Contains Nonbinding Recommendations 
 
Electronic Submission Template for 
Medical Device 510(k) Submissions 
 
Guidance for Industry and 
Food and Drug Administration Staff 
 
Document issued on October 2, 2023. 
 
Document originally issued on September 22, 2022. 
 
For questions about this document regarding CDRH-regulated devices, contact ORP: 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) 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 
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-2021-D-0872. 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 email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
GUI00019006 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., 
WO71, Room 3128, Silver Spring, MD 20993, 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 
 
  Introduction ............................................................................................................................. 1 
  Background ............................................................................................................................. 2 
  Scope ....................................................................................................................................... 4 
  Significant Terminology ......................................................................................................... 4 
  Current Electronic Submission Template Structure, Format, and Use ................................... 5 
A.  Structure of the current 510(k) Electronic Submission Template .................................... 6 
  Electronic Submission Template Waivers, Exemptions, and Timing .................................. 11 
A.  Waivers and Exemptions From Electronic Submission Requirements .......................... 11 
B.  When Electronic Submissions Will Be Required .......................................................... 12 
 
  Contains Nonbinding Recommendations 
 
Electronic Submission Template for 
Medical Device 510(k) 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.  
 
  Introduction 
The Food and Drug Administration (FDA or Agency) is issuing this guidance document to 
introduce submitters of premarket notification (510(k)) submissions to the Center for Devices 
and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to 
the current resources and associated content developed and made publicly available to support 
510(k) electronic submissions to FDA. This guidance is intended to represent one of several 
steps in meeting FDAs commitment to the development of electronic submission templates to 
serve as guided submission preparation tools for industry to improve submission consistency and 
enhance efficiency in the review process.1 This guidance facilitates the implementation of the 
FDAs mandate under 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-
522) to provide 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.  
 
FDAs guidance document Providing Regulatory Submissions for Medical Devices in 
Electronic Format  Submissions Under Section 745A(b) of the Federal Food, Drug, and 
Cosmetic Act3 (hereafter referred to as the 745A(b) device parent guidance) provides a 
process for the development of templates to facilitate the preparation, submission, and review of 
regulatory submissions for medical devices solely in electronic format. As described in the 
745A(b) device parent guidance, FDA plans to implement the requirements of section 
745A(b)(3) of the FD&C Act with individual guidances specifying the formats for specific 
 
1 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. 
2 https://www.govinfo.gov/content/pkg/PLAW-115publ52/html/PLAW-115publ52.htm. 
3 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-
medical-devices-electronic-format-submissions-under-section-745ab. 
1  Contains Nonbinding Recommendations 
 
submissions and corresponding timetables for implementation. This guidance provides such 
information for 510(k) electronic submissions solely in electronic format.  
 
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) of the FD&C 
Act, indicated by the use of mandatory words, such as must or required, this guidance 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 
electronic submissions solely in electronic format. 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) of the FD&C Act, 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 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. 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 has binding effect.  
 
For those provisions not identified as binding, the contents of this document do not have the 
force and effect of law. This document, other than the binding provisions, is intended only to 
provide clarity to the public regarding existing requirements under the law. FDA guidance 
documents, including this guidance, should be viewed only as recommendations, unless specific 
regulatory or statutory requirements are cited. The use of the word should in Agency guidance 
means that something is suggested or recommended, but not required. 
 
  Background 
Section 745A(b) of the FD&C Act, amended by section 207 of FDARA, requires that pre-
submissions and submissions for devices under sections 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 FDA 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 
2  Contains Nonbinding Recommendations 
 
establishment of these further standards, and criteria for waivers of and exemptions from the 
requirements.4  
 
In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment 
Letter5 from the Secretary of Health 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 MDUFA IV 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. The 745A(b) device parent guidance was intended to satisfy the final 
guidance documents referenced in section 745A(b)(3) of the FD&C Act and the MDUFA IV 
Commitment Letter. 
 
In September 2018, as a first step in the transition to 510(k) electronic submissions solely in 
electronic format, FDA launched the Quality in 510(k) Review Program Pilot6 for the 
submission of Traditional and Abbreviated 510(k)s for certain devices using the eSubmitter 
electronic submission template. The eSubmitter template was developed by FDA as an optional 
free tool consisting of a collection of questions, text, logic, and prompts that guides a user 
through preparation of a 510(k) submission in electronic format. Upon completion, the resulting 
submission package would contain the structured and unstructured data of a complete 510(k)7 
submission. The pilot helped facilitate the production of well-organized submissions, however, 
as of May 30, 2021, FDA concluded the Quality in 510(k) Review Program Pilot, along with use 
of the eSubmitter electronic submission template for preparation of a 510(k) submission in 
electronic format. 
 
In February 2020, to support the next step in transition to 510(k) electronic submissions solely in 
electronic format, CDRH developed and has piloted the use of the electronic Submission 
Template And Resource (eSTAR) electronic submission template through launching the eSTAR 
Pilot Program.8 CBER began piloting the use of eSTAR in June 2022.9 Based on the experience 
with the eSubmitter software, FDA developed eSTAR to include similar benefits as eSubmitter, 
 
4 See section 745A(b)(3)(B) of the FD&C Act. 
5 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. 
6 Information on the Quality in 510(k) Review Program Pilot is available at: https://www.fda.gov/medical-
devices/premarket-notification-510k/510k-program-pilots#quik. 
7 The 510(k) regulations at 21 CFR 807.87 to 807.100 provide greater detail regarding the specific information that 
each premarket notification submission must contain. For example, the submission must include proposed labeling 
(21 CFR 807.87(e)), a statement regarding the similarities and differences between the device and others of 
comparable type (21 CFR 807.87(f)), supporting data (21 CFR 807.87(f) and 807.100(b)(2)(ii)(B)), and FDA may 
request any additional information necessary to determine whether the device is substantially equivalent when the 
information provided is insufficient to enable such a determination (21 CFR 807.87(m)).  
8 See Notice and request for comments, 85 FR 11371 (Feb. 27, 2020), available at 
https://www.federalregister.gov/d/2020-03945. The FDA eSTAR website is available at 
https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program.  
9 See Notice and request for comments, 87 FR 36861 (June 21, 2022), available at 
https://www.federalregister.gov/documents/2022/06/21/2022-13210/improving-510k-submission-preparation-and-
review-center-for-biologics-evaluation-and-research. 
3  Contains Nonbinding Recommendations 
 
as well as additional benefits. Similar to eSubmitter, eSTAR includes the following benefits: 
automation (e.g., form construction, autofilling); content and structure that is complementary to 
CDRH internal review templates; integration of multiple resources (e.g., guidances, databases); 
guided construction for each submission section; automatic verification; and it is free to use. In 
contrast to eSubmitter, eSTAR incorporates additional benefits, including: use of a familiar 
software application, Adobe Acrobat Pro, and not a proprietary application that requires training; 
more dynamic functionality, such as support for images and messages with hyperlinks; 
supporting the creation of Supplements and certain Amendments; mobile device compatibility 
for certain dynamic PDF features; ability for the submitter to add comments to the PDF after 
flattening the dynamic version, for the purposes of helping submission preparation; and that 
eSTAR content and logic fully mirrors the internal templates used by reviewers to review 
devices, therefore supporting completeness of the submission content and facilitating more 
efficient review. During the transition time up to the point when 510(k) electronic submissions 
will be required (see Section VI.B below), anyone can voluntarily use eSTAR for 510(k) 
submissions. As described below, eSTAR is the only electronic submission template currently 
available to enable 510(k) electronic submissions. 
 
  Scope 
This guidance describes the technical standards associated with preparation of the electronic 
submission template for 510(k)s that enable submission of the 510(k) electronic submission 
solely in electronic format. The electronic submission template includes the information and 
guided prompts FDA believes will best facilitate the collection and assembly of the necessary 
elements of a complete submission, as required by regulation or essential to FDAs substantive 
review of the 510(k) submission. This guidance is not intended to specify the user-interface and 
detailed content of the eSTAR, but instead is limited to establishing the 510(k) electronic format 
and standards for complying with section 745(A)(b)(3) of the FD&C Act.  FDA intends to 
implement new versions of eSTAR as relevant policies change. FDA also has an ongoing 
process to collect and consider public comments and stakeholder feedback, which is described on 
FDAs website.10 
 
  Significant Terminology 
For the purpose of this document the following significant terminology is described: 
 
eCopy: An electronic copy is a duplicate device submission in electronic format of the 
previously required paper copy submission sent to FDA.11 An electronic copy is not considered 
to be an electronic submission, as defined below. 
 
 
10 See FDAs website on the eSTAR program at https://www.fda.gov/medical-devices/how-study-and-market-your-
device/voluntary-estar-program.  
11 See 84 FR 68334 and the FDA guidance eCopy Program for Medical Device Submissions at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions. 
4  Contains Nonbinding Recommendations 
 
eSubmitter: A freely available FDA software program12 that contains electronic submission 
templates, including the eSubmitter electronic submission template that was available for 
preparing 510(k) eSubmissions from September 2018, through May 2021, and is no longer 
available for use to prepare 510(k) submissions.  
 
Electronic Submission (eSubmission): The submission package produced by an electronic 
submission template13 that contains the data of a complete submission. 
 
eSTAR (electronic Submission Template And Resource): An electronic submission 
template14 built within a structured dynamic PDF that guides a user through construction of an 
eSubmission. eSTAR is the only type of electronic submission template that is currently 
available to facilitate the preparation of 510(k) submissions as eSubmissions. For simplicity, the 
electronic submission created with this electronic submission template is often referred to as an 
eSTAR.  
 
Electronic submission template: A guided submission preparation tool for industry. An 
electronic submission template walks industry through the relevant contents and components for 
the respective premarket submission type and device to facilitate submission preparation and 
enhance consistency, quality, and efficiency in the premarket review process.15  
 
Structured data: Data and content that are captured in the fields, dropdown boxes, checkboxes, 
etc., within the electronic submission template. 
 
Unstructured data: Data and content that are submitted as attachments to the electronic 
submission template. 
 
  Current Electronic Submission Template Structure, 
Format, and Use 
The electronic submission template, eSTAR, is the only currently available electronic 
submission template at this time to facilitate the preparation of 510(k) electronic submissions. 
eSTAR consists of a collection of questions, text, logic, and prompts within a template that 
guides a user through construction of a complete 510(k) submission. eSTAR is highly 
automated, includes integrated databases (e.g., FDA product codes,16 FDA-recognized voluntary 
consensus standards17), and includes targeted questions designed to collect specific data and 
information from the submitter. eSTAR also includes applicable links to regulations, relevant 
guidances, and other resources for the submitters reference. Finally, eSTAR is structured to 
 
12 https://www.fda.gov/industry/fda-esubmitter. 
13 See 84 FR 68334 and the FDA guidance eCopy Program for Medical Device Submissions at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions. 
14 The 510(k) eSTAR can be downloaded for free on FDAs website at https://www.fda.gov/medical-devices/how-
study-and-market-your-device/voluntary-estar-program. 
15 https://www.fda.gov/media/102699/download. 
16 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm. 
17 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
5  Contains Nonbinding Recommendations 
 
collect and assemble content in the 510(k) submission as an electronic submission that closely 
follows the content of the SMART 510(k) review memo template18 used by CDRH reviewers.  
 
Given that an electronic submission properly prepared with an electronic submission template 
should represent a complete submission,19 eSTAR submissions are not anticipated to undergo a 
refuse to accept (RTA) process. The CDRH Portal will automatically verify that the eSTAR is 
complete, and therefore we do not expect to receive incomplete 510(k) eSTARs. However, FDA 
intends to employ a virus scanning and technical screening process for an eSTAR. A technical 
screening process is a process for verifying that eSTAR responses accurately describe the 
device(s) (e.g., there are, in fact, no tissue contacting components if indicated as such) and that 
there is at least one relevant attachment per each applicable attachment-type question (e.g., a 
Software Description attachment is included in response to the Software Description question if 
software is applicable to the submission). The technical screening process is anticipated to occur 
within 15 days of FDA receiving the 510(k) eSTAR. FDA intends to only begin the technical 
screening for 510(k) electronic submissions where the appropriate user fee has been paid. If the 
eSTAR does not pass technical screening, FDA will notify the submitter via email20 and identify 
the incomplete information, and the 510(k) will be placed and remain on hold until a complete 
replacement eSTAR is submitted to FDA. If a replacement eSTAR is not received within 180 
days of the date of technical screening deficiency notification, FDA will consider the 510(k) to 
be withdrawn and the submission will be closed in the system. The technical screening review 
time does not impact the review clock for files that pass the technical screening. For a 
submission that passes technical screening, the review clock starts on the day the submission was 
received by FDA.  
 
A.  Structure of the current 510(k) Electronic Submission 
Template 
In Table 1 below, is a high-level overview of the structure of the current electronic submission 
template for 510(k)s,21 including a summary of the anticipated submission content provided by 
the submitter in each section:22 
 
 
18 For more information on the SMART 510(k) review memo template, please see FDA Has Taken Steps to 
Strengthen The 510(k) Program available at https://www.fda.gov/media/118500/download or Improve 510(k) 
Submission Quality available at https://www.accessdata.fda.gov/scripts/fdatrack/view/track_project.cfm?
program=cdrh&id=CDRH-ODE-Improve-510k-Submission-Quality. 
19 After a submitter completes all necessary sections in their eSTAR file correctly, the status message at the top of 
the PDF will indicate eSTAR Complete to represent a complete submission. 
20 For additional information about email communications with CBER, please see the SOPP 8119: Use of Email for 
Regulatory Communications, available at https://www.fda.gov/media/108992/download.  
21 As indicated above, FDA intends to employ a technical screening process to verify that electronic submission 
template responses accurately describe the device. 
22 Throughout completion of the eSTAR, submitters can add attachments as unstructured data, including but not 
limited to documents, PDFs, images, and videos that the submitter believes are pertinent to the review of their 
device. In addition, eSTAR will prompt for any documents that are needed. For example, when the use of clinical 
testing to support the submission is affirmatively indicated, eSTAR will automatically prompt for the attachment of 
clinical testing documents and any applicable financial certifications or disclosure statements. These attachments 
appear within the applicable bookmark of the eSTAR PDF when viewed by the submitter or FDA.  
6  Contains Nonbinding Recommendations 
 
Table 1: Structure of the current eSTAR 510(k) Electronic Submission Template 
Information Requested  Description 
Submission Type  Identification of key information that may be useful to FDA in the 
initial processing and review of the 510(k) submission, including 
content from current Form FDA 3514, Section A.23 
Cover Letter / Letters of  Attach a cover letter and any documents that refer to other 
Reference  submissions. 
Applicant Information  Information on the applicant and correspondent, if applicable, 
consistent with content from current Form FDA 3514, Sections B 
and C.  
Pre-Submission  Information on prior submissions for the same device included in 
Correspondence & Previous  the current submission, such as submission numbers for a prior not 
Regulator Interaction  substantially equivalent (NSE) determination, prior deleted or 
withdrawn 510(k), Q-Submission, Investigational Device 
Exemption (IDE) application, premarket approval (PMA) 
application, humanitarian device exemption (HDE) application, or 
De Novo classification request. 
Consensus Standards24  Identification of voluntary consensus standard(s) used, if 
applicable. This includes both FDA-recognized and non-
recognized consensus standards. 
 
23 https://www.fda.gov/media/72421/download. 
24 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-
conformity-assessment-program. 
7  Contains Nonbinding Recommendations 
 
Information Requested  Description 
Device Description25  Identification of listing number if listed with FDA. 
 
Descriptive information for the device, including a description of 
the technological characteristics of the device including materials, 
design, energy source, and other device features, as defined in 
section 513(i)(1)(B) of the FD&C Act and 21 CFR 
807.100(b)(2)(ii)(A). Descriptive information also includes a 
description of the principle of operation for achieving the intended 
effect and the proposed conditions of use, such as surgical 
technique for implants; anatomical location of use; user interface; 
how the device interacts with other devices; and/or how the device 
interacts with the patient. 
 
Information on whether the device is intended to be marketed with 
accessories. 
 
Identification of any applicable device-specific guidance 
document(s) or special controls for the device type as provided in a 
special controls document (or alternative measures identified that 
provide at least an equivalent assurance of safety and 
effectiveness) or in a device-specific classification regulation, 
and/or performance standards. See The 510(k) Program: 
Evaluating Substantial Equivalence in Premarket Notifications 
[510(k)].26 
Proposed Indications for Use  Identification of the proposed indications for use of the device. The 
(Form FDA 3881)27  term indications for use, as defined in 21 CFR 814.20(b)(3)(i), 
describes the disease or condition the device will diagnose, treat, 
prevent, cure, or mitigate, including a description of the patient 
population for which the device is intended.28 
Classification29  Identification of the classification regulation number that seems 
most appropriate for the subject device, as applicable. 
 
25 FDAs regulations require manufacturers to include in their 510(k)s [a] description of the device that is the 
subject of the premarket notification submission, such as might be found in the labeling or promotional material for 
the device, including an explanation of how the device functions, the scientific concepts that form the basis for the 
device, and the significant physical and performance characteristics of the device, such as device design, material 
used, and physical properties. 21 CFR 807.92(a)(4); see also 21 CFR 807.87(f). 
26 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k. 
27 https://www.fda.gov/media/124401/download. 
28 We have a long-standing policy of applying the definition of indications for use in the PMA regulation at 21 CFR 
814.20(b)(3)(i) in the same way in the 510(k) context. 
29 21 CFR 807.87(c). 
8  Contains Nonbinding Recommendations 
 
Information Requested  Description 
Predicates and Substantial  Identification of a predicate device (e.g., 510(k) number, De Novo 
Equivalence30  number, reclassified PMA number, classification regulation 
reference, if exempt and limitations to exemption are exceeded, or 
statement that the predicate is a preamendments device).  
 
The submission should include a comparison of the predicate and 
subject device and a discussion why any differences between the 
subject and predicate do not impact safety and effectiveness [see 
section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)]. A 
reference device should also be included in the discussion, if 
applicable. See The 510(k) Program: Evaluating Substantial 
Equivalence in Premarket Notifications [510(k)].31 
Design/Special Controls,  Applicable to Special 510(k) submissions only. 
Risks to Health, and   
Mitigation Measures 
Identification of the device changes and the risk analysis method(s) 
used to assess the impact of the change(s) on the device and the 
results of the analysis. 
 
Risk control measures to mitigate identified risks (e.g., labeling, 
verification). See The Special 510(k) Program.32 
Labeling33  Submission of proposed labeling in sufficient detail to satisfy the 
requirements of 21 CFR 807.87(e). Generally, if the device is an in 
vitro diagnostic device, the labeling must also satisfy the 
requirements of 21 CFR 809.10. Additionally, the term labeling 
generally includes the device label, instructions for use, and any 
patient labeling. See Guidance on Medical Device Patient 
Labeling.34 
Reprocessing  Information for assessing the reprocessing validation and labeling, 
if applicable. See Reprocessing Medical Devices in Health Care 
Settings: Validation Methods and Labeling.35 
 
30 21 CFR 807.87(f) and FD&C Act section 513(i)(1)(A). 
31 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k. 
32 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program.  
33 21 CFR 807.87(e). 
34 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-
labeling. 
35 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling. 
9  Contains Nonbinding Recommendations 
 
Information Requested  Description 
Sterility  Information on sterility and validation methods, if applicable. See 
Submission and Review of Sterility Information in Premarket 
Notification (510(k)) Submissions for Devices Labeled as 
Sterile.36 
Shelf Life  Summary of methods used to establish that device performance is 
maintained for the entirety of the proposed shelf-life37 (e.g., 
mechanical properties, coating integrity, pH, osmolality), if 
applicable.  
Biocompatibility  Information on the biocompatibility assessment of patient 
contacting materials, if applicable. See Use of International 
Standard ISO 10993-1, Biological evaluation of medical devices - 
Part 1: Evaluation and testing within a risk management 
process.38 
Software/Firmware  Submission of applicable software documentation, if applicable. 
See Guidance for the Content of Premarket Submissions for 
Software Contained in Medical Devices.39 
Cybersecurity/Interoperability  Submission of applicable information regarding the assessment of 
cybersecurity, if applicable. See Content for Premarket 
Submissions for Management of Cybersecurity in Medical 
Devices40 and Design Considerations and Premarket Submission 
Recommendations for Interoperable Medical Devices.41 
Electromagnetic  Submission of the EMC, Electrical, Mechanical, Wireless and 
Compatibility (EMC),  Thermal Safety testing for your device or summarize why testing 
Electrical, Mechanical,  is not needed. See Electromagnetic Compatibility (EMC) of 
Wireless and Thermal Safety  Medical Devices42 and Radio Frequency Wireless Technology in 
Medical Devices.43 
 
36 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled. 
37 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-life-medical-devices. 
38 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and. 
39 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-
submissions-software-contained-medical-devices. 
40 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-
management-cybersecurity-medical-devices-0. 
41 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-and-pre-
market-submission-recommendations-interoperable-medical-devices. 
42 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-support-claim-
electromagnetic-compatibility-emc-electrically-powered-medical-devices. 
43 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radio-frequency-wireless-
technology-medical-devices-guidance-industry-and-fda-staff. 
10  Contains Nonbinding Recommendations 
 
Information Requested  Description 
Performance Testing   For non-in vitro diagnostic devices: Provide information on the 
non-clinical and clinical test reports submitted, referenced, or 
relied on in the 510(k) for a determination of substantial 
equivalence. See Recommended Content and Format of Non-
Clinical Bench Performance Testing Information in Premarket 
Submissions.44 
 
For in vitro diagnostic devices: Provide analytical performance, 
comparison studies, reference range/expected values, and clinical 
study information. 
References  Inclusion of any literature references, if applicable. 
Administrative  Inclusion of additional administrative forms applicable to the 
Documentation  submission, including but not limited to a general summary of 
submission/executive summary (recommended), a Truthful and 
Accuracy Statement,45 and a 510(k) Summary46 or statement.47 
Amendment/Additional  Inclusion of responses to Additional Information requests.48 
Information (AI) response 
 
  Electronic Submission Template Waivers, Exemptions, 
and Timing 
All 510(k) submissions, including original submissions for Traditional, Special, and Abbreviated 
510(k)s, and subsequent Supplements and Amendments (amendments include add-to-files and 
appeals),49 and any other subsequent submissions to an original submission unless exempted 
below in Section VI.A of this guidance, are required to be submitted as electronic submissions. A 
510(k) submission that is not provided as an electronic submission as described in Section V 
above, will not be received unless an exemption from the electronic submission requirements or 
a waiver with respect to that submission applies.  
 
A.  Waivers and Exemptions From Electronic Submission 
Requirements 
 
44 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-
non-clinical-bench-performance-testing-information-premarket. 
45 21 CFR 807.87(l). 
46 21 CFR 807.92. 
47 21 CFR 807.93. 
48 While the responses to FDA additional information requests are included in this section, submitters should include 
the actual changes to the information to be reviewed by FDA in the respective section of eSTAR (e.g., updated draft 
labeling should be included in the Labeling section). 
49 References to supplements and amendments are generally meant to capture the various submission types that 
typically occur in association with a 510(k) file that is undergoing review or has received a final decision.  
11  Contains Nonbinding Recommendations 
 
Above, FDA identified that 510(k) submissions are subject to electronic submission 
requirements. However, section 745A(b)(2) of the FD&C Act allows for FDA to set forth criteria 
for exemptions and waivers from electronic submission requirements. FDA has identified such 
criteria for 510(k)s below. 
 
Exemptions 
At this time, FDA is exempting the following 510(k) submissions/information from the 510(k) 
electronic submission requirements:  
  Interactive review responses;50 
  Amendments:51 
  Appeals/requests for supervisory review;52 
  Substantive summary requests; 
  Change in correspondent amendments; 
  Amendments after final decision (i.e., add-to-files); and 
  Withdrawal requests.53 
 
Waivers 
At this time, FDA has not identified any particular circumstances appropriate for a waiver of the 
510(k) electronic submission requirements and does not intend to grant requests for waiver. 
Given the widespread availability of software to enable use of the current 510(k) eSTAR PDF 
(available to download on FDAs website), all submitters should have the ability to provide a 
510(k) eSTAR.54  
 
B.  When Electronic Submissions Will Be Required  
As described in the 745A(b) device parent guidance, this guidance specifies the corresponding 
timetable(s) for implementation of 510(k) electronic submissions. FDA is identifying October 1, 
2023 as the date on which the 510(k) electronic submission requirements will take effect. This 
 
50 If the reviewer used interactive review via phone or email, the submitter should reply to the reviewer via email 
with the requested attachments and additional information. Other responses to requests for additional information 
must be submitted in eSTAR (see Amendment/Additional Information (AI) Response category in Table 1 above). 
51 These 510(k) amendments remain subject to any applicable eCopy requirements. For more information, see the 
FDA guidance eCopy Program for Medical Device Submissions at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/ecopy-program-medical-device-submissions. 
52 Section 745A(b)(3) of the FD&C Act authorizes FDA to also require that appeals be submitted solely in such 
electronic format as specified by the Agency in guidance. Once FDA develops such a format, FDA intends to update 
this guidance to specify any further standards for the submission of 510(k) appeals by electronic format, the 
timetable for establishment of such further standards, and any criteria for a waiver from such requirements. 
53 As 510(k) supplements, submission withdrawal requests remain subject to any applicable eCopy requirements. 
For more information, see the FDA guidance eCopy Program for Medical Device Submissions at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions. FDA recommends that withdrawal requests be submitted electronically via email or to the CDRH 
Portal. 
54 While use of the eSTAR will be required starting on October 1, 2023, there are currently known technical reasons 
that preclude electronic submission via the CDRH Portal and impacted submissions will need to be mailed to the 
CDRH Document Control Center (DCC). For a list of the known technical reasons, please refer to FDAs CDRH 
Portal webpage, available at https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-
medical-device-premarket-submissions-online-cdrh-portal 
12  Contains Nonbinding Recommendations 
 
date includes a transition period of a minimum of one year prior to the requirement that all 
510(k) submissions be provided as electronic submissions. During the transition period, eSTARs 
may be used voluntarily for 510(k) submissions. At this time, eSTAR is the only electronic 
submission template available to prepare a complete 510(k) electronic submission using the 
guided prompts for the collection of structured and unstructured data. As instructed at the 
website for the eSTAR Program (under the heading, How to prepare a submission using 
eSTAR55), the electronic submission must be submitted using FDAs electronic portal when 
submitted to CDRH, or via FDAs Electronic Submission Gateway56 when submitted to CBER. 
FDA only intends to accept 510(k) submissions saved to a form of electronic storage media and 
mailed to FDA if they are received by FDA before October 1, 2023. 
 
   
 
55 https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program#prepare. 
56 https://www.fda.gov/industry/electronic-submissions-gateway. 
13