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Instructional Checklist for the Manual Creation of eCopy compliant submissions for CDRH
Version 1 (3/2/15)
Please note that per federal regulation, submissions requiring an eCopy that are submitted without an eCopy as well as eCopy submissions that
do not meet the federal standards, will be placed on hold until a valid eCopy is submitted to FDA and verified to meet the standards. While the
submission is on hold, the review clock will not begin and the submission will not be reviewed.
Please find below a set of instructions using a checklist format for how to make submissions to CDRH which must comply with the eCopy
requirements.
NOTE: As an alternative to manually creating eCopy’s, the FDA has created a free eSubmitter-eCopies tool that is available on their website at
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm317334.htm. The use of this tool is optional but will guarantee that an eCopy will be created
in real-time that is consistent with the technical standards described in Attachment 1 of FDA’s guidance document: eCopy Program for Medical
Device Submissions . This tool guides you through the steps of adding the content and will add any required prefixes to volumes/folders and PDFs.
Questions about the eSubmitter-eCopies tool can be emailed to the FDA at [email protected].
eCopy Checklist
1.
Determine if your submission requires an eCopy
An eCopy is REQUIRED for the following:
All submissions related to an IDE (i.e. initial application, supplements, annual reports, etc.)
Pre-submission for a pre-IDE consultation
Pre-submission for a Nonsignificant Risk (NSR)/Significant Risk(SR) Device Determination Request
Pre-submission for to obtain feedback on the use of data collected from a study located outside of the United States (OUS) to
support clearance or approval
An eCopy is VOLUNTARY for the following:
Compassionate Use IDE Application if there is insufficient time to prepare the eCopy
Emergency Use IDE Application if there is insufficient time to prepare the eCopy
Device Master File Submissions
Yes
No
An eCopy is required for my submission
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2.
Determine if your eCopy will be an exact duplicate of your hardcopy submission
If your submission contains any of the following or comparable materials which are not practical or feasible to submit in a hardcopy then
that information can be included only in the eCopy
Raw data and statistical analysis programs
Data line listings
Videos
X-rays
Other
Yes
No
My eCopy will be an exact duplicate of my hardcopy submission
3.
Create the sponsor-investigator’s cover letter
Printed on the sponsor-investigator’s letterhead
Describes the reason for the submission (and submission tracking number if one has already been assigned)
Contains complete contact information for the sponsor-investigator
Sponsor-investigator’s full name
Sponsor-investigator’s address
Sponsor-investigator’s phone number
Sponsor-investigator’s fax number
Sponsor-investigator’s email address
Contains the “eCopy” statement
If the response to Item #2 above was “Yes” then the statement inserted in this letter reads “The eCopy is an exact duplicate of
the paper copy”
If the response to Item #2 above was “No ” then the statement inserted in this letter reads “The eCopy is an exact duplicate of
the paper copy except {specify all the differences}”
 Per item #10 below, everywhere a placeholder is included in the paper copy, that omitted information must be
identified and explained as a difference in the eCopy statement
Is signed by the sponsor (may be a wet (i.e., ink) signature or a valid digital signature)
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4.
Format all documents that are required for your submission and will be converted to a pdf format
 If your submission includes one of the file types that is listed under item #8 below, it can be submitted in its native, non-pdf
format and these formatting requirements do not apply
A single 12 point, black font is used throughout the document that corresponds to one of the following:
Times New Roman
Verdana
Arial
Tahoma
Helvetica
Hyperlinks are used to refer to other information/sections within the same pdf that are limited to the following styles of formatting:
Rectangles using thin lines
Blue text
Invisible rectangles for hypertext links in a table of contents
All embedded attachments are removed
5.
Convert all document(s) from Item #4 to a pdf format
pdf ‘s are created only by converting files from their native format using Adobe Acrobat Version 11 or below when possible
If Adobe Acrobat Versions greater than 11 are used the pdf must be saved as a reduced size pdf
pdf ‘s are NEVER created by :
Using Adobe plug-ins
Scanning
Bookmarks are used to reference main features of the document such as :
Main Table of contents
Section headings
Sub-section headings
Figure Titles
Table Titles
All embedded attachments and/or attributes are removed
All security settings are removed; no pdfs requiring passwords to open
Each PDF must be 50MB or smaller in size
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6.
Name your pdf
The naming convention for all PDF files is :
xxx_Descriptive Name
A non-repeating consecutive 3 digit number (xxx) followed by an underscore(_) followed by a Descriptive name
There are no spaces between the number and the underscore or the Descriptive Name and the underscore
The first pdf is named 001_ Descriptive Name
 The first pdf is named 001_Descriptive Name even if it’s the only pdf in the submission
All subsequent pdfs are named:002_Descriptive Name; 003_Descriptive Name, etc.
The Descriptive Name should be informative about the contents of the pdf and must comply with the following formatting
requirements:
Can contain up to 125 characters
Can include spaces, underscores and periods
Must not use any of the following special characters:
• tilde (~)
• asterisk (*);
• elongated dash (–);
• apostrophe (’);
• single quotation mark (‘);
• double quotation marks (“);
• colon (:);
• vertical bar (|);
• forward slash (/);
• backward slash (\);
• greater than sign (>);
• less than sign (<);
• question mark (?);
• various other symbols (e.g. pound sign (#); →, *, β, α,∞, ±, ™).
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7.
Create a non-volume based eCopy
NOTE: For very large or complex submissions, a volume-based eCopy may be recommended as per Attachment 1-Technical Standards for
eCopies in FDA’s guidance: eCopy Program for Medical Device Submissions. If preparing a volume –based eCopy, please contact the
Navigators at [email protected].
Select the eCopy medium (CD, DVD or flash drive) that will be used for your submission
 FDA has no preference
Delete any preloaded files before adding your eCopy to this medium
 Certain brands of media, particularly flash drives, come pre-loaded with files that may lead to your eCopy failing the loading
process.
Add all pdfs which are needed for your submission to the root level only
 The root level is the main level that is seen when the CD, DVD or flash drive medium is opened) (For graphic examples, please
refer to Figures 2-8 in FDA’s guidance: eCopy Program for Medical Device Submissions )
After adding your pdf(s) to the eCopy medium confirm that none of these files are larger than 50 MB
File size is determined only by the size that is displayed at the main level when you open the medium
 For a graphic example please see Figure 12 in in FDA’s guidance: eCopy Program for Medical Device Submissions
If any file is larger than 50 MB it must be:
Broken down into smaller files which also can’t be any larger than 50 MB
Renamed in a way that shows that they originated from a single file
 If the file named 001_Descriptive name has to be broken down into 2 files to meet the size limitations, then the 2 files
might be named 001_Descriptive name-Part 1 and 002_Same Descriptive name-Part 2
 For a graphic example please see Figure 13 in in FDA’s guidance: eCopy Program for Medical Device Submissions
These sibling files are reloaded at the root level of the eCopy medium and the individual sizes are confirmed as above
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8.
Adding non-PDF files to your eCopy
Non-pdf files are only added to a “STATISTICAL DATA” or “MISC FILES” folder
“STATISTICAL DATA” or “MISC FILES” folders are to be placed only at the root level of the eCopy
(For a graphic example please see Figure 14 in FDA’s guidance: eCopy Program for Medical Device Submissions )
If you add a STATISTICAL DATA folder to the eCopy then it only contains statistical information (including metadata and data line
listings)
Acceptable file formats for statistical information include but are not limited to:
 SAS
 XPORT
 XML
 SGML
 S-Plus
 R files
 ASCII
 Molfiles
 Excel
File Formats that include variable labels and dictionary information (such as SAS XPORT) are encouraged
If you add a “MISC FILES” folder to the eCopy, then it may contain any files (in any file format) that are not statistical in nature (e.g.,
videos, x-rays, machine readable software source code) AND cannot be submitted in pdf format
Microsoft Word versions of information that is already provided in the main body of the eCopy as a pdf is suggested if you
anticipate the reviewer may want access to an editable form of the document to provide their feedback
There are no naming conventions or restrictions that must be followed for naming files added to the MISC FILES folder
All non-pdf files are zipped into one or more zip files, that should not be larger than 50 MB, before they are added to the “STATISTICAL
DATA” or “MISC FILES” folder
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9.
Determine how many eCopies must be submitted together with a single paper copy for your submission type
Submission Type
IDEs
 Compassionate use IDEs
 Emergency use IDEs
 All other types of IDE
submissions
Pre-Submissions
Device Master Files
10.
eCopy
Required or
Voluntary
Required
Voluntary
Voluntary
Required
Total number of Copies
To be Submitted
Number
eCopies
3
3
3
3
Number
Paper
Copies
1
1
1
1
2
2
2
2
Number of cover letters
with eCopy Statement
(Item #3)
1
1
1
1
Required
Voluntary
2
2
1
1
1
1
1
1
Special Formatting Requirements for Paper Copies which do not contain all of the information submitted in the eCopy

This section is applicable only if you responded “No” to Item #2 above: My eCopy will not be an exact duplicate of my hardcopy
submission
A placeholder is included in the paper submission referring to the exact location in the eCopy where the information that couldn’t be
included can be found.
There must be a placeholder for every difference cited between the eCopy and paper copy as described in the eCopy statement in
the sponsor’s cover letter (see item # 3 above)
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11.
Formatting requirements for the Paper Copy submission
Each page is sequentially numbered
Where possible, each page should contain a header that identifies the submission to which it belongs
 An example would be :
[Left Hand Side]
[Right Hand Side]



[INSERT: Sponsor-Investigator Name]
[INSERT Device Name]


Type of Submission (i.e. Pre-submission, SR/NSR determination,
Initial IDE application, IDE annual report, etc.)
Submission date
IDE number (if known/applicable)
The left margin is at least a 1 1/2" wide
Documents are bound for submission in an ACCO-type binder (this link also contains ordering information from Office Depot) and
NEVER in any type of ring binder.
 ACCO type binders can be ordered online from any of the major office supply companies, but are almost never found in the
brick and mortar stores.
An adhesive label (i.e. Avery) is attached to the cover of the ACCO binder and is labeled with the following information:
Type of Submission (i.e. Pre-submission, SR/NSR determination, Initial IDE application, IDE annual report, etc.)
Submission date
IDE number (if known/applicable)
Device Name
Sponsor-Investigator Name
Volume # /Total number of Volumes submitted
 Only applicable in cases where the submission is too large to fit into a single binder (capacity reported to be 600
pages)
 If for example the submission was 1750 pages, a total of 3 binders are used which would be labeled as Volume #1 of 3;
Volume # 2 of 3 and Volume # 3 of 3.
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12.
Shipping the submission to the FDA
NOTE: For shipping submissions to FDA for IDEs regulated by CBER, please contact the Navigators at [email protected]
The mailing address for devices regulated by the Center for Devices and Radiological Health is:
Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Ship via a carrier such as FEDEX or UPS who will provide you with a receipt that shows when the submission was received by the
FDA
References used to compile this document:
1. eCopy Program for Medical Device Submissions, October 10, 2013
2. SOPP 8007: DCC Binding Procedures for Regulatory Documents Version #2, November 13, 2009
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