- Technical Standards for an eCopy - Your eCopy must meet the technical standards outlined in Attachment 1 of the eCopy guidance. If your eCopy does not meet the technical standards, it will fail the loading process.
- eCopy Hold Letters - If your eCopy fails the loading process, you will receive an eCopy hold letter that states the specific reason(s) for the failure. You are required to submit a replacement eCopy that addresses the reason(s) identified in your eCopy hold letter.
- General Questions
Where can I find the technical standards for an eCopy?
Refer to the eCopy guidance. The first part of the guidance describes the eCopy program and Attachment 1 of the guidance describes the technical standards.
Should I use the volume-based eCopy structure or the non-volume based eCopy?
You can use either structure for your eCopy.
- The non-volume-based structure is recommended for small submissions. See Figures 2 through 8 in the eCopy guidance for examples.
- The volume-based structure is more suitable for larger submissions. See Figures 9 through 11 in the eCopy guidance for examples.
Can my eCopy be a single PDF file?
Yes. Whether an original, supplement, report, or amendment, you can have a single PDF that comprises your eCopy. Make sure you follow the PDF naming convention for that file name by starting with the “001_” prefix. Also, make sure that your PDF does not exceed 50MB.
What are the most common errors made by applicants regarding the technical standards?
The three most common errors for eCopy failure are:
- The PDF file naming convention was not valid (Refer to Section C of the eCopy guidance).
- The volume/folder naming convention was not valid (see Section B of the eCopy guidance).
- Non-PDF files were not added to the eCopy in a valid manner (see Section D of the eCopy guidance).
What are basic naming conventions for PDFs and Volumes?
As shown below, PDF and Volume naming conventions are different.
Volume naming conventions
- VOL_XXX_Descriptive Name (e.g., VOL_001_Patient Study Data); or
- VOL_XXX (e.g., VOL_001)
PDF naming convention
- XXX_Descriptive Name (e.g., 001_Cover Letter, 002_MDUFA Form)
Please see Sections B and C of the eCopy guidance for more details on the naming conventions for volumes and PDFs, respectively.
Do I have to name my PDF files the same way FDA does in the examples in 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.
Please note that although there is flexibility in the Descriptive Name part of the file, it is important that you have a meaningful Descriptive Name for your PDF file so that the content of the file is clear to review staff. It is recommended, but not required, that you use Descriptive Names that are consistent with the language used in published guidance documents. This will facilitate the review process by allowing the reviewer to easily navigate through the information.
What is the purpose of the 3-digit prefix in a PDF file name?
Each PDF file in an eCopy must begin with a 3-digit prefix followed by an underscore (“_”) and then the Descriptive Name. The 3-digit prefix is only used to load the PDFs in the order in which they will be read; otherwise, the loading software would load the PDF files alphabetically. The first file that is to be read has the 001_ prefix. The second file to be read has the 002_ prefix, etc. The 3-digit prefix is solely used by our loading software to put your PDFs in review order. The 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.
What must I include in my company cover letter in order to meet eCopy requirements?
For the purpose of eCopy processing, the Document Control Center (DCC) will evaluate your company cover letter determine if it includes both an eCopy statement and a signature. Both of these elements must be included in your company cover letter for each submission you mail to the DCC. If your company cover letter does not include these two elements, your submission will be placed on eCopy hold.
An eCopy statement in your company cover letter is required because it states that the paper and eCopy versions match. This is essential because the lead reviewer and any consultant(s) may use one or both versions to perform their regulatory review of your submission. The eCopy statement used by most applicants is as follows: “The eCopy is identical to the paper copy.” Refer to Section A of the eCopy guidance for more information about the eCopy statement.
Please note that the company cover letter must not be confused with FORM FDA 3514 (CDRH Premarket Review Submission Cover Sheet). Your company cover letter is a document on your letterhead that typically includes the purpose of your submission and contact information (including phone number and email address), along with the required eCopy statement and signature.
Do I have to save my company cover letter as a PDF on my eCopy?
No, including an electronic version of your company cover letter on the eCopy is not required. This is because FDA date-stamps and scans in the paper copy of your company cover letter and places it in the official record. But, as explained above, you must attach a paper copy of your company cover letter (including an eCopy statement and signature) to the eCopy (CD, DVD, or flash drive).
How do I structure my eCopy when responding to a deficiency letter (e.g., RTA Hold Letter, Additional Information Letter for a 510(k))?
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 over each time and create an eCopy that meets the technical standards of Attachment 1 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.
What is the size limit for eCopies?
There is no size limit for the overall eCopy. However, an individual PDF must not be more than 50MB or it will fail the loading process. Make sure you look at the size of each PDF burned on your CD, DVD, or flash drive to determine if it exceeds the 50MB size.
Why and how should I use the eSubmitter-eCopies tool?
Use of the eSubmitter-eCopies tool is voluntary. However, it can help create an eCopy that is consistent with technical standards in the eCopy guidance. The tool will “package” (or save) the eCopy on your local drive in a folder with a unique identification (ID) number. Open up the folder with the unique ID and the content inside is your eCopy. Save that content to a CD, DVD, or flash drive. Note that if your submission includes any content that does not appear in the folder, it will fail the loading software and lead to an eCopy hold.
You cannot submit your eCopy to the FDA through the eSubmitter-eCopies tool. You must submit your eCopy with the accompanying paper copy of your company letter, including an eCopy statement and signature to the Document Control Center (DCC).
Why was my submission placed on eCopy hold?
The eCopy hold letter will contain a complete list of specific reasons why your eCopy failed the loading process. You can find steps to correct each failure in the eCopy guidance. For example, if the eCopy hold letter states that your PDF has an invalid naming convention, please refer to the section in the eCopy guidance on the PDF file naming convention.
What should I do if I receive an eCopy hold letter?
You should submit a replacement eCopy with a paper copy of your company letter, including an eCopy statement and signature to the Document Control Center (DCC). On the CD, DVD, or flash drive, please write “Replacement eCopy” and the full document number indicated on your eCopy hold letter.
In your replacement eCopy, please provide the complete content for that specific document (original, supplement, report, or amendment), not just the corrections. Do not supply just the corrected PDF. For example, if you submitted an eCopy for Supplement 1 to a 510(k) that includes 10 PDFs, and received an eCopy hold letter for Supplement 1 that identified an invalid naming convention for one of those PDFs, your replacement eCopy for Supplement 1 would include all 10 PDFs with the corrected naming convention for the invalid PDF.
Can I submit a response to an eCopy hold letter via email?
No. You must submit your response formally to DCC. We do not accept responses to eCopy hold letters via email or fax or through the FDA reviewer.
If the only error identified in the eCopy hold letter involves the company cover letter, do I have to resubmit the eCopy?
No. You only have to provide a paper copy of the corrected company cover letter (including an eCopy statement and a signature.
Please note that the company cover letter should not be confused with FORM FDA 3514 (CDRH Premarket Review Submission Cover Sheet). Your company cover letter is a document on your letterhead that includes the purpose of your submission, contact information (including phone number and email address), and signature.
Do I have to include the company cover letter on the replacement eCopy?
You do not need to add a PDF of your company cover letter to your replacement eCopy, but you do need to submit a paper copy of the company cover letter (including an eCopy statement and a signature) to the DCC with your replacement eCopy. DCC will date stamp and scan in the paper copy of your company cover letter that accompanies your replacement eCopy.
Why do I have to resubmit a company cover letter with every replacement eCopy?
DCC needs a paper copy of the company cover letter (including an eCopy statement and signature) so that they can process the replacement eCopy. DCC date-stamps the company cover letter with the receipt date of your replacement eCopy.
Where should I send my medical device submission package?
Send your medical device submission package to the Document Control Center (DCC) at the following address:
Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Your medical device submission package should include a paper copy of the application and your eCopy(ies) with a paper copy of your company cover letter (including an eCopy statement and signature).
Can I submit information to the reviewer and not go through the DCC?
No. New submissions and responses to review hold letters must be submitted to the DCC. Please do not submit this information to the FDA reviewer. However, if the submission is under review, the FDA reviewer can request and receive information via the Interactive Review process. (For more information about the Interactive Review process, please refer to the guidance document at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM341948.pdf). Interactive Review responses are handled via email (preferred), fax, or phone, and added to the review record by the reviewer. Please do not mail anything to FDA unless your files are too large to be emailed. As stated in the eCopy guidance, if you do mail Interactive Review responses, they will be processed by DCC and subject to eCopy processing.