Oct 3, 2022 · An electronic copy (eCopy) is an electronic version of your medical device submission. An electronic copy is not considered an electronic submission.

Dec 3, 2025 · This guidance provides information on the eCopy Program for medical device submissions.

Jan 14, 2026 · eCopy PaperWorks, now part of the Kofax imaging suite, is a robust document management solution designed to bridge the gap between paper-based workflows and digital efficiency.

Mar 25, 2021 · The U.S. Food and Drug Administration (FDA) provides several resources to help manufacturers prepare a valid electronic copy (eCopy) for medical device submissions.

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

The inclusion of an 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...

Dec 5, 2025 · Use CDRH’s Customer Collaboration Portal secure website to send eSTAR and eCopy premarket submissions and track progress of 510 (k) submissions online.

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eCopy enables mobile workforces to capture and process documents seamlessly so you can digitally transform workflows and increase productivity.

Dec 10, 2025 · Think of the eCopy (electronic copy) as the digital key to the FDA’s review door. The guidance clarifies that submission types like 510 (k)s, PMAs, and IDEs generally require an eCopy to …