eCopy Medical Device Submissions
Send Medical Device eSTAR and eCopy Premarket Submissions Online
October 3, 2022 - The FDA is announcing that you may now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal ("CDRH Portal").
Building on the progress tracker for 510(k) submissions launched in 2021 and the trial process of electronic uploads launched in July 2022, the CDRH Portal now allows anyone to register for a CDRH Portal account to send CDRH eCopy or eSTAR premarket submissions online.
Starting October 1, 2023, all 510(k) submissions, unless exempted*, must be submitted as electronic submissions using eSTAR.
An electronic copy (eCopy) is a duplicate device submission in electronic format of the previously required paper copy submission sent to the FDA. An electronic copy is not considered an electronic submission.
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).
An eCopy is required for the submission types listed in Section III. "For what submission types is an eCopy required?" in the eCopy guidance.
For information about the electronic Submission Template And Resource (eSTAR), see the Voluntary eSTAR Program web page on FDA.gov.
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
Preparing an 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 the resources below 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 eSubmitter-eCopies Tool page includes a quick reference guide and video tutorials. 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 send an eCopy to the FDA.
eCopy Validation Module
The validation module checks for errors in your eCopy and advises you on how to fix errors before you submit the eCopy to the FDA.
Mac Users: The current validation module for Mac is not compatible with Apple computers that have any variation of the M1/M2 processors. An updated version to support the new Apple processors is in development.
Windows and Mac Users: 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:
- Download Windows 64-Bit Version
- Download Windows 32-Bit Version
- Download Mac Version
- After you download the Mac version, review the ReadMeFirst.xls file before installing the application.
Tips for Preparing an eCopy
eCopy File Size
Size: The FDA recommends 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 CDRH-eCopyinfo@fda.hhs.gov.
PDF Naming Conventions
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.
Format a USB drive
Format your USB to the exFAT file system:
In Microsoft Windows
- Insert the USB drive into a port
- Open File Explorer and choose This PC
- In Devices and drives, right-click the USB drive and choose Format
- File system: choose exFAT
- Volume label: enter a name for your drive
- Format options: choose Quick format
- Choose Start, then OK
In Apple Mac OS
- Insert the USB drive into a port
- Open Disk Utility and choose View > Show All Devices
- Choose the USB drive
- Choose Erase
- Name: enter a name for your drive
- Format: choose ExFAT
- Choose Erase, then Done
Submitting an eCopy
Send eCopy premarket submission online through the CDRH Customer Collaboration Portal (CDRH Portal):
Starting October 1, 2023, all 510(k) submissions unless exempted* must be submitted as electronic submissions using eSTAR.
*As noted in the final guidance, Electronic Submission Template for Medical Device 510(k) Submissions, all 510(k) submissions including original submissions for Traditional, Special, and Abbreviated 510(k)s, and subsequent Supplements and Amendments and any other subsequent submissions to an original submission, unless exempted in Section VI.A Waivers and Exemptions From Electronic Submission Requirements of the guidance, are required to be submitted as electronic submissions. The electronic submission template, eSTAR, is the only currently available electronic submission template to facilitate the preparation of 510(k) electronic submissions.
Note: The FDA only intends to accept 510(k) submissions saved to a form of electronic storage media and mailed to the FDA if they are received by the FDA before October 1, 2023. For more information, see the guidance document, Electronic Submission Template for Medical Device 510(k) Submissions.
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
For hand deliveries (in person) to the CDRH White Oak Campus building 66, please contact 301-796-6597 for instruction.
For mailed CDRH submissions, you must submit your eCopy to the CDRH DCC.
For CBER submissions, refer to Regulatory Submissions in Electronic and Paper Format for CBER-Regulated Products, Electronic Submissions Gateway, or submit questions to ESUBPREP@fda.hhs.gov.
Note: You cannot submit an eCopy or an eCopy prepared using the eSubmitter-eCopies tool to CDRH through the Electronic Submission Gateway (ESG).
Avoiding an eCopy Hold
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 review of your submission 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.
Common eCopy Errors
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.
- 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, including an updated cover letter. 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.
Responding to an eCopy Hold
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 the eCopy Validation Module again to ensure your response is accepted. Always reference your document number and state it is a replacement eCopy on your company cover letter.
Contact for Questions about eCopy
If you have questions about the CDRH eCopy Program, contact the CDRH eCopy Program Coordinators at CDRH-eCopyinfo@fda.hhs.gov.
For information on sending regulatory submissions to the Center for Biologics Evaluation and Research (CBER), such as the current mailing address for CBER's DCC, refer to CBER's Regulatory Submissions in Electronic and Paper Format for CBER-Regulated Products. If you have questions about such regulatory submissions, contact CBER at 1-800-835-4709 or Industry.Biologics@fda.hhs.gov.