program - Updated

November 4, 2013

On October 30, 2013, the FDA updated the eCopy Program webpage with an instructional video on how to submit an eCopy. The goal of the video is to help applicants learn how to format and submit an eCopy and address frequently asked questions.

Since January 1, 2013, applicants have been required to provide an electronic copy (eCopy) of their medical device submissions along with their paper copy. The eCopy Program has improved the review process by allowing the immediate availability of an electronic version of a medical device submission for review by FDA staff.

If you have questions about the eCopy program, please contact the eCopy Program Coordinators at

 CDRH-eCopyinfo@fda.hhs.gov or 240-402-3717.

Thank you for your support of the FDA and its mission.


Center for Devices and Radiological Health Food and Drug Administration