An electronic copy (eCopy) is a duplicate device submission in electronic format of the previously required paper copy submission sent to the FDA. An electronic copy is not considered an...

The page contains a list of Frequently Asked Questions about the eCopy program for medical device submissions.

This guidance explains the eCopy Program for medical device submissions as well as implementation of this program by the FDA.

An eCopy is a digital version of your submission that contains the same content and format as the paper version. An eCopy allows the FDA to process and review the submission more efficiently, as well as facilitate electronic archiving and retrieval of …

2013年1月2日 · An eCopy is defined as an exact duplicate of the paper submission, created and submitted on a compact disc, digital video disc, or flash drive, accompanied by a copy of the signed cover letter and the complete paper submission.

2022年11月11日 · Q1: What is eCopy? A1: According to the FDA, an electronic copy is a duplicate device submission in electronic format of the previously required paper copy submission sent to FDA. An electronic copy is not considered to be an electronic submission (eSubmission).

2020年1月5日 · The eCopy guidance that was current in 2018 stated that you should include the following phrase in your cover letter: “This submission includes an eCopy and a paper copy. The eCopy is an exact duplicate of the paper copy.”

eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version. This guidance provides, among other things, the standards for a valid eCopy under section

2022年11月24日 · What is an eCopy? An eCopy is an electronic version of your medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or flash drive. An eCopy is accompanied by a paper copy of the signed cover letter.

2013年11月3日 · An eCopy is “an exact duplicate of the paper submission,” and not an electronic submission. Id. at 2. Generally, the key things to remember when preparing an eCopy are: The eCopy must be submitted on a CD, DVD or flash drive along with …