Contains Nonbinding Recommendations 
 
eCopy Program for Medical Device 
Submissions 
 
 
Guidance for Industry and Food  
and Drug Administration Staff 
 
Document issued April 27, 2020. 
 
 
This document supersedes the guidance of the same title dated 
December 16, 2019. 
 
 
 
 
For questions regarding this document, contact CDRHs eCopy Program Coordinators at 240-
402-3717 or cdrh-eCopyinfo@fda.hhs.gov  or CBERs Office of Communication,  Outreach and 
Development, at 1-800-835-4709  or 240-402-8010,  or by email at ocod@fda.hhs.gov. 
 
 
 
 
 
 
 
 
 
 
      U.S. Department of Health and Human Services 
  Food and Drug Administration 
  Center for Devices and Radiological Health 
Center for Biologics Evaluation and Research 
 
 
  Contains Nonbinding Recommendations 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration  to 
http://www.regulations.gov.   Submit written comments to the Division  of Dockets Management, 
Food and Drug Administration,  5630 Fishers Lane, Room 1061, (HFA-305), Rockville,  MD, 20852.  
Identify all comments with the docket number FDA-2018-N-0628. Comments may not be acted 
upon by the Agency until the document is next revised or updated.   
 
Additional Copies 
 
Additional  copies are available from the Internet.  You may also send an e-mail request to CDRH-
Guidance@fda.hhs.gov  to receive an electronic copy of the guidance.  Please include the document 
number 1797-R2 and complete title of the guidance in the request. 
 
Additional  copies of this guidance document are also available from the Center for Biologics 
Evaluation  and Research (CBER), Office of Communication,  Outreach, and Development (OCOD), 
10903 New Hampshire Ave., Bldg. 71, Room 3128, Silver Spring, MD 20993-0002,  or by calling 
1-800-835-4709  or 240-402-8010,  by emailing  ocod@fda.hhs.gov, or from the Internet at  
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances.   
Table of Contents 
I.  Introduction ........................................................................................................................... 1 
II.  What is an eCopy? ................................................................................................................. 3 
III. For what submission types is an eCopy required? .................................................................... 3 
IV. Are there other submission  types not subject to the eCopy legislation  for which eCopies may be 
submitted? ............................................................................................................................. 5 
V.  How many copies of a submission are needed?........................................................................ 6 
VI. What are the processing steps for an eCopy? ........................................................................... 7 
a.  What are the technical standards for an eCopy? .............................................................. 7 
b.  What are the recommended methods for creating an eCopy?........................................... 7 
A.  Bookmarks and Hyperlinks within PDFs ........................................................................ 7 
B.  Creating a PDF File from the Source Document (Preferred) .......................................... 8 
C.  Creating a PDF File from a Scanned Document............................................................. 9 
c.  Are there special considerations  when developing  an eCopy for an original  submission 
versus a response to a review hold notification?.............................................................. 9 
d.  Are there any issues to consider when choosing the eCopy media?.................................10 
e.  What if there is another submitting party involved? .......................................................10 
f.  What if this is a Third Party 510(k)? .............................................................................10 
g.  What if this is a bundled submission?............................................................................11 
h.  How do you create an eCopy that meets the technical standards? ...................................11 
i.  How do you know if an eCopy meets the technical standards before you send it to FDA?
  12 
j.  How do you submit an eCopy to FDA? .........................................................................13 
k.  How does FDA process an eCopy? ...............................................................................13 
l.  What do you provide to FDA in response to an eCopy hold?..........................................14 
m.  How does FDA process a replacement eCopy? ..............................................................14 
n.  What timeframes need to be considered? .......................................................................15 
o.  When does review of a submission begin?.....................................................................15 
p.  If you submitted an eCopy for a submission  type that did not require an eCopy and you 
received an eCopy hold letter, what are your options?....................................................15 
VII.  What if your device is regulated by CBER?...................................................................15 
Attachment 1  Technical Standards for eCopies..........................................................................17 
A.  Company Cover Letter Requirements............................................................................18 
B.  Volume or Non-Volume Structure Requirements...........................................................19 
C.  PDF File Requirements ................................................................................................23 
D.  Requirements for How to Add Non-PDF Files via STATISTICAL DATA and MISC 
FILES Folders ............................................................................................................26 
  29   
eCopy Program for Medical Device 
Submissions  
 
Guidance for Industry and Food and 
Drug Administration Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.  
 
I.  Introduction 
 
The purpose of this guidance is to explain the eCopy Program for medical device submissions.   
Section 745A(b) of the FD&C Act, added by section 1136 of the Food and Drug Administration 
Safety and Innovation  Act (FDASIA) (Pub. L. 112-144),  requires the submission  of electronic 
copies (eCopies) with the issuance of this final guidance.  This guidance describes how the Food 
and Drug Administration  (FDA) is implementing  the eCopy Program under section 745A(b) of 
the FD&C Act.  The inclusion  of an eCopy is expected to improve the efficiency of the review 
process by allowing  for the immediate availability  of an electronic version for review rather than 
relying solely on the paper version. 
 
This guidance provides, among other things, the standards for a valid eCopy under section 
745A(b)(2)(A) of the FD&C Act.  In accordance with section 745A(b), submission  types 
identified  in this final guidance must include an eCopy in accordance with the standards 
provided by this guidance for the submission  to be processed and accepted for review by FDA, 
unless they have been identified  as being exempted or waived.  Submissions  submitted without 
an eCopy and eCopy submissions  that do not meet the standards provided in this guidance will 
be placed on hold until a valid eCopy is submitted to FDA and verified to meet the standards, 
unless a waiver or exemption  has been granted.  While the submission  is on hold, the review 
clock will not begin and the submission  will not be reviewed. 
 
FDA has also issued a final rule entitled Medical Device Submissions:   Amending Premarket 
Regulations that Require Multiple  Copies and Specify Paper Copies to Be Required in Electronic 
Format1 to amend certain regulations (21 CFR 807.90, 807.95, 812.19, 812.20, 814.20, 814.39, 
814.104) regarding the number of required copies and to remove the requirement for paper 
copies.  These amendments are intended to improve the efficiency of the eCopy program, to 
                                                             
1 84 FR 68334 
 
1   
significantly  reduce the burden on applicants, and to support our future transition to submissions 
solely in electronic format.2  Accordingly,  we will  no longer require paper copy(ies) of a 
submission  to accompany an eCopy.  However, a paper copy of the signed cover letter and one 
valid eCopy of the submission  must still be submitted. 
 
In section 745A(b), Congress granted explicit  statutory authorization  to FDA to implement the 
statutory eCopy requirement by providing  standards, criteria for waivers, and exemptions in 
guidance.  Accordingly,  to the extent that this document provides such requirements under 
section 745A(b) of the FD&C Act (i.e., standards, criteria for waivers, and exemptions), 
indicated by the use of the words must or required, this document is not subject to the usual 
restrictions in FDAs good guidance practice (GGP) regulations,  such as the requirement that 
guidances not establish legally enforceable responsibilities.  See 21 CFR 10.115(d). 
 
However, this document also provides guidance on FDAs interpretation  of the statutory eCopy 
requirement and the Agencys current thinking  on the best means for implementing  other aspects 
of the eCopy program.  Therefore, to the extent that this document includes provisions  that are 
not standards, criteria for waivers, or exemptions under section 745A(b)(2), this document 
does not create or confer any rights for or on any person and does not operate to bind FDA or the 
public,  but does represent the Agencys current thinking  on this topic.  The use of the word 
should in such parts of this guidance means that something is suggested or recommended, but not 
required.  You can use an alternative approach if the approach satisfies the requirements of the 
applicable statutes and regulations.  If you want to discuss an alternative approach, contact the 
FDA staff listed on the title page of this guidance. 
 
To comply with the GGP regulations  and ensure that regulated entities and the public  understand 
that guidance documents are nonbinding,  FDA guidances ordinarily  contain standard language 
explaining  that guidances should be viewed only as recommendations  unless specific regulatory 
or statutory requirements are cited.  FDA is not including  this standard language in this guidance 
because it is not an accurate description of all of the effects of this guidance.  This guidance 
contains both binding  and nonbinding  provisions.   Insofar as this guidance provides standards, 
criteria for waivers, and exemptions  pursuant to section 745A(b) of the FD&C Act, it will 
have binding  effect.   
 
The eCopy program is not intended to impact (reduce or increase) the type or amount of data the 
applicant includes in a submission  to support clearance or approval.  For the purposes of this 
guidance, applicant includes submitter,  sponsor, or holder.  Please refer to other FDA 
device or program-specific guidance documents from CDRH3 and CBER4  for the appropriate 
contents for submissions.   
 
For additional  eCopy Program resources, please refer to FDAs webpage entitled,  eCopy 
Program for Medical Device Submissions.5   
                                                             
2 See 745(A)(b)(3) of the FD&C Act 
3 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-
medical-devices-and-radiation-emitting-products 
4 https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances 
5 https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-program-medical-device-
submissions 
2   
 
II.  What is an 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.  The cover letter signature may be a wet 
(i.e., ink) signature or a valid digital  signature.  Please note that other forms submitted within 
premarket submissions (e.g., Truthful and Accurate Statement for 510(k)s) can also be signed 
with either a wet signature or a valid digital  signature.  Please also note that an eCopy 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.  The non-human readable documents contain richer information 
about the submission,  such as structured data, how the submission  is organized, modifications  in 
comparison to a previous version, etc. An eCopy can be considered a static representation of the 
submission,  while an eSubmission can be considered a dynamic representation of the 
submission.6   
 
   
III.  For what submission types is an eCopy required? 
In accordance with Section 745A(b) of the FD&C Act, as added by section 1136 of FDASIA, 
and the CDRH guidance on Q-submissions7,  an eCopy is required for the following  submission 
types: 
  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; 
  This includes all PMA submission  types, including,  but not limited  to, original 
o
PMAs, panel-track supplements,  180-day supplements,  manufacturing site change 
supplements, 30-Day Notices, 135-Day Supplements,  and post-approval study 
supplements and reports, as well as amendments involving  changes in the 
correspondent or ownership and requests for extensions. 
  Modular PMAs; 
  Product development  protocols (PDPs);  
  Investigational  device exemption (IDE) submissions   
                                                             
6 For information on eSubmissions produced by the eSubmitter application, refer to FDA eSubmitter page 
(https://www.fda.gov/industry/fda-esubmitter) and Regulatory Submissions in Electronic Format for Biologic 
Products (https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/regulatory-
submissions-electronic-format-biologic-products). 
7 Requests for Feedback on Medical Device Submissions: The Q-Submission Program 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program ). 
 
3   
  This includes all IDE submissions  including  Original  IDEs, IDE reports, IDE 
o
supplements and amendments to each of those [see Exemptions below].8 
  Humanitarian device exemptions (HDEs) submissions 
  This includes all HDE submission  types, including,  but not limited  to, original 
o
HDEs, 180-day supplements,  manufacturing site change supplements, 30-Day 
Notices, 135-Day Supplements,  and post-approval study supplements and reports, 
as well as amendments involving  changes in the correspondent or ownership and 
requests for extensions. 
  Emergency Use Authorizations  (EUAs)9 [see Exemptions below]; 
  Certain investigational  new drug applications  (INDs); 
  Applicable  only to those INDs required prior to the submission  of a BLA for 
o
devices that are regulated by CBER as biological  products under Section 351 of 
the Public Health Service (PHS) Act. Such INDs are generally those intended for 
use in screening donated blood for transfusion transmissible  diseases. 
  Certain biologics  license applications  (BLAs);  
  Applicable  only to those devices that are regulated by CBER as biological 
o
products under Section 351 of the Public Health Service (PHS) Act whether or 
not they also require submission  of an IND prior to submission  of a BLA. Such 
devices are generally those intended for use in screening donated blood for 
transfusion transmissible  diseases and compatibility testing. This includes 
Original  Applications,  Efficacy Supplements,  Prior Approval Supplements (PAS), 
Changes Being Effected in 30 Days (CBE-30), Changes Being Effected (CBE), 
Labeling Supplements,  and Annual Reports; and 
  Q-submissions.2   
 
eCopies for all subsequent submissions  to an original  submission,  including  amendments 
(amendments include add-to-files and appeals), supplements,  and reports (reports include 
annual/periodic  and post-approval  reports) to the submission  types identified  above, as well as 
amendments to supplements and reports, are also required.  Please note, Section 745A(b) of the 
FD&C Act does not apply to Medical Device Reports submitted under 21 CFR Part 803.   
 
Whether it is a single-page submission  (i.e., the company cover letter is the only content) or a 
multi-volume  submission,  the eCopy requirements apply. Although  there is no maximum  total 
submission size restriction,  it is recommended that the total package submission  not exceed 1 GB 
to avoid possible delays in the submission  process.   
 
Responses to deficiency letters are required to be formally  submitted to CDRHs or CBERs 
Document Control Center10 (DCC) to be logged in as an amendment or a supplement and, thus, 
are subject to the eCopy requirements. 
                                                             
8 For a description of IDE submission types, please see Section 9 of FDA Guidance FDA Decisions for 
Investigational Device Exemption Clinical Investigations, at https://www.fda.gov/regulatory-information/search-
fda-guidance-documents/fda-decisions-investigational-device-exemption-clinical-investigations. 
9 Refer to the guidance entitled, Emergency Use Authorization of Medical Products 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-
medical-products-and-related-authorities), for more information on EUAs. 
10 Refer to 21 CFR 807.90 for the DCC addresses for CDRH and CBER. 
4   
 
Please note that eCopy requirements do not apply to information obtained during the 
Interactive Review process (via email, phone, and/or fax) once a submission is under 
review, if that information is not mailed to FDA.  However, should an applicant choose to 
mail a response to an Interactive Review request (which should only occur if the size of the 
response makes communication  by email or fax infeasible),  it will be logged in as an amendment 
and be subject to the eCopy requirements. 
 
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. 
 
Although these submission  types do not require eCopies as per this exemption,  FDA encourages 
you to submit eCopies of these submissions,  when feasible, in order to facilitate the review 
process. If submission  of an eCopy is not feasible, but there is pertinent electronic information, 
such as imaging  data, to supplement the information  in the paper copy, please contact the lead 
reviewer to submit this information  via Interactive Review.  If you choose to submit an eCopy, it 
must meet the technical standards outlined  in Attachment 1. 
 
Waivers 
FDA believes that, given the widespread availability  of software to enable the creation of an 
acceptable eCopy at little to no cost, all applicants should have the ability  to provide an eCopy. 
Therefore, FDA is not granting waivers for providing  an eCopy.    
 
IV.  Are there other submission types not subject to the eCopy 
legislation for which eCopies may be submitted? 
Although an eCopy is not required under Section 745A(b) of the FD&C Act, FDA also accepts 
and encourages you to submit eCopies for: 
  Master Access Files (MAFs); 
  513(g) Requests for Information (513(g)s); and 
  CLIA Waiver (CW) and CLIA Request (CR).   
 
eCopies for these three submission types are voluntary;  however, if you choose to submit an 
eCopy, it must meet the technical standards outlined  in Attachment 1.   
                                                             
11 Please refer to CDRHs device advice page entitled Expanded Access for Medical Devices (see 
https://www.fda.gov/medical-devices/device-advice-investigational-device-exemption-ide/expanded-access-
medical-devices).   
5   
 
V.  How many copies of a submission are needed? 
The eCopy Program does not change the overall number of copies to submit to FDA.  Table 1 
below provides the number of copies associated with each submission  type for which an eCopy 
is either required or voluntary.  The eCopy must be accompanied by a single paper copy of your 
signed cover letter.  In addition,  FDA review staff should not request a paper copy or an 
additional  eCopy from the applicant. 
 
Table 1  Number of Copies for Submission 
Submission Type  Required or  Total Number and 
Voluntary  Format of Copies 
eCopy 
510(k)s, including  Third Party 510(k)s 12  Required  1 eCopy  
De Novos 
PMAs, including  Transitional  PMAs 
  Original  PMAs 13 
  Panel-Track Supplements 17 
  All other PMA supplement types (e.g., 
180-Day Supplements,  Real-Time 
Supplements,  30-Day Notices, 135-Day 
Supplements)  14 
  PMA reports (annual reports and post-
approval study reports) 
  Modular PMAs 
PDPs 
HDEs 15 
Q-Submissions 
INDs 16 
BLAs and associated amendments  
  Original  BLAs 
  Efficacy Supplements 
  Changes Being Effected in 30 Days 
(CBE-30) 
  Changes Being Effected (CBE) 
  Labeling Supplements 
  Annual Reports 
IDEs 17     
                                                             
12 See 21 CFR 807.90(a)(3)(c). 
13 See 21 CFR 814.20(b)(2). 
14 See 21 CFR 814.39(c). 
15 See 21 CFR 814.104(b)(4). 
16 See 21 CFR 312.23(d). 
17 See 21 CFR 812.20(a)(3). 
6   
Submission Type  Required or  Total Number and 
Voluntary  Format of Copies 
eCopy 
  Compassionate use submissions,  Voluntary  1 eCopy or  
emergency use reports, and adverse    1 complete paper copy 
event reports  
  All other types of IDE submissions  Required  1 eCopy  
CLIA submissions  (CRs and CWs)  Voluntary  1 eCopy or  
513(g)s  1 complete paper copy 
MAFs 
EUAs  Voluntary  1 eCopy or  
1 complete paper copy or 
1 copy via email18  
 
For compassionate use IDE submissions,  emergency use IDE reports, adverse event IDE reports, 
EUAs, MAFs, 513(g)s, and CLIA submissions  (CRs and CWs), you may choose to submit only 
paper copies because an eCopy is voluntary.  However, if you choose to submit an eCopy for one 
of these submission  types, it must meet the technical standards outlined in Attachment 1.   
 
VI.  What are the processing steps for an eCopy? 
Below are the processing steps for the submission  and acceptance of an eCopy. 
 
a.  What are the technical standards for an eCopy? 
The technical standards for an eCopy are detailed in Attachment 1.  An eCopy that does not 
meet the technical standards in Attachment 1 will not be accepted. If an eCopy is not 
accepted, the file will be placed on eCopy hold until a valid replacement copy is provided. 
 
b.  What are the recommended methods for creating an eCopy? 
A.  Bookmarks and Hyperlinks within PDFs 
Bookmarks and hyperlinks  within a single PDF file should be used to assist the reviewers in 
navigating  through the content of the submission.   However, while these are not required 
elements for an eCopy, bookmarks and hyperlinks  are essential for the efficient navigation 
through documents.  If you use either bookmarks or hyperlinks,  consider the following: 
 
Bookmarks and links references can be created for the heading of a section, subsection, or 
title of figures and tables within a single PDF file.  In general, including  a meaningful 
bookmark to the main table of contents for a submission  or item is helpful,  and will aid the 
reviewer in locating information  and navigating  the submission.   
 
                                                             
18 For the email address to send EUAs see section D.3. of the FDA guidance Emergency Use Authorization of 
Medical Products and Related Authorities (https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/emergency-use-authorization-medical-products-and-related-authorities). 
7   
Hyperlinks are used to improve navigation  through individual  PDF documents and are 
encouraged.  Hyperlinks  can be designated by rectangles using thin lines or by blue text or 
you can use invisible  rectangles for hypertext links in a table of contents to avoid obscuring 
text (note: use of blue text for hyperlinks  is the most widely recognized style).  Hyperlinks 
throughout  the body of the document to support annotations, related sections, references, 
appendices, tables, or figures that are not located on the same page are helpful and improve 
navigation  efficiency.   
 
Bookmarks and links are usually most easily created in a word processor by using titles, 
headers, or styles which can be translated to bookmarks when the file is converted to PDF.  
Alternatively,  bookmarks can be created in the final PDF document either by selecting text 
and creating a new bookmark to that location with that text as the name, or making a new 
bookmark and naming it manually. 
 
While it is common to use bookmarks and hyperlinks  within a single PDF file, it is also 
possible to create bookmarks and hyperlinks  to other PDF files in your submission.  We 
recommend using bookmarks and hyperlinks  to other PDF files when use of those features 
will assist reviewers navigating  through your submission.   If you choose to use these features 
to navigate between different PDF files, then please remember to 1) use relative rather than 
absolute file paths, 2) use file names that are consistent with the eCopy requirements, and 3) 
use folder names that are consistent with the eCopy requirements.  Please note the 
requirement to use numeric prefixes in file names, which will allow your files to appear in a 
meaningful  order (rather than alphabetical order based on the first letter of each file name).  
Changing the file or folder names after you insert the links will break the links.  If you use 
the eSubmitter tool to modify your file or folder names in order to fulfill  the eCopy 
requirements, then any links between PDF files may no longer function. 
 
B.  Creating a PDF File from the Source Document (Preferred) 
Creating a PDF file from the source document is the preferred method of PDF creation, 
because this will allow for the automatic creation of searchable text in the PDF. If you have 
created hyperlinks  and bookmarks in your document, we recommend that you test the links 
after you have created the PDF file to ensure that the links function correctly. When creating 
a PDF from the source document (e.g., Microsoft Word document), please consider the 
following: 
 
1.  Adobe Plug-Ins 
If you use Adobe plug-ins  within PDF files and/or to capture or display data, there is a risk 
that information  may not display correctly because reviewers may not have access to certain 
plug-ins  to review content being displayed by a plug-in. 
 
2.  Fonts 
One of the following  fonts should be used in your source document:  Times New Roman; 
Verdana; Arial; Tahoma; or Helvetica.  You should avoid using customized fonts and 
multiple  fonts within  the same document. We recommend the same font is used throughout 
the submission. 
8   
 
We recommend the use of a black font color.  Blue font may be used for hypertext links.  If a 
font color other than black is used, avoid light colors that do not print well on grayscale 
printers.  It is advised that you test the color reproduction prior to submission  by printing 
sample pages from the document using a grayscale printer.   
We recommend a font size of 12; however, we will accept smaller fonts. 
 
C.  Creating a PDF File from a Scanned Document 
The applicant should create all PDF files directly from the source documents whenever 
feasible rather than creating them by scanning.  PDF documents produced by scanning 
paper documents are far inferior to those produced directly from the source document, 
such as a Microsoft Word document, and, thus, should be avoided if at all possible.  
Paper documents that include a watermark, such as DRAFT or COPY, are not suitable for 
scanning as the watermark makes the scanned document difficult  or impossible  to read.  
Scanned documents, particularly  tables and graphs, are more difficult  to read and do not 
allow the reviewers to copy and paste text for editing. 
 
For any scanned document, we recommend that you perform optical character recognition 
(OCR) so that the text is searchable.  If the text in your document is not searchable, the FDA 
will use the OCR technology  in the eCopy to make it searchable for reviewers.  Check to see 
that the content has been correctly converted by: (1) highlighting  an area of text and (2) 
searching for a word or phrase.  If the word or phrase is not returned in the search, then the 
OCR did not recognize the text.  FDA recognizes that use of OCR may not be feasible in 
some cases for documents with figures and images.  
 
Scanned documents, particularly  those with images, photographs, and video recordings tend 
to be large in file size.  Large file sizes may encounter more issues throughout the submission 
process thus causing delays.  Therefore, it is recommended that the total submission  package 
not exceed 1 GB. 
 
Please note that FDA recognizes there may be cases in which it is appropriate to have 
scanned documents added to an eCopy.  For example, if you do not digitally  sign the Truthful 
& Accuracy Statement for a 510(k), then a scanned PDF copy of that signed document would 
be added to the eCopy.   
 
FDA recommends that you follow these methods to create an eCopy.  However, while the 
methods described in this section are not requirements for eCopy, your eCopy must meet the 
technical standards in Attachment 1. 
 
c.  Are there special considerations when developing an eCopy for an original 
submission versus a response to a review hold notification? 
There are no special considerations because the eCopy program does not dictate the content 
of a document (original,  supplement, amendment, or report).  Each eCopy is its own entity, 
and the same technical standards in Attachment 1 apply to each eCopy.  This means that 
volume (if applicable) and PDF numbering start over with each new eCopy rather than 
9   
continuing  from a previously-submitted  eCopy.  Do not provide previously  submitted 
information  in a cumulative  fashion.  Only include content pertinent to the current 
submission  (e.g., an eCopy for a response to a 510(k) hold notification  only includes the 
response content, not the original  510(k) content plus the response content).  FDA 
recommends that you first determine what the content is, and then provide an eCopy that 
matches both in content and flow and meets the technical standards in Attachment 1.  
 
d.  Are there any issues to consider when choosing the eCopy media? 
It is up to each applicant whether to burn your eCopy onto a CD, DVD, or flash drive.  
However, please be aware that certain brands of media, particularly  flash drives, come pre-
loaded with files that may lead to your eCopy failing  the loading  process.  You should check 
the media for pre-loaded files and delete them before you burn your eCopy to the media. 
 
NOTE:  Should your submission  exceed the size of a standard CD, FDA recommends that 
you use a DVD or flash drive, which has greater storage space, rather than split up your 
eCopy across multiple  CDs. 
 
e.  What if there is another submitting party involved? 
In the case that another party (e.g., law firm, consultant) submits a submission  on behalf of 
an applicant, the eCopy must still meet the technical standards in Attachment 1 in order to be 
successfully processed by FDA.  The eCopy requirements are the same regardless of who is 
submitting  the eCopy.  While the applicant may or may not include their own company cover 
letter as part of the eCopy, our technical standards require that the submitting  party include a 
company cover letter.  
 
f.  What if this is a Third Party 510(k)? 
There are two distinct parties involved in the generation of a Third Party 510(k):  (1) the 
Accredited Person and (2) the applicant.  Each party is subject to the eCopy requirements.  
Accordingly,  each party (i.e., the Accredited Person and the applicant) must provide their 
own: 
  eCopy (on a single CD, DVD, or flash drive) that meets the standards in Attachment 
1; and 
  company cover letter with a signature as described in Section A of Attachment 1. 
 
Therefore, there will be two separate eCopies provided for a given Third Party 510(k).  
Given this, it is essential that each eCopy be clearly marked as belonging  to the Accredited 
Person or the applicant. 
 
FDA recognizes that an applicant may interact with the Accredited Person multiple  times 
prior to the Third Party 510(k) being submitted to FDA.  Regardless of the number of 
interactions prior to the Third Party 510(k) being submitted to FDA, the applicants eCopy 
must be on a single CD, DVD, or flash drive in order to be loaded by our software.  This 
could be accomplished by, for example, organizing  each round of interaction as different 
volumes in the eCopy (e.g., VOL_001_Original  Review, VOL_002_Round 2 Review).  The 
10   
Accredited Person must also provide their eCopy on a single CD, DVD, or flash drive for the 
same reason. 
 
Although the Accredited Person is FDAs point-of-contact and is the party that will be sent 
the eCopy hold notification  if there are any issues with either eCopy, each party is 
responsible for meeting the eCopy requirements.   
 
g.  What if this is a bundled submission? 
For bundled submissions,  there should be only one version of the company cover letter with a 
signature and only one eCopy that apply to all submissions  in the bundle.  There should not 
be different company cover letters or eCopies associated with each submission  in the bundle.  
The company cover letter should include a list or table of all submissions  that are part of the 
bundle.  The list or table should specify the submission  number, trade name, and, as 
applicable,  the model number, of each device impacted by the change.   
 
h.  How do you create an eCopy that meets the technical standards? 
There is a free eSubmitter-eCopies  tool available on FDAs website19, which we encourage 
applicants to use regardless of the Center to which you will be sending your submission.   Use 
of this tool is optional;  however, one of the benefits of the tool is that it creates an eCopy in 
real-time that is consistent with the technical standards described in Attachment 1.  The tool 
guides you through the steps of adding the content and will add any required prefixes to 
volumes/folders  and PDFs.   
 
As an additional  resource, there is a quick reference guide20 specific to the eSubmitter-
eCopies tool.  It is important that you use only this reference guide when using the 
eSubmitter-eCopies  tool and not the generic eSubmitter guides that are available. 
Tip to Applicants: If you add any files to your eCopy after using the eSubmitter-eCopies tool, you may 
create hidden temporary files or other errors that will cause the eCopy to fail the loading process.  If a 
document is open while you are adding it to the submission package and you have modified the 
document without saving it, then both the document and the hidden cache file of the document will be 
added to the submission package resulting in a failure when it reaches the FDA for processing.  To 
avoid this from occurring, you must save and close all documents prior to adding the document to the 
submission package. Use the eCopy Validation Module described in Section VI.i below, in order to 
verify the format of the eCopy.  
 
Please note that the eSubmitter-eCopies  tool does not transmit the eCopy through the FDA 
Gateway.  Instead, as shown in Figure 1, the eSubmitter-eCopies  tool provides the formatted 
eCopy content for you to download onto your local computer drive and then burn onto a CD, 
DVD, or flash drive.  The eCopy content is saved in a folder with a long alpha-numeric 
name.  You need to open up the folder with the long alpha-numeric name that was saved on 
your local computer drive and burn those contents onto your CD, DVD, or flash drive.  Do 
not add any of the files that the eSubmitter-eCopies  tool saves on your local computer drive 
                                                             
19 https://www.fda.gov/industry/fda-esubmitter/esubmitter-ecopies-tool 
20 https://www.fda.gov/media/84416/download 
11   
outside of that folder with the long alpha-numeric name, as those additional  files created by 
the eSubmitter-eCopies  tool are for your records only. 
 
 
 
 
 
Figure 1:  Snapshot of final packaging screen from eSubmitter-eCopies  tool  
 
 
Should you have any technical questions regarding the eSubmitter-eCopies tool, please 
contact cdrhesub@cdrh.fda.gov prior to submission  of the eCopy to FDA. 
 
 
i.  How do you know if an eCopy meets the technical standards before you 
send it to FDA? 
 
In order to determine if an eCopy meets the technical standards described in Attachment 1 
before sending it to FDA, we recommend that applicants verify an eCopy using the free 
eCopy Validation  Module that is now on FDAs website21, which we encourage applicants to 
use regardless of the Center to which you will  be sending your submission.   This voluntary 
tool will verify the format of an eCopy and provide information  on the error(s) contained in 
an eCopy.   
 
Figure 2 below shows the initial  screen of this tool.  You first identify  the location of the 
existing eCopy (e.g., CD, DVD, or flash drive) by clicking  Choose Folder.  Once you have 
selected the location of your eCopy, you click Run Analysis.  This tool runs through all of 
the technical standards described in Attachment 1 and either confirms that the eCopy meets 
Tip to Applicants: It is recommended that you use the eCopy Validation Module to check the final 
eCopy on the CD, DVD, or flash drive before submitting it to FDA in order to identify any errors or 
hidden files that may cause an eCopy to fail the eCopy Loader used by FDA.   
                                                             
21 https://www.fda.gov/industry/fda-esubmitter/esubmitter-ecopies-tool 
12   
the technical requirements or provides the reasons that it does not meet the technical 
requirements. If you do encounter an error, repackage the submission  and use the validator 
tool to verify the format again, before sending to FDA. 
 
 
 
 
Figure 2: Snapshot of initial  screen of eCopies Validator tool 
 
 
j.  How do you submit an eCopy to FDA? 
Attach a paper copy of your signed company cover letter to your eCopy CD, DVD, or flash 
drive, and send that package to CDRHs or CBERs Document Control Center (DCC).   
 
For Third Party 510(k)s, refer to Section VI.f. for the specifics of the eCopy and company 
cover letter associated with each of the two parties involved.   
 
k.  How does 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.22 
 
If an eCopy passes the loading process, the company cover letter and eCopy contents will  be 
loaded into the appropriate Centers official submission  repository. 
 
If an eCopy fails the loading  process, we will notify you in writing (e.g., by letter, email, 
and/or fax) that your submission  is on eCopy hold.  The eCopy hold notification  will describe 
the reasons for the eCopy failure and the logistics  for submitting  a replacement eCopy.  It is 
important that you follow these directions to avoid delays in processing the replacement 
                                                             
22 At CDRH, it is managed by the DCC staff.  At CBER, it is managed jointly by the DCC staff and the Regulatory 
Project Manager (RPM). 
13   
eCopy.  The submission will be placed and remain on eCopy hold until a valid 
replacement eCopy is submitted to FDA and verified to meet the technical standards of 
Attachment 1.23   
 
l.  What do you provide to FDA in response to an eCopy hold? 
As stated above, you will receive a notification  that states the specific reason(s) why your 
eCopy failed the loading  process.  In response to the eCopy hold notification,  you must 
provide:    
  a company cover letter with a signature (preferably with a revised date); and  
  a replacement eCopy (CD, DVD, or flash drive) that meets the technical standards of 
Attachment 1.  Be sure to label the media with the full submission  number and 
identify it as a replacement eCopy. 
 
Be sure that you provide a complete eCopy for the submission  at hand and not just the 
corrected files or folders.  For eCopies submitted to CBER only, in some cases only those 
files that could not be uploaded need to be resubmitted.  If you have been advised by the 
CBER RPM that a submission  tracking number has been assigned to your submission,  the 
new eCopy and its signed company cover letter should clearly identify the assigned 
submission  tracking number and state that the eCopy is an amendment to that submission. 
 
The company cover letter with a signature is required regardless of whether or not the eCopy 
failure was related to the company cover letter, because the DCC needs to be able to date 
stamp the company cover letter to record the receipt date of the replacement eCopy.   
 
Please note that if the only reason your eCopy failed is because of a lack of a signature on 
your company cover letter, then all you need to provide is a signed paper copy of your 
revised company cover letter in response to the eCopy hold notification.    
 
m. How does FDA process a replacement eCopy? 
When FDA receives a replacement eCopy, it is processed in the same manner as the initial 
eCopy.  More specifically,  a determination  is made as to whether or not the replacement 
eCopy passes the loading  process.  If it does not, then the submission  will be placed on 
eCopy hold again, and an eCopy hold notification  will be issued to you. You should submit a 
replacement eCopy with a signed paper copy of your company cover letter to the 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.  Please do not supply 
                                                             
23 Do not confuse an eCopy hold with a User Fee hold; a submission may be placed on User Fee hold for failure to 
pay the User Fee even if a valid eCopy is submitted.  In addition, do not confuse an eCopy hold with FDA 
decisions such as Refuse to Accept or Refuse to File.  An eCopy hold takes place before a submission is subject to 
any review process.  Once under review, if applicable for that submission type, acceptance and/or filing reviews will 
be performed.  See also Section VI.m of this guidance. 
14   
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 
should include all 10 PDFs with the corrected naming convention for the invalid  PDF. 
 
n.  What timeframes need to be considered?  
If you are submitting  a new submission  and receive an eCopy hold notification,  you should 
respond to that eCopy hold notification  within 180 days.  If FDA does not receive a 
replacement eCopy 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 days. 
 
o.  When does review of a submission begin? 
Review of a submission  will  begin only after a valid eCopy has been received and, if 
applicable,  the user fee has been paid.  As applicable  for the submission  type, acceptance or 
acceptance and filing  reviews will then be conducted.  Otherwise, the substantive review of 
the submission  will begin.24   
 
p.  If you submitted an eCopy for a submission type that did not require an 
eCopy and you received an eCopy hold letter, what are your options? 
If you submitted an eCopy for a compassionate use IDE submission,  emergency use IDE 
submission,  IDE adverse event report, EUA, MAF, 513(g), or CLIA submissions  (CRs and 
CWs), and it did not meet the technical standards in Attachment 1, your submission  will be 
placed on eCopy hold.  However, unlike the other submission  types that require a valid 
eCopy, you have the option of responding  to that eCopy hold notification  with an additional 
paper copy in lieu of a replacement eCopy. 
 
VII.  What if your device is regulated by CBER?  
CBER will accept an eCopy that includes all elements, including  the cover letter, and meets the 
standards in Attachment 1 through the FDA Electronic Submissions  Gateway (refer to 
Electronic Submissions  Gateway25) or on physical media through CBERs Document Control 
Center.  With the implementation  of the statutory requirement, all medical device submission 
                                                             
24 For more information, please see the guidances FDA and Industry Actions on Premarket Notification (510(k)) 
Submissions: Effect on FDA Review Clock and Goals (https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clock-
and-goals) and FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review 
Clock and Goals (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-
actions-premarket-approval-applications-pmas-effect-fda-review-clock-and-goals). 
25 https://www.fda.gov/industry/electronic-submissions-gateway  
15   
types listed in Section IV, as well as all subsequent submissions  to an original  submission, 
including  amendments, supplements,  and reports (reports include annual/periodic  and post-
approval reports) must be in the form of an eCopy regardless of the Center in FDA in which the 
submission  will be reviewed.   
 
You can submit questions pertaining  to the preparation of submissions  in electronic format for 
submission  to CBER at ESUBPREP@fda.hhs.gov. 
 
You may also contact CBER at CBER.CDISC@fda.hhs.gov to discuss the potential for 
submission  of data in CDISC format.26 
 
 
  
                                                             
26 https://www.fda.gov/industry/study-data-standards-resources/study-data-submission-cder-and-cber  
16   
Attachment 1  Technical Standards for eCopies 
Below are the standards that are written into the FDA eCopy software coding.  If an eCopy does 
not meet all of the required standards identified  in Sections A through D below, then the eCopy 
will not pass FDAs eCopy loading process.   
 
The following  section is a simple summary of the process for creating an eCopy.  It is critical 
that you read and understand all of the technical standards addressed in Attachment 1. 
 
The basic steps for developing an eCopy are as follows: 
 
1.  Determine the content of your document (original,  supplement, amendment, or report).  
This is not dictated by the eCopy program. 
 
2.  Create your company cover letter following  the specific requirements in Section A.  
Make sure your company cover letter includes a signature. 
 
3.  Based on the content, determine whether you want to have a volume-based or non-
volume-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.  See 
Section B below.   
 
If you chose a volume-based submission,  then add your volumes to the eCopy following 
the naming convention in Section B below. 
 
4.  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. 
 
For the naming convention  for PDFs, follow the specifics in Section C, Part 1.  Do not 
name a PDF using the volume/folder  naming convention as the two differ from each 
other. 
 
PDFs can only be added to the root level of the eCopy or under a volume/folder  as shown 
in Figures 3 through 12 below.  The root level of an eCopy is defined as the main level 
that you see when you open a CD, DVD, or flash drive.  If you have a volume-based 
submission,  then your PDFs must be named with the prefix count starting with 001_ in 
each volume (001_, 002_, etc.) as shown in Figure 10 and Figure 11 below. 
 
You may have a single PDF that comprises your eCopy if it meets all of the standards in 
Section C, including  the naming convention.   The single PDF must have a 001_ prefix.  
Please note that the file size limit,  in particular, must be taken into consideration  if you 
are contemplating  using a single PDF; see Section C, Part 4 below for details. 
 
17   
Aside from naming convention,  do not forget the other PDF standards that you need to 
meet:  (1) Adobe Acrobat PDF version 11 or below; (2) no embedded attachments; (3) no 
security settings; and (4) 50MB or smaller in size. 
 
5.  If you need to add non-PDFs to your eCopy, follow the instructions  in Section D.  Non-
PDF 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 packages. 
 
6.  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.   
 
7.  Mail your package to the DCC. 
 
Tip to Applicants: It is recommended that you provide adequate protection for the CD, DVD, or flash   
drive to prevent physical harm during transport.  Consider sending the package via private courier    
 
A. Company Cover Letter Requirements 
To meet the standards of the eCopy program, the cover letter must also include a signature (may 
be a wet (i.e., ink) signature or a valid digital  signature). 
 
Do not confuse a company cover letter with Form FDA 3514 (CDRH Premarket Review 
Submission  Cover Sheet).27  A company cover letter is the document that is on your letterhead 
and includes information  such as the purpose of your submission,  contact information  (including 
phone number and email address28), along with your signature.  When describing the purpose of 
your submission,  please use characteristics such as the submission  type (e.g., 510(k), PMA, Pre-
Submission),  stage of review (i.e., original,  amendment, supplement,  or report), and any other 
key words or information  that will assist in FDAs processing of the submission.   It is especially 
important to include the submission  tracking number if one has already been assigned and 
provided to you. 
 
Please also note that it is FDAs preference that responses to deficiencies identified  during 
submission  review not be incorporated into the company cover letter for ease of processing on 
both the part of the applicant and FDA.  Instead, please incorporate your responses into the main 
body of your submission. 
 
It is recommended that your company cover letter also be included as a PDF in your eCopy, but 
it is not required. 
 
                                                             
27 https://www.fda.gov/media/72421/download  
28 For additional information about email communications with CBER, please see SOPP 8119: Use of Email for 
Regulatory Communications, available at https://www.fda.gov/media/108992/download.  
18   
B. Volume or Non-Volume Structure Requirements 
The structure of an eCopy is highly  dependent on the overall size of the submission  and can be 
organized as a volume-based or non-volume-based  submission  as described below.   Although 
there is no maximum  total submission  size restriction, it is recommended that the total package 
submission  not exceed 1 GB to avoid possible delays in the submission  process.   
 
1.  Non-Volume-Based eCopy 
A non-volume  based eCopy is generally recommended for small submissions.   This eCopy 
structure includes one or more PDFs at the root level.  See Section C for required PDF file 
technical standards, particularly the required PDF naming convention.  Examples of 
non-volume-based  eCopies are shown in Figures 3 through 9 below.  
 
Figure 3:  Pre-Submission for which all content was was placed in a single PDF 
 
 
 
Figure 4:  PMA annual report for which all content was was placed in a single PDF 
 
 
 
Figure 5:  Original  510(k) submission  for which all content was placed in a single PDF 
 
 
19   
Figure 6:  Original  510(k) submission for which the content was added as individual  PDF 
files 
 
 
 
Figure 7:  Response to 510(k) RTA hold letter for which each item being responded to was 
added as an individual  PDF file 
 
 
 
20   
Figure 8:  Response to a 510(k) deficiency letter for which for which all content was placed 
in a single PDF 
 
 
 
Figure 9:  Response to a deficiency letter with each response as its own PDF 
 
 
 
2.  Volume-Based eCopy 
A volume-based eCopy is generally recommended for large or complex submissions  in order 
to facilitate the review of the submission.   This eCopy structure includes volumes (i.e., 
folders) at the root level.  Each volume,  in turn, includes one or more PDF files.  No other 
file types but PDFs can be placed in these volumes.  
 
A naming convention  for the volumes is required in order to assure that the system can create 
a sort order of the folders.  Without this sort order, the volumes will load in alphabetical 
order and, thus, be out of order. 
   
Each volume must have the following naming convention:   
  VOL_xxx_Descriptive Name (e.g., VOL_001_Mechanical Testing); or 
  VOL_xxx (e.g., VOL_001). 
 
The volume numbering must have a non-repeating, consecutive prefix.  The first 
volume has the prefix of VOL_001.  The second volume has a prefix of VOL_002, etc.  
If this volume naming convention is not followed, the eCopy will fail the loading 
process.   
 
The Descriptive Name part of the name of the volumes is optional.  However, if a 
Descriptive Name is used for a volume,  it should be descriptive of its content and meaningful 
to the reviewer.  The Descriptive Name can be up to 125 characters and can have spaces, 
dashes (not elongated dashes), underscores, and periods.  However, the Descriptive Name 
must not contain any of the following special characters or non-English letters or it will 
fail the loading process: 
 
 
21   
  tilde (~)    vertical bar (|); 
  asterisk (*);    forward slash (/); 
  elongated dash ();     backward slash (\); 
  apostrophe ();    greater than sign (>); 
  single quotation mark ();    less than sign (<); 
  double quotation marks ();    question mark (?); and 
  colon (:);    various other symbols (e.g., 
  pound sign (#);  ,*,,,,,TM).    
 
 
No Subfolders:  Under this eCopy structure, you must avoid placing any subfolders under a 
volume or the eCopy will fail the loading  process.  Even if you have non-PDF documents 
that are associated with a particular volume, you cannot embed the MISC FILES or 
STATISTICAL DATA folder within one of these volumes or it will fail the eCopy 
loading. 
 
NOTE:  A slight variation of a volume-based eCopy structure includes both volumes and at 
least one PDF file at the root level.  This structure commonly  occurs when an applicant adds 
a PDF of the company cover letter at the root level with all other PDFs organized under 
multiple  volumes.  See Figure 12 as one example. 
 
Examples of volume-based eCopies are shown in Figures 10 through 12 below. 
 
Figure 10:  Original PMA with the PDF content of VOL_001 and VOL_002 shown 
 
 
 
 
  
 
22   
Figure 11:  Original IDE with the PDF content of VOL_002 and VOL_003 shown 
 
 
 
 
 
 
 
 
Figure 12:  Response to RTA hold notification  for which the responses were grouped by 
topic  
 
 
 
 
 
C. 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. 
 
NOTE:  You may choose to have a single PDF that comprises the entire submission,  as long as 
all PDF file requirements below are met.  However, it is important to note that, as described in 
Section C, Part 4 below, no individual  PDF file may exceed 50MB.  Also keep in mind that large 
files take longer to open and search than do small files.  A very large file can also be difficult  for 
reviewers to work with, unless there are bookmarks or hyperlinks.  See Section C, Part 4 below 
for details. 
23   
 
1.  Specific PDF File Naming Convention 
Regardless of which eCopy structure is used, a naming convention  is required in order to 
assure that the loading system can create a sort order of PDF files that matches the order of 
files to be read by review staff.  Without this sort order, the files will load in alphabetical 
order and, thus, be out of order.   
 
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.  Keep in mind that if you have a volume-based submission,  you need to start over 
with the numbering  of the PDFs at 001_, 002_, etc. within each volume, as shown in Figure 
10 and Figure 11 above.  If this PDF file naming convention is not followed, the eCopy 
will fail the loading process.   
 
eCopies that are comprised of only a single PDF need to have the 3-digit prefix of 001_.   
 
The Descriptive Name part of the file name should be descriptive of its content and 
meaningful  to the reviewers.  The Descriptive Name can be up to 125 characters and can 
have spaces, dashes (not elongated dashes), underscores, and periods.  However, the 
Descriptive Name must not contain any of the following special characters or non-
English letters or it will fail the loading process: 
  tilde (~)    vertical bar (|); 
  asterisk (*);    forward slash (/); 
  elongated dash ();     backward slash (\); 
  apostrophe ();    greater than sign (>); 
  single quotation mark ();    less than sign (<); 
  double quotation marks ();    question mark (?); and 
  colon (:);    various other symbols (e.g., 
  pound sign (#);  ,*,,,,,TM).    
 
Examples of the PDF file names are throughout  the figures in Attachment 1. 
 
NOTE:  There is no correlation between the 3-digit file name prefix and the content or 
section location of the PDF file (e.g., a Section 10 response does not need a 010_ prefix).  
The 3-digit  prefix is only used by the loading software to load the PDFs in the correct order; 
otherwise, the system would load the PDF files alphabetically.   Depending on the Center 
involved,  the review staff may or may not even see the 3-digit  prefix after it is loaded into the 
official repository.   
 
This is why it is important that you have meaningful  Descriptive Names for your PDF files 
so that it is clear to review staff what the content of the file involves.   You can use the 
24   
Descriptive Name to also refer to Section or Tab numbers or review deficiency items.  It is 
recommended that you use Descriptive Names that are consistent with the language used in 
published  guidance documents.29  This will facilitate the review process by allowing  the 
reviewer to easily navigate through the information.  Examples of the varying Descriptive 
Names for the PDF files are throughout the figures in Attachment 1. 
 
2.  No Embedded Attachments or Attributes 
Our previous version of the eCopy software rejected PDF files with embedded attachments 
and attributes.  We found that the rejected PDF files were due to embedded attachments or 
attributes that the applicant did not intentionally  embed and of which they were unaware.  
Accordingly,  in order to streamline the eCopy processing, we have updated our software to 
not reject PDFs with embedded attachments or attributes.  However, do not intentionally 
embed attachments to PDF files because those embedded attachments are not 
compatible with our official repository, which can result in this information being 
missed during the review (e.g., we cannot search for content in an embedded 
attachment in a PDF; the attachment is removed when a PDF is downloaded from the 
official repository). 
 
NOTE:  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 Section VI.b above. 
 
3.  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.   
 
We found that all of the rejected PDF files were due to the first scenario (i.e., PDFs that 
could be opened but the content was protected).  Accordingly,  in order to streamline the 
eCopy processing, we will now allow PDFs with this type of security setting. However, we 
discourage submitting  PDF files with any type of security setting, because this affects our 
ability  to redact Confidential  Commercial Information efficiently. 
 
                                                             
29 Examples of published guidances with helpful descriptions of submission contents include FDA guidance, 
Refuse to Accept Policy for 510(k)s (https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/refuse-accept-policy-510ks), 
CBERs Guidance for Industry, Content and Format of Chemistry, Manufacturing and Controls Information and 
Establishment Description Information for a Biological In Vitro Diagnostic Product 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-and-format-chemistry-
manufacturing-and-controls-information-and-establishment-description-0), and Guidance for the Content of 
Premarket Submissions for Software Contained in Medical Devices (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-
devices), as well as many others. 
25   
However, you must not include any PDF that requires a password to open it or we will 
put the submission on eCopy hold.  eCopies must not include PDF files that require 
passwords to view the content. 
 
4.  PDF File Size Limited to 50MB or Below 
While there is no limitation  on the total size of an eCopy, each PDF file must be limited  to 
50MB or smaller.   
 
Be careful to look at the file size after you have added it to your eCopy media (CD, DVD, or 
flash drive), as shown in Figure 13.  The file size shown here is what the loading  software 
will use to determine if the size technical standard has been met.  Do not use the size limit  in 
the file properties or the size limit  that appears when you hover the cursor over a PDF file, as 
both of these sizes will be smaller and will  mislead you as to whether or not the PDF size 
technical standard has been met.   
 
Figure 13:  PDF that has exceeded the 50MB size limit  and will fail the eCopy loading 
process 
 
 
If a file size is greater than 50MB, then you must split the contents into multiple  files.  We 
recommend that you name the files in a way that clearly reflects that it was originally  a single 
file that was split into multiple  files.  One suggested way of accomplishing  this is by naming 
the files as Parts 1 and 2 as shown in Figure 14 below. 
 
Figure 14: Example of how you can split and label a PDF greater than 50MB into multiple 
files 
 
 
5.  Adobe Acrobat PDF Version 11 or Below 
Only eCopies submitted using Adobe Acrobat 11 or below will be accepted.  As we test and 
validate new versions of Adobe Acrobat, we will update this guidance accordingly.  If you 
have a new version of Adobe Acrobat greater than 11, you must save the PDF as a reduced 
size PDF or the eCopy will fail the loading  process. 
 
D. Requirements for How to Add Non-PDF Files 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.    
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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 is no size limit  for a zip file. 
  Statistical data, videos, and images (e.g., CTs, x-rays) are typically  large files.  This, in 
turn, will lead to excessively large submission  sizes.  Although  there is not a size limit  for 
the zip files discussed in this section, FDA strongly recommends that you take any 
appropriate and feasible steps to reduce the file sizes.  For example, videos can be 
compressed to much smaller sizes than that of the original  recording.  It is important to 
recognize that very large file sizes take much longer to load and may present viewing 
issues with the FDA review staff.  Whenever possible, make the non-PDFs that you zip 
into reasonably small file sizes.  If you have multiple  large non-PDFs, split them into 
separate zip files. 
  Add the zip file(s) to the STATISTICAL DATA or MISC FILES folder. 
 
If you do not follow these requirements, the eCopy will fail the loading process.   
 
NOTE:  Depending on the type of non-PDF files that you want to add to your eCopy, you may 
determine that it is appropriate to have both the STATISTICAL DATA and MISC FILES 
folders in your eCopy.  Figure 16 below illustrates this. 
 
Below describes the type of appropriate information  as part of a STATISTICAL DATA or 
MISC FILES folder. 
 
1.  STATISTICAL DATA folder 
The STATISTICAL DATA folder is used to add types of statistical information,  including 
metadata, data line listings  and program codes, to the eCopy in their native formats, such as, 
but not limited  to:  SAS; XPORT; XML; SGML; S-Plus; R files; ASCII; Molfiles;  and 
Excel.  Metadata includes data dictionaries  and terminologies,  formats, annotated case report 
forms, statistical analysis details, and any other information  that contributes to understanding 
and using the data.  There are no restrictions on the format used; however, file formats that 
include variable labels and dictionary  information  (such as SAS XPORT) are encouraged.30   
 
Do not forget to zip the content before placing it within the STATISTICAL DATA 
folder. 
 
                                                             
30 For further information, see the final guidance, Providing Regulatory Submissions in Electronic Format  
Standardized Study Data (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-
regulatory-submissions-electronic-format-standardized-study-data). 
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2.   MISC FILES folder 
The MISC FILES folder is used to add types of files that that cannot be submitted (or 
should not be submitted) in PDF format and are not statistical in nature (e.g., videos, x-rays, 
machine readable software source code).  These miscellaneous files may be included  in the 
eCopy under the MISC FILES folder in their native formats, such as, but not limited  to: .gif; 
.tif; .jpg; .avi; .mpeg; .wmv; and .txt.  There are no restrictions on the native format.   
 
In addition,  for the purposes of streamlining  the review process, FDA encourages you to also 
include,  under the MISC FILES folder, Microsoft Word versions of certain documents or 
pieces of information  that were also provided in the main body of the eCopy as PDFs.  In 
other words, include the PDF version in the main body of the eCopy as part of the volume-
based or non-volume-based  eCopy structure and include a Microsoft Word version in the 
MISC FILES folder to assist the reviewer.  Do not include Microsoft Word versions in lieu 
of the PDF versions.  Documents such as those listed below are commonly  requested via 
Interactive Review to enable FDA feedback to the applicant and/or completion  of the review.  
Inclusion  of these documents within the MISC FILES folder in an eCopy can help to 
minimize  potential  delays during the substantive review of the submission.   Suggested 
documents include, as applicable: 
  Labeling for any submission  [preferably with each piece (e.g., physician labeling, 
patient labeling,  operators manual) as a separate file]; 
  Predicate device comparison table for 510(k)s; 
  510(k) Summary;  
  Summary of Safety and Effectiveness Data (SSED) for PMAs; and 
  Summary of Safety and Probable Benefit (SSPB) for HDEs.  
 
There are no limitations/restrictions  on the naming convention for any files you add to the zip 
files for the MISC FILES folder.  However, for Microsoft Word documents included  in the 
MISC FILES folder, it is recommended that you use a naming convention  similar to the PDF 
equivalent files so that reviewers can easily make the correlation. 
 
Do not forget to zip the content before placing it within the MISC FILES folder. 
 
Figure 15 provides an example of non-volume-based  eCopy with a MISC FILES.  Figure 16 
provides an example of a volume-based eCopy that includes both the STATISTICAL DATA and 
MISC FILES folders.  Both figures show the zip file(s) directly under the folder. 
 
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Figure 15:  Example of a non-volume-based  submission  with a MISC FILES folder 
   
   
Figure 16:  Example of a volume-based submission  with MISC FILES and STATISTICAL 
DATA folders 
 
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