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What is Ecopy?

An electronic copy (eCopy) is an electronic version of your medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. An eCopy is accompanied by a paper copy of the signed cover letter.

NOTE

Copy is not considered to be an eSubmission, which is a submission package produced by an electronic submission template. 

While an eCopy consists of only electronic documents that are human-readable, an eSubmission contains documents intended for computer processing as well as human-readable documents

What submission types is an eCopy required?

  • Premarket notification submissions (510(k)s), including third party 510(k)s;
  •  Evaluation of automatic class III designation petitions (de novos);
  •  Premarket approval applications (PMAs), including Transitional PMAs;
  • Modular PMAs;
  • Product development protocols (PDPs);
  • Investigational device exemption (IDE) submissions

Etc…

EXEMPTIONS:

Above, FDA identified the submission types cited in the legislation as being subject to the eCopy requirements. However, the legislation also allows for FDA to set forth criteria for exemptions from eCopy requirements. Accordingly, due to the potentially urgent nature of the following types of submissions, FDA considers these to be exempt from the requirement for an eCopy:

  • Three specific types of IDE submissions: compassionate use submissions, emergency use reports11, and adverse event reports; and
  • All EUAs.

What are the processing steps for an eCopy?

Meets the requirements of  technical standards 

The technical standards for an eCopy are detailed in Attachment 1. If it does not meet the technical standards in Attachment 1 will not be accepted. If it is not accepted, the file will be placed on hold until a valid replacement copy is provided  

There is a free eSubmitter-eCopies tool available on FDA’s website. The tool

guides you through the steps of adding the content and will add any required prefixes to volumes/folders and PDFs.

Packing submission file

          Snapshot of final packaging screen from eSubmitter-eCopies tool 

Recommended methods for creating an eCopy  

  • Bookmarks and Hyperlinks within PDFs  
  • Creating a PDF File from the Source Document (Preferred)  
  • Creating a PDF File from a Scanned Document  

Issues to consider when choosing the eCopy media: 

It is up to each applicant whether to burn your own version onto a CD, DVD, or flash drive.

However, please be aware that certain brands of media, particularly flash drives, come preloaded with files that may lead to your version failing the loading process.

NOTE:

      • Should your submission exceed the size of a standard CD, the FDA recommends that you use a DVD or flash drive, which has greater storage space, rather than split up your eCopy across multiple CDs.  
      • Submit  to FDA  
      • Attach a paper copy of your signed company cover letter CD, DVD, or flash drive, and send that package to CDRH’s or CBER’s Document Control Center (DCC).
      • For Third Party 510(k)s, refer to Section VI.f. for the specifics and company cover letter associated with each of the two parties involved.

FDA process an eCopy

The determination as to whether or not an eCopy passes the loading process will be made by the appropriate staff at the same time the submission is received by FDA and logged into our database  

Timeframes need to be considered  

If you are submitting a new submission and receive a hold notification, you should respond to that eCopy hold notification within 180 days. If FDA does not receive a replacement  within 180 days of the eCopy hold notification, FDA may consider your submission withdrawn and closed in our database.

If you are submitting a response to a review hold notification (e.g., a response to an

Additional Information letter for a 510(k)), you should allow for mail delivery and eCopy processing times in order to ensure that you meet review hold notification deadlines. You risk withdrawal and closure of your submission if your response is mailed very close to or at 180 day

Basic steps for developing an eCopy are as follows  

  • Determine the content of your document (original, supplement, amendment, or report). This is not dictated by the eCopy program  
Pre-Submission for which all content was was placed in a single PDF

         Pre-Submission for which all content was was placed in a single PDF

 

PMA annual report for which all content was was placed in a single PDF

        PMA annual report for which all content was was placed in a single PDF

 

Original 510(k) submission for which all content was placed in a single PDF

Original 510(k) submission for which all content was placed in a single PDF

  • Create your company cover letter following the specific requirements in Section A. Make sure your company cover letter includes a signature  
  • Based on the content, determine whether you want to have a volume-based or nonvolume-based structure for your eCopy. This determination is made independently for each eCopy and is not dependent on the format chosen for any previous document. 
  • Create your PDFs and add them to the eCopy. PDFs are the main file type, if not the only file type, that comprises your eCopy. Please note that PDFs should be created by converting the files from the original (native) format (e.g., Microsoft Word) using Adobe Acrobat PDF Version 11 or below whenever possible, rather than creating them as scanned versions of the printed files, which are far inferior in quality.  
  • If you need to add non-PDFs to your eCopy, follow the instructions in Section D. NonPDF files are added by zipping them and placing the zip file(s) under a “MISC FILES” or “STATISTICAL DATA” folder. Do not place any PDFs in either of these two folders. Please note that it is preferable that statistical data be provided in a structured format readable by common statistical analysis software packaging
  • Prepare your package for DCC. The package includes: (1) your eCopy burned to a CD, DVD, or flash drive with a paper copy of your signed company cover letter as described in Section A below  .
  • Mail your package to the DCC.
Original 510(k) submission for which the content was added as individual PDF files

Original 510(k) submission for which the content was added as individual PDF files

 

Response to 510(k) RTA hold letter for which each item being responded to was added as an individual PDF file

                    Response to 510(k) RTA hold letter

PDF File Requirements

Whether you choose a volume-based or non-volume-based eCopy structure, PDF is the primary file format used for an eCopy. (See Section D for how to add non-PDF files to an eCopy.)

Below are the requirements for PDF files. If you do not follow them, your eCopy will fail the loading process.

Specific PDF File Naming Convention

You must use the following naming convention for all PDF files, whether part of a volume-based or non-volume-based eCopy:

 xxx_Descriptive Name

The PDF file name has a non-repeating, consecutive 3-digit number prefix followed by

an underscore (_). The first PDF has the prefix of 001_, the second PDF has a prefix of

002_, etc.  

ECopies that are comprised of only a single PDF need to have the 3-digit prefix of 001_.

No Embedded Attachments or Attributes  

Do not confuse embedded attachments or attributes with hyperlinks or bookmarks, as these are very different. Hyperlinks and bookmarks are not only permitted but are also encouraged because they facilitate navigation of the submission by the reviewer; they are described in above.

No PDFs that Require a Password to Open  

We previously rejected PDF files with any type of security setting that met either of the following two scenarios: (1) security settings that allowed anybody to open the file but protected the content from modification (which appears to be a common practice with independent laboratories) and (2) security settings that required passwords to open them.  

PDF File Size Limited to 50MB or Below  

PDF that has exceeded the 50MB size limit and will fail the eCopy loading process

PDF that has exceeded the 50MB size limit and will fail the eCopy loading process

 

Example of how you can split and label a PDF greater than 50MB into multiple files

                                              Split and label a PDF greater than 50MB

 

Adobe Acrobat PDF Version 11 or B  

Requirements for How to Add Non-PDFFiles via “STATISTICAL DATA” and “MISC FILES” Folders  

Section B describes how both a volume-based and non-volume-based eCopy includes PDF files. However, in addition to PDF files, an eCopy may also include non-PDF files, if applicable for a particular submission  

  • The three required steps for adding non-PDF files to an eCopy are as follows:  
  • Add a “STATISTICAL DATA” or “MISC FILES” folder to the root level of the eCopy. These folders must be spelled precisely, but they are not case sensitive.  
  • Zip all non-PDF content into one or more zip file(s). There are no limitations/restrictions on the naming convention for a zip file(s) or any of the content that you add to the zip file(s). In addition, there Vertical vs. horizontal standards
  • is no size limit for a zip file.  
  • Statistical data, videos, and images (e.g., CTs, x-rays) are typically large files  
  • Add the zip file(s) to the “STATISTICAL DATA” or “MISC FILES” folder.  

NOTE:

Depending on the type of non-PDF files that you want to add , you may determine that it is appropriate to have both the “STATISTICAL DATA” and “MISC FILES” folders.

 

Source: FDA guidance: ” Ecopy program for medical device 510 (k) submission”

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