#Use Ecopy How To Fix Errors
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For details on the eCopy program, including the technical standards for eCopies, refer to the eCopy guidance: eCopy Program for Medical Device Submissions (referred to as the eCopy Guidance on this page).Electronic Access assist that office in processing your 2012 ( 77 FR 63837 ). To access Help, select the connector in the ShareScan Administration console tree and then click the Connector Help button.An electronic copy (eCopy) is an electronic version of a medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. ECopy Quick Connect Help: Provides configuration and how-to information. The eCopy Connector for Quick Connect documentation set consists of the following documents: eCopy Quick Connect AdministratorвЂ™s Guide: This document.

You can even set preferences to require security for all.The technical standards for an eCopy are detailed in Attachment 1 of the eCopy guidance.eCopy TM ScanStation TM connects your color or black and white e-STUDIO MFP to your companyвЂ™s email and other networked applications for low-cost, easy, instantaneous distribution and management of scanned documents. Administrators can get ShareScan up and running in a matter of minutes with a visual workflow editor.Use the eCopy PaperWorks Save Secure option whenever you save a document or distribute it. It delivers all the capability necessary for business content workflows in one package that puts control in the hands of the user. Nuance В® eCopy ShareScan 6.0 brings power and flexibility to document capture workflows.

Use Ecopy Download The Mac

Use Ecopy How To Fix Errors

Always ensure you have downloaded and are using the most recent version of the validation module at the time you are planning to submit your premarket submission.Download the version of the eCopy Validation Module for your computerвЂ™s operating system:After you download the Mac version, review the ReadMeFirst.xls file before installing the application.Size: The FDA recommends that your total eCopy size be less than 1GB. The eSubmitter-eCopies Tool page includes a quick reference guide and video tutorials.This validation module checks for errors in your eCopy on the CD, DVD, or flash drive and advises you on how to fix errors before you submit the eCopy to the FDA.Important Note: The most recent validation module versions (for Windows and Mac) were released on November 20, 2020. From there, you can transfer the eCopy to CD, DVD, or flash drive to submit to the FDA. The tool guides you through the steps of adding the content and allows you to download a formatted eCopy onto a local drive. ECopy ShareScan delivers a peerlessly smooth experience, with easy-to-use workflow-simplifying buttons and on-screen document.The eSubmitter-eCopies Tool creates an eCopy in real time that is consistent with the technical standards described in the eCopy guidance.

Consider reducing the size of these files by using compression, lowering the resolution but still providing legible photos , or submitting only the necessary photos or portions of videos. Reduce the size of large files when possible: Many submissions include photos, x-ray images, and videos, which tend to be large files. Tips for reducing the total eCopy size include:

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The FDAвЂ™s loading software uses 3-digit prefix to load the PDFs in the order in which they will be read otherwise, the loading software would load the PDF files alphabetically. Examples can be found within the eCopy Guidance to maintain the submission order. If you have questions regarding whether a particular dataset should be included in your submission, contact the appropriate review division or contact the eCopy Coordinators at either 24 or Letter: For submissions to CDRH, you must attach a paper copy of your company cover letter (including a signature) to the eCopy (CD, DVD, or flash drive) but you are not required to include an electronic version of your company cover letter on the eCopy, since the FDA date-stamps and scans the paper copy of your company cover letter and places it in the official record.For submissions to the Center for Biologics Evaluation and ResearchвЂ™s (CBER) DCC, you are required to include the company cover letter (including a signature) within the eCopy (CD, DVD, or flash drive) instead of as a paper copy.PDF File Prefixes: The PDF files on the eCopy must begin with вЂњ001_вЂќ and continue to count consecutively.

For CDRH submissions, you must submit your eCopy with the accompanying paper copy of your company cover letter, including a signature, to the CDRH DCC.For CBER submissions, refer to вЂњ Electronic Submissions GatewayвЂќ or submit questions to Avoiding an eCopy HoldIf an eCopy contains errors, the FDA will place your submission on hold and email you an eCopy Hold notification correspondence. Submitting an eCopySend the eCopy version of your medical device submission to the CDRH Document Control Center (DCC) at this address:Center for Devices and Radiological HealthDocument Control Center (DCC) вЂ“ WO66-G609Note: You cannot submit an eCopy or an eCopy prepared using the eSubmitter-eCopies tool to CDRH through the Electronic Submission Gateway (ESG). It is recommended, but not required, that you use Descriptive Names that are consistent with the language used in published guidance documents, which will facilitate the review process by allowing the reviewer to easily navigate through the information. Look at the variety in the Descriptive Names throughout Attachment 1 of the eCopy guidance.Although there is flexibility in the Descriptive Name part of the file, it is important to use meaningful Descriptive Names for your PDF files so that the content of each file is clear to the FDAвЂ™s review staff.

PDF files that donвЂ™t comply with the naming convention. The most common errors that result in an eCopy hold are: Common eCopy ErrorsFor examples and exhibits of an eCopy, please view the eCopy guidance. We encourage you to check this page prior to submitting for the most recent validation modules. If your eCopy is not formatted correctly, the module generates a report of errors for you to fix prior to submitting your eCopy to the FDA.

The FDA date-stamps the company cover letter with the receipt date of your replacement eCopy. Missing company cover letters: For replacement eCopies, the FDA needs a paper copy of your company cover letter (including a signature) so that they can process the replacement eCopy. Note: There is currently no size limit for the overall eCopy. Check the size of each PDF on your CD, DVD, or flash drive to determine if it exceeds 50MB. Oversize PDF files: An individual PDF larger than 50MB will fail the loading process.

Instead, the PDF numbering starts back at 001_ and, if you have a volume-based submission, then the volume numbering starts back at VOL_001.If you receive an eCopy hold notification, please review the attachment page for the reasons it did not pass the validation process. You do NOT build your eCopy as a cumulative product for which you continue PDF or volume numbering, or try to match 3-digit prefixes that you assigned for the previous submission. You must start anew each time and create an eCopy that meets the technical standards of Attachment 1 in the eCopy guidance for the specific content that you want to submit. It does not matter if you are providing an original submission or a response to a deficiency letter. Issues from previous submissions: Each eCopy is its own entity.

For information on sending regulatory submissions to CBER, such as the current mailing address for CBERвЂ™s DCC, refer to CBERвЂ™s Regulatory Submissions вЂ“ Electronic and Paper. Contact for Questions about eCopyIf you have questions about the CDRH eCopy Program, contact the CDRH eCopy Program Coordinators at or 24. Always reference your document number and state it is a replacement eCopy on your company cover letter.

How To Use Ecopy