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.

The page contains a list of Frequently Asked Questions about 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.

Nov 16, 2025 · eCopy Desktop works with most network fax, e-mail and document management applications, including Lotus Notes, Microsoft Outlook/Exchange, Interwoven WorkSite, Lotus …

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.

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...

Oct 3, 2022 · You can send an eSTAR or eCopy to submit your 510 (k). After you submit your 510 (k) to the FDA, and when the FDA receives the 510 (k) submission, it assigns the submission a unique …

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

The eCopy hold notification will describe the reasons for the eCopy failure and the logistics for submitting a replacement eCopy. It is important that you follow these directions to avoid delays in …

At Ecopy Services, we simplify information management for healthcare providers and legal professionals. Our comprehensive suite of services streamlines your workflow, enhances security, …