eCopy Medical Device Submissions | FDA
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.
eCopy Program for Medical Device Submissions: Frequently Asked ...
The page contains a list of Frequently Asked Questions about the eCopy program for medical device submissions.
eCopy Program for Medical Device Submissions | FDA
This guidance explains the eCopy Program for medical device submissions as well as implementation of this program by the FDA.
E-Copy Services
At Ecopy Services, we simplify information management for healthcare providers and legal professionals. Our comprehensive suite of services streamlines your workflow, enhances security, …
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...
eCopy PaperWorks for Windows - CNET Download
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.
Send and Track Medical Device Premarket Submissions Online
Sep 30, 2025 · Use CDRH’s Customer Collaboration Portal secure website to send eSTAR and eCopy premarket submissions and track progress of 510 (k) submissions online.
eCopy Desktop Download - It enables office workers to easily and ...
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 …
eCopy Program for Medical Device Submissions: Guidance for Industry …
Nov 30, 2024 · Return to Search eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff Download the Guidance Document
Get the eCopy Validation Module for Medical Device Submissions
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.