eCopy Medical Device Submissions
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. A table summarizing requirements by submission types is provided on this web page, below.
For information about the electronic Submission Template And Resource (eSTAR), see the eSTAR Program web page on FDA.gov.
On this page:
- When an eCopy is Required
- Preparing an eCopy
- Submitting an eCopy
- Avoiding a Format Hold
- Common eCopy Errors
- Responding to a Format Hold
- Contact for Questions about eCopy
When an eCopy is Required
In accordance with Section 745A(b) of the FD&C Act, an eCopy is required for the following submission types, except those (1) accepted or required through the eSTAR Program or (2) exempt from the requirements.1 The following table identifies, by submission type, whether submission as an eCopy or eSTAR is required or voluntary. Although eCopy and/or eSTAR is not required for certain submission types, FDA accepts and encourages you to submit eCopies (or, where available, eSTARs) for these submission types. Additionally, while certain submission types are exempt from the requirements under section 745A(b)(1), FDA encourages submission of eCopies of these submissions, when feasible, in order to facilitate the review process.
Note: An eCopy is required for appeals of submission types for which an eCopy or eSTAR is required.
| Submission Type2 | Electronic Submission Format |
|---|---|
| 510(k)s, including Third Party 510(k)s | eSTAR (required after 10/1/2023 unless exempted)3 |
| De Novos | eSTAR (required after 10/1/2025 unless exempted)4 |
The following PMA applications and supplements:
| eCopy (required) or eSTAR (voluntary*) |
All other PMA submission types
| eCopy (required) |
| Product Development Protocols (PDPs) | eCopy (required) |
Humanitarian Device Exemptions (HDEs)
| eCopy (required) |
| Pre-Submissions | eCopy (required) or eSTAR (voluntary*) |
All other Q-Submission types
| eCopy (voluntary*) |
| IDE original applications and supplements, except for expanded access compassionate use requests | eCopy (required) or eSTAR (voluntary*) |
| IDE expanded access compassionate use requests | eCopy (voluntary*) or eSTAR (voluntary*) |
| IDE expanded access compassionate use or emergency use reports, and adverse event reports | eCopy (voluntary*) |
| All other types of IDE reports | eCopy (required) |
| Investigations New Drug Applications (INDs) | eCopy (required) |
Biologics License Applications (BLAs) and associated amendments
| eCopy (required) |
| Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization requests (CLIA Record; CR) and CLIA Waiver Applications (CWs) | eCopy (voluntary*) |
| 513(g)s | eCopy (voluntary*) or eSTAR (voluntary*) |
| Master Access Files (MAFs) | eCopy (voluntary*) |
| Emergency Use Authorizations (EUAs)5 | eCopy (voluntary*) |
1For more information on providing regulatory submissions in electronic format, see FDA’s guidance “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.” For more information about eCopy requirements and exemptions see FDA’s guidance “eCopy Program for Medical Device Submissions.”
2Amendments are not addressed in this table. For additional information about amendments, refer to the available eCopy and submission-specific eSTAR guidances.
3See FDA’s guidance “Electronic Submission Template for Medical Device 510(k) Submissions”
4See FDA’s guidance “Electronic Submission Template for Medical Device De Novo Requests”
5See section D.3. of the FDA guidance “Emergency Use Authorization of Medical Products and Related Authorities” for the email address where EUAs can be sent.
*Although eCopy and/or eSTAR is not required, FDA accepts and encourages you to submit eCopies (or, where available, eSTARs) for these submission types.
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 a format hold – use the resources below to submit and validate your eCopy:
eSubmitter-eCopies Tool
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.
Note: Only CDRH submissions may be sent through the CDRH Portal. For biologic products or devices used in blood establishments, please submit to the Center for Biologics, Evaluation, and Research (CBER).
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 4GB. eCopies over 4GB 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.
Note: For Electronic Submissions Gateway Next Generation (ESG NextGen), please refer to https://www.fda.gov/industry/getting-started-esg-nextgen/center-submission-types for information regarding file size requirements.
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: Attachment 1, 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
Online:
Send eCopy premarket submission online through the CDRH Customer Collaboration Portal (CDRH Portal):
Mail:
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, ESG NextGen, 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 ESG NextGen.
Avoiding a Format Hold
If an eCopy contains errors, the FDA will place your submission on hold and email you a format hold notification. A format hold will delay the review of your submission until the issue(s) are resolved.
The easiest way to avoid a format 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 a format 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 a Format Hold
If you receive a format 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.