Contains Nonbinding Recommendations 
Providing Regulatory Submissions 
for Medical Devices in Electronic 
Format  Submissions Under Section 
745A(b) of the Federal Food, Drug, 
and Cosmetic Act 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on July 15, 2020. 
The draft of this document was issued on September 26, 2019. 
For questions about this document regarding CDRH-regulated devices, contact the Office of 
Regulatory Programs at 301-796-5640 or esubpilot@fda.hhs.gov. For questions about this 
document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and 
Development (OCOD) by email at ocod@fda.hhs.gov or at 800-835-4709 or 240-402-8010. 
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 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2019-D-3769.Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies 
CDRH 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 19031 and complete title of the guidance in the request. 
CBER 
Additional copies are 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 email, ocod@fda.hhs.gov or from the Internet at https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.  Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction ............................................................................................................................. 1 
II.  Background .............................................................................................................................. 3 
III.  Submissions Under section 745A(b) of the FD&C Act .......................................................... 3 
A.  Which submissions must be submitted solely in electronic format? ....................................... 4 
B.  Will FDA issue waivers from the submission solely in electronic format requirements? ...... 5 
C.  Which submissions are exempted from the electronic format requirements? ......................... 5 
D.  How will FDA implement specific submissions solely in electronic format requirements .... 6 
E.  When will submissions solely in electronic format be required? ............................................ 7  Contains Nonbinding Recommendations 
Providing Regulatory Submissions 
for Medical Devices in Electronic 
Format  Submissions Under Section 
745A(b) of the Federal Food, Drug, 
and Cosmetic Act 
______________________________________________________________________________ 
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 
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by section 
207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-521), requires that pre-
submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 
515(f), 520(g), 520(m), or 564 of the FD&C Act or section 351 of the Public Health Service Act, 
and any supplements to such pre-submissions or submissions, including appeals of those 
submissions, be submitted in electronic format specified by the Food and Drug Administration 
(FDA or the Agency) beginning on such date as specified by FDA in final guidance. It also 
mandates that FDA issue draft guidance not later than October 1, 2019, and a final guidance not 
later than 1 year after the close of the public comment period, providing for further standards for 
the submission by electronic format, a timetable for establishment of these further standards, and 
criteria for waivers of and exemptions from the requirements.2 In addition, in the Medical Device 
User Fee Amendments of 2017 (MDUFA IV) Commitment Letter3 from the Secretary of Health 
                                                
1 https://www.govinfo.gov/content/pkg/PLAW-115publ52/html/PLAW-115publ52.htm. 
2 See 745A(b)(3)(B). 
3 See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 2017) (Food and Drug Administration User Fee 
Reauthorization), also available at https://www.fda.gov/media/102699/download. 
1  Contains Nonbinding Recommendations 
and Human Services to Congress, FDA committed to developing electronic submission 
templates that will serve as guided submission preparation tools for industry to improve 
submission consistency and enhance efficiency in the review process and [by] FY [fiscal year] 
2020, the Agency will issue a draft guidance document on the use of the electronic submission 
templates. In addition, the Commitment Letter states that [n]o later than 12 months after the 
close of the public comment period, the Agency will issue a final guidance. This guidance is 
intended to satisfy the final guidance documents referenced in section 745A(b)(3) and the 
MDUFA IV Commitment Letter. 
The Agency has concluded that it is not feasible to describe and implement the electronic 
format(s) that would apply to all the submissions covered by section 745A(b)(3) in one guidance 
document. Accordingly, this guidance describes how FDA interprets and plans to implement the 
requirements of section 745A(b)(3), while individual guidances will be developed to specify the 
formats for specific submissions and corresponding timetables for implementation. Specifically, 
this guidance discusses (1) the submission types that must be submitted electronically, (2) the 
timetable and process for implementing the requirements, and (3) criteria for waivers of and 
exemptions from the submissions in electronic format requirements. 
Under the process described in this guidance, FDA will periodically issue guidances relating to 
the submission in electronic format guidelines for certain submission types to the Center for 
Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research 
(CBER). These submission types are identified in section III.A of this guidance. FDA believes 
that issuing this guidance related to submissions solely in an electronic format will harmonize 
and streamline the process for implementing the various requirements for submission in 
electronic format under section 745A(b) of the FD&C Act. The process described in this 
guidance is also intended to provide a meaningful opportunity for the public to comment on 
guidances that the Agency intends to issue pursuant to section 745A(b) of the FD&C Act. 
In section 745A(b)(3) of the FD&C Act, Congress granted explicit statutory authorization to 
FDA to specify in guidance the electronic submissions requirement by providing standards, 
criteria for waivers and exemptions, and a timetable for such submissions. Accordingly, to the 
extent that this document provides such requirements under section 745A(b)(3), indicated by the 
use of mandatory words, such as must or required, this document is not subject to the usual 
restrictions in section 701(h) of the FD&C Act and FDAs good guidance practices (GGPs) 
regulations, such as the requirement that guidances not establish legally enforceable 
responsibilities. See 21 CFR 10.115(d). 
This document provides guidance on FDAs interpretation of the statutory requirement for 
submission in electronic format; this document also contains guidance on additional submission 
types for which submission in electronic format is anticipated to be recommended. Therefore, to 
the extent that this guidance describes recommendations that are not standards, timetable, or 
criteria for waivers and exemptions under section 745A(b)(3), 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. You can use an alternative approach 
2 Contains Nonbinding Recommendations 
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 make sure 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, timetable, or criteria for waivers and exemptions pursuant to section 745A(b) 
of the FD&C Act, it will have binding effect. 
II.  Background 
The Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted on July 9, 
2012, amending the FD&C Act by adding section 745A, which addresses submissions in 
electronic format. Medical device submissions are addressed in section 745A(b), while section 
745A(a) applies to drug and biological product submissions.4 Section 745A(b) of the FD&C Act 
was amended by FDARA adding section 745A(b)(3). 
Section 745A(b)(3)(A) of the FD&C Act authorizes FDA to specify in guidance that submissions 
(described in section III.A below) are required to be submitted solely in electronic format. 
Section 745A(b)(3)(B) of the FD&C Act states that FDA shall issue draft guidance providing for 
additional standards for submission in electronic format, a timetable for these future standards, 
and criteria for waivers and exemptions: 
(i)  any further standards for submission by electronic forma required under 
subparagraph (A); 
(ii)  a timetable for the establishment by the Secretary of such further 
standards; and 
(iii)  criteria for waivers of and exemptions from the requirements of this 
subsection. 
Section 745A(b)(3)(C) of the FD&C Act provides that FDA will issue final guidance no later 
than 1 year following the close of the public comment period for the draft guidance. 
III.  Submissions Under section 745A(b) of the FD&C Act 
As discussed in section II above of this guidance, the requirements of section 745A(b) of the 
FD&C Act apply to all submissions listed in section A below. In this section, we discuss our 
                                                
4 The electronic format for submissions requirements of section 745A(a) fall outside the scope of this guidance and 
are not discussed in this guidance. 
3 Contains Nonbinding Recommendations 
interpretation of section 745A(b); specifically, its scope, the timetable and process for 
implementing the requirements under section 745A(b), and waivers of and exemptions from the 
submissions in electronic format requirements. 
A.  Which submissions must be submitted solely in electronic 
format? 
In accordance with section 745A(b)(3) of the FD&C Act, submission solely in electronic format 
is required for the following submission types: 
  Premarket notification submissions (510(k)s) under section 510(k); 
  Evaluation of automatic class III designation request (De Novos) under section 513(f)(2); 
  Premarket approval applications (PMAs), including Transitional PMAs under section 
515(c), 515(d); 
  This includes all PMA submission types, including, but not limited to, original 
PMAs, panel-track supplements, 180-day supplements, real-time review 
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 under 515(c)(4); 
  Product development protocols (PDPs) under section 515(f); 
  Investigational device exemption (IDE) applications under section 520(g); 
  This includes all IDE application types including original IDEs, IDE reports, IDE 
supplements and amendments to each of those [see Exemptions below].5
  Humanitarian device exemption (HDE) applications under section 520(m); 
  This includes all HDE application types, including, but not limited to, original 
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)6 under section 564; 
  Certain investigational new drug applications (INDs) under section 351 of the Public 
Health Service (PHS) Act; 
  Applicable only to those INDs required prior to the submission of a biologics 
license applications (BLA) for devices that are regulated by CBER as biological 
                                                
5 For a description of IDE application 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. 
6 For more information on Emergency use authorizations, refer to the FDA guidance, Emergency Use 
Authorization of Medical Products, at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/emergency-use-authorization-medical-products-and-related-authorities. 
4 Contains Nonbinding Recommendations 
products. Such INDs are generally those intended for use in screening donated 
blood for transfusion transmissible diseases. 
  Certain BLAs under section 351 of the PHS Act; 
  Applicable only to those devices that are regulated by CBER as biological 
products 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 
  Pre-submissions 
  While section 745A(b) does not require the submission of Q-submission types 
other than pre-submissions to be made in an electronic format, FDA recommends 
that all Q-submissions be submitted in electronic format to facilitate efficient 
review. Please refer to the Q-submission Guidance7 for additional information. 
Electronic format 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 (e.g., a change in correspondent) or a multi-volume 
submission, the submissions in electronic format requirements apply. A submission that is not in 
the electronic format(s) described in the relevant guidance document will not be filed or received, 
unless it has been exempted from the electronic submission requirements or the electronic 
submission requirements have been waived with respect to that submission. 
B.  Will FDA issue waivers from the submission solely in 
electronic format requirements? 
The statute allows FDA to set forth criteria for waivers of the electronic submission 
requirements. The criteria for any waivers, if available, will be discussed in the individual 
guidances for specific submissions. 
C.  Which submissions are exempted from the electronic 
format requirements? 
                                                
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
5 Contains Nonbinding Recommendations 
Section 745A(b)(3)(B) authorizes FDA to establish criteria for exemptions from the submission 
solely in electronic format requirements. As a general matter, the following types of IDE 
submissions will be exempt from the requirements under section 745A(b)(3): 
  Expanded access compassionate use requests and emergency use reports Adverse event 
reports (all types, e.g., serious, malfunctions, etc.) 
Although submission in electronic format will not be required for these submission types, as per 
this exemption, FDA encourages submission in electronic format of these submissions, as 
submission templates become available, to facilitate the review process. 
Additional exemptions, if applicable, will be discussed in the individual guidances for specific 
submissions. 
Although submission in electronic format is not required under section 745A(b) of the FD&C 
Act, FDA may also identify and recommend formats for electronic submission for the following: 
  Master Access Files (MAFs); 
  513(g) Requests for Information (513(g)s); and 
  Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization requests 
(CLIA Record; CR) and CLIA Waiver Applications (CW).8
Submission in electronic format for these submission types would be on a voluntary basis, as 
submission templates become available. 
D.  How will FDA implement specific submissions solely in 
electronic format requirements 
FDA intends to use the following process to specify the electronic formats for submissions under 
section 745A(b): 
1.  Individual draft guidance documents will be developed to specify the electronic 
formats, subject matter, and scope of applicability for submissions under section 
745A(b). We intend to release these guidance documents sequentially, allowing for 
an eventual phased implementation. The draft guidance documents will be posted on 
FDAs Web site. 
2.  The Agency will publish a notice in the Federal Register announcing the availability 
on the FDA Web site of a new or revised submission in electronic format guidance. 
The notice will identify a comment period for the draft guidance. 
                                                
8 For additional information about CR and CW submissions, please see FDAs guidance Administrative Procedures 
for CLIA Categorization, at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/administrative-procedures-clia-categorization. 
6 Contains Nonbinding Recommendations 
3.  Once the Agency has completed its review of the draft guidance, including 
consideration of comments submitted (if any), the Agency will publish a notice in the 
Federal Register announcing the availability on the FDA Web site of the final 
electronic format guidance. The notice and/or guidance will provide a date on which 
the new submissions in electronic format will be required for the submission types 
identified in the guidance document. We intend to consider the time period necessary 
to transition to use of the electronic format when identifying the date on which 
electronic format will be required. FDA will post the final guidance on its Guidance 
Web page. 
4.  Subsequent revisions or updates to specified formats will be announced on the FDA 
Web site and published in the Federal Register. The notice and/or guidance will 
provide a date on which the revised or updated electronic format for submissions 
specified in the guidance will be required. 
E.  When will submissions solely in electronic format be 
required? 
As described above, individual guidance documents will be developed to specify the electronic 
format for each submission type under 745A(b) or identified in this guidance. The required 
format(s) for the specific submissions and corresponding timetable(s) for implementation will be 
specified in these individual guidances. Once an individual guidance is finalized and published on 
FDAs Web site, and the timetable for implementation described in that guidance has passed, the 
guidance will be considered to have binding effect and the electronic format(s) specified in that 
guidance must be used for submissions identified in section III.A above. 
7