WebOct 3, 2024 · An electronic copy (eCopy) is an electronic version of your medical device submission. An electronic copy is not considered an electronic submission. WebOct 30, 2024 · The tool is separate from the eCopy ShareScan installation, and can be launched by starting CertificateManager.exe. This tool is included in the Tools directory for ShareScan 5.1 and newer. How to use it: When started, the Certificate Manager displays the following buttons in its window; depending on your configuration, the first option ...
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If an eCopy contains errors, the FDA will place your submission on hold and email you an eCopy Hold notification. An eCopy Hold will delay the … See more The technical standards for an eCopy are detailed in Attachment 1 of the eCopy guidance. To prepare an eCopy that meets the technical standards – and to avoid eCopy errors or an eCopy hold – use the resources … See more For examples and exhibits of an eCopy, please view the eCopy guidance. The most common errors that result in an eCopy hold are: 1. … See more WebThe eCopy Highlight and Redact Extender service is the process component in the Capture > Process > Store workflow of ShareScan: it lets you apply highlight or cross-out markings to the output document and do secure scanning of confidential documents by redacting ("blacking out") sensitive information. check running programs cmd
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WebNov 8, 2013 · An eCopy in response to a 510(k) hold notification should only include the response content. ... The FDA recommends that submitters check eCopies against an online validation tool before filing them. Attachment 1 in the updated guidance includes an overview on “basic steps for developing an eCopy” and provides details on the individual ... Webapplications in eCopy using a free eSubmitter-eCopies tool on FDA’s website 4. SI staff determines if an eCopy on the CD , DVD or flash drive meets the technical standards using the free eCopy Validation Module 5 Investigator choses the eCopy media (CD , DVD or flash drive) then save 6. Investigator attaches a paper copy of signed cover letter to WebOct 12, 2024 · Consider using the FDAs eSubmitter-eCopies Tool (voluntary) to format your eCopy content. The eCopy Validation tool is a downloadable software that can help … flat plate natural convection time to cool