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. 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).
On this page:
- Preparing an eCopy
- Submitting an eCopy
- Avoiding an eCopy Hold
- Common eCopy Errors
- Responding to an eCopy Hold
- Contact for Questions about eCopy
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 these two resources to submit and validate your eCopy.
The eSubmitter-eCopies Tool creates an eCopy in real time that is consistent with the technical standards described in the eCopy guidance. The tool guides you through the steps of adding the content and allows you to download a formatted eCopy onto a local drive. From there, you can transfer the eCopy to CD, DVD, or flash drive to submit to the FDA. The eSubmitter-eCopies Tool page includes a quick reference guide and video tutorials.
eCopy Validation Module
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. 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 computer’s operating system:
After you download the Mac version, review the ReadMeFirst.xls file before installing the application.
Tips for Preparing an eCopy
Size: The FDA recommends that your total eCopy size be less than 1GB. eCopies over 1GB may experience delays because additional time is needed to load them into the FDA’s database. Tips for reducing the total eCopy size include:
- Reduce the size of large files when possible: Many submissions include photos, x-ray images, and videos, which tend to be large files. 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.
- Divide information among different folders, CDs, or DVDs: Consider breaking down information into several different folders inside the MISC FILES or STATISTICAL DATA folders and/or placing these larger files on multiple CDs or DVDs. 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 240-402-3717 or [email protected].
Cover 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 Research’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 “001_” and continue to count consecutively. Examples can be found within the eCopy Guidance to maintain the submission order. The FDA’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. The FDA review staff does not see the 3-digit prefix after the submission is loaded into our official repository.
The prefix is assigned based on where that PDF file is in the sort order. In other words, if a PDF file was the 15th file in your list of PDFs to be reviewed on your eCopy, then that PDF must have a “015_” prefix. Note that there is no correlation between the 3-digit prefix and the content or section location of a file. For example, if a mechanical testing report PDF was in Section 10 of the document, this does not mean that the prefix of “010_” must be applied.
PDF File Names: Section C of the eCopy guidance describes the 3-digit prefix followed by an underscore that must appear immediately before the Descriptive Name part of the file. You may use any Descriptive Name as long as it does not have special characters. 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 FDA’s review staff. 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.
Send the eCopy version of your medical device submission to the CDRH Document Control Center (DCC) at this address:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Note: You cannot submit an eCopy or an eCopy prepared using the eSubmitter-eCopies tool to CDRH through the Electronic Submission Gateway (ESG). 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.
If an eCopy contains errors, the FDA will place your submission on hold and email you an eCopy Hold notification correspondence. An eCopy Hold will delay the review of your submission/application until the issue(s) are resolved.
The easiest way to avoid an eCopy Hold is to use the eCopy validation module to format your eCopy correctly and identify eCopy errors prior to submission. 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. We encourage you to check this page prior to submitting for the most recent validation modules.
For examples and exhibits of an eCopy, please view the eCopy guidance. The most common errors that result in an eCopy hold are:
- PDF files that don’t comply with the naming convention. For example, PDF files that do not begin with the file name (001_, 002_, 003_ etc.)
- Non-PDFs that were not zipped. These are Non-PDFs that were not zipped inside of the “MISC FILES” or “STATISTICAL DATA” folders.
- Non-PDFs that were not placed in the correct folder. These are Non-PDFs that were saved outside of the “MISC FILES” or “ STATISTICAL DATA” folders.
- Volume names that contain unacceptable symbols. The list of acceptable symbols can be found in the eCopy guidance.
Other errors include:
- Oversize PDF files: An individual PDF larger than 50MB will fail the loading process. Check the size of each PDF on your CD, DVD, or flash drive to determine if it exceeds 50MB. Note: There is currently no size limit for the overall 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. The FDA date-stamps the company cover letter with the receipt date of your replacement eCopy. In other words, you need to resubmit a company cover letter with every replacement eCopy.
- Issues from previous submissions: Each eCopy is its own entity. It does not matter if you are providing an original submission or a response to a deficiency letter. 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. 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. 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. Once you’ve made the corrections, run it against the eCopy Validation Module to ensure your response is accepted. Always reference your document number and state it is a replacement eCopy on your company cover letter.
If you have questions about the CDRH eCopy Program, contact the CDRH eCopy Program Coordinators at [email protected] or 240-402-3717 .
For information on sending regulatory submissions to CBER, such as the current mailing address for CBER’s DCC, refer to CBER’s Regulatory Submissions – Electronic and Paper. If you have questions about regulatory submissions to CBER, contact them at 1-800-835-4709 or [email protected].