November 24, 2022
Key Considerations for Successful Creation and Submission of a 510(k) eCopy

What is an eCopy?

An eCopy is an electronic version of your medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or flash drive. An eCopy is accompanied by a paper copy of the signed cover letter. It is to be noted that an eCopy is not the same as a Food and Drug Administration (FDA) electronic submission [PKJ1]. Following are submissions that require an eCopy:

  • Pre-Market Notification (PMN) submissions (510(k)) including third party 510(k)s
  • Evaluation of automatic class III designation petitions (De Novos)
  • Pre-Market Approval (PMA) applications, including Transitional PMAs and Modular PMAs
  • Product development protocols (PDPs)
  • Investigational device exemption (IDE) submissions
  • Humanitarian device exemption (HDE) submissions
  • Emergency Use Authorizations (EUAs)
  • Certain investigational new drug applications (INDs)
  • Certain biologics license applications (BLAs)
  • Q-submissions

How to Create a Successful eCopy?

There are certain technical standards written into the FDA eCopy software coding. If the detailed standards are not met, then the eCopy does not pass through the FDA’s eCopy loading process. Below are the basic steps for the creation of an eCopy, as detailed in the FDA eCopy guidance.

  • Determine the content of the document
  • Create a company cover letter following the specific requirements as in Section A of the FDA guidance [PKJ2] [H3]and ensure that the company cover letter includes a signature
  • Based on the content of the document, determine if a volume or non-volume-based structure is needed. The determination is made independently for each eCopy.
    • In case of a volume-based submission, add the volumes to eCopy following the naming convention as outlined in Section B [PKJ4] [H5] of the FDA guidance
  • Create a PDF and add them to the eCopy. There are some PDF dos and don’ts to be followed concerning naming conventions and formats.

Dos

  • PDFs are to be converted from the original format ( e.g., Microsoft Word) using Adobe Acrobat PDF version 11 or below
  • For naming conventions, one can refer to Section C [PKJ6] [H7] of the FDA guidance document
  • PDFs can only be added at the main level (the level seen when one opens a CD, DVD, or a flash drive) of the eCopy or under a volume/folder
  • If it is a volume-based submission, PDFs are to be named with a prefix starting with”001_” in each volume
  • If it is a single PDF, then it must have a “001_” prefix
  • eCopy size preferably less than 1 GB to avoid possible delays (can avoid by reducing the size of large files or divide information [PKJ8] among different folders)

Don’ts

  • Embedded attachments
  • Security settings
  • 50 MB or smaller in size
  • Creating PDFs from scanned versions of printed files as they are of inferior quality
  1. If non-PDFs need to be added to the eCopy, please follow the instructions outlined in Section D of the guidance. Non-PDFs are added in a zip file under the “MISC FILES” or STATISTICAL DATA” folder [PKJ9]. Do not place any PDFs in either of these folders.
  2. Prepare a package that will include
    • eCopy burned to CD, DVD, or a flash drive
    • A paper copy of the signed company cover letter as described in Section A

How to Submit an eCopy?

eCopies can be submitted either online or mailed to the Document Control Centre (DCC).

  • Online submissions can be sent through the CDRH Customer Collaboration Portal or the CDRH Portal.
  • eCopy submissions can be mailed to the DCC at the following 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

*Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR.

What is an eCopy Hold and How to Avoid it?

An eCopy hold is a notification issued by the FDA if the eCopy has the error(s). The review of the submitted eCopy will be put on hold until the issue(s) are resolved. The reasons for the hold are mentioned in the attachment page of the notification.

The simplest way to avoid an eCopy hold is to use the FDA eCopy validation module (the downloadable versions for both Windows and Mac are available on the FDA site), which helps to format the eCopy correctly and identify errors before submission. In case of formatting errors, the module will generate a report to resolve the errors before the final submission of the eCopy to the FDA [PKJ10] [RH11].

An eCopy is required for nearly all medical device submissions, including 510(k)s, de novo petitions, PMAs, IDEs, HDEs, and pre-submissions. Therefore, it is prudent that a medical device manufacturer is thoroughly acquainted with the process of creation and submission of an eCopy.

For more information or assistance with the eCopy creation and submission process, FDA’s 510(k) process or even end-to-end global Regulatory support, contact Freyr! Stay informed. Stay compliant.