Contains Nonbinding Recommendations
Draft Not for Implementation
Electronic Submission Template for 
Medical Device De Novo Requests
Draft Guidance for Industry and
Food and Drug Administration Staff
DRAFT GUIDANCE
This draft guidance document is being distributed for comment purposes 
only.
Document issued on September 29, 2023.
You should submit comments and suggestions regarding this draft document within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit electronic comments 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 20852-1740. Identify all comments with the docket 
number listed in the notice of availability that publishes in the Federal Register.
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
Draft Not for Implementation
Preface
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 
GUI00021027 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
Draft Not for Implementation
Table of Contents
I.  Introduction ............................................................................................................................. 1
II.  Background ............................................................................................................................. 3
III.  Scope .................................................................................................................................... 4
IV.  Significant Terminology ...................................................................................................... 4
V.  Current Electronic Submission Template Structure, Format, and Use ................................... 5
A.  Structure of the Current De Novo Electronic Submission Template ............................... 6
VI.  Electronic Submission Template Waivers, Exemptions, and Timing ............................... 11
A.  Waivers and Exemptions From Electronic Submission Requirements .......................... 12
B.  When Electronic Submissions Will Be Required .......................................................... 13 Contains Nonbinding Recommendations
Draft Not for Implementation
Electronic Submission Template for 
1 
Medical Device De Novo Requests
2 
3   
Draft Guidance for Industry and 
4 
Food and Drug Administration Staff 
5 
6   
7  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
8  Administration (FDA or Agency) on this topic. It does not establish any rights for any person 
9  and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 
10  requirements of the applicable statutes and regulations. To discuss an alternative approach, 
11  contact the FDA staff or Office responsible for this guidance as listed on the title page.  
12   
I.  Introduction 
13 
14  The Food and Drug Administration (FDA or Agency) is issuing this draft guidance document to 
15  introduce submitters of De Novo requests1 to the Center for Devices and Radiological Health 
16  (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and 
17  associated content developed and made publicly available to support De Novo electronic 
18  submissions to FDA. This draft guidance is intended to represent one of several steps in meeting 
19  FDAs commitment to the development of electronic submission templates to serve as guided 
20  submission preparation tools for industry to improve submission consistency and enhance 
21  efficiency in the review process.2 When finalized, this guidance will also facilitate the 
22  implementation of the FDAs mandate under section 745A(b) of the Federal Food, Drug, and 
23  Cosmetic Act (FD&C Act), amended by section 207 of the FDA Reauthorization Act of 2017 
24 (FDARA) (Pub. L. 115-523) to provide further standards for the submission by electronic format, 
25 a timetable for establishment of these further standards, and criteria for waivers of and 
26 exemptions from the requirements. 
27
28 FDAs guidance document Providing Regulatory Submissions for Medical Devices in 
29 Electronic Format Submissions Under Section 745A(b) of the Federal Food, Drug, and 
1See section 513(f)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act and 21 CFR part 860, subpart D.
2See 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, and 168 CONG. REC. S5194-
S5203 (daily ed. September 28, 2022) (Food and Drug Administration User Fee Reauthorization), also available at
https://www.fda.gov/media/158308/downloadand 168 CONG. REC. S5194-S5203 (daily ed. September 28, 2022) 
(Food and Drug Administration User Fee Reauthorization), also available at 
https://www.fda.gov/media/158308/download.
3https://www.govinfo.gov/content/pkg/PLAW-115publ52/html/PLAW-115publ52.htm.
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30  Cosmetic Act4 (hereafter referred to as the 745A(b) device parent guidance) provides a 
31  process for the development of templates to facilitate the preparation, submission, and review of 
32  regulatory submissions for medical devices solely in electronic format. As described in the 
33  745A(b) device parent guidance, FDA plans to implement the requirements of section 
34  745A(b)(3) of the FD&C Act with individual guidances specifying the formats for specific 
35  submissions and corresponding timetables for implementation. When finalized, this guidance 
36  will provide such information for De Novo electronic submissions solely in electronic format.  
37   
38  In section 745A(b)(3) of the FD&C Act, Congress granted explicit statutory authorization to 
39  FDA to specify in guidance the electronic submissions requirement by providing standards, 
40  criteria for waivers and exemptions, and a timetable for such submissions. Accordingly, to the 
41  extent that this document provides such requirements under section 745A(b)(3) of the FD&C 
42  Act, indicated by the use of mandatory words, such as must or required, this guidance is not 
43  subject to the usual restrictions in section 701(h) of the FD&C Act and FDAs good guidance 
44  practices (GGPs) regulations, such as the requirement that guidances not establish legally 
45  enforceable responsibilities. See 21 CFR 10.115(d).  
46   
47  This document provides draft guidance on FDAs interpretation of the statutory requirement for 
48  electronic submissions solely in electronic format. Therefore, to the extent that this draft 
49  guidance describes recommendations that are not standards, timetable, or criteria for 
50  waivers and exemptions under section 745A(b)(3) of the FD&C Act, this document does not 
51  create or confer any rights for or on any person and does not operate to bind FDA or the public, 
52  but does represent the Agencys current thinking on this topic, once final. You can use an 
53  alternative approach if the approach satisfies the requirements of the applicable statutes and 
54  regulations. If you want to discuss an alternative approach, contact the FDA staff listed on the 
55  title page of this guidance.  
56   
57  To comply with the GGP regulations and make sure that regulated entities and the public 
58  understand that guidance documents are nonbinding, FDA guidances ordinarily contain standard 
59  language explaining that guidances should be viewed only as recommendations unless specific 
60  regulatory or statutory requirements are cited. This draft guidance, when finalized, will contain 
61  both binding and nonbinding provisions. Insofar as this draft guidance provides standards, 
62  timetable, or criteria for waivers and exemptions pursuant to section 745A(b) of the 
63  FD&C Act, it will have a binding effect when final.  
64   
65  For those provisions not identified as binding, the contents of this document are not intended to 
66  have the force and effect of law. This document, other than the binding provisions when 
67  finalized, is intended only to provide clarity to the public regarding existing requirements under 
68  the law. FDA guidance documents, including this guidance, should be viewed only as 
69  recommendations, unless specific regulatory or statutory requirements are cited. The use of the 
70 word should in Agency guidance means that something is suggested or recommended, but not 
71 required.
4https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-
medical-devices-electronic-format-submissions-under-section-745ab
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72 
II.  Background
73 
74  Section 745A(b) of the FD&C Act, amended by section 207 of FDARA, requires that pre-
75  submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 
76  515(f), 520(g), 520(m), or 564 of the FD&C Act or section 351 of the Public Health Service Act, 
77  and any supplements to such pre-submissions or submissions, including appeals of those 
78  submissions, be submitted in electronic format specified by FDA beginning on such date as 
79  specified by FDA in final guidance. It also mandates that FDA issue draft guidance not later than 
80  October 1, 2019, and a final guidance not later than 1 year after the close of the public comment 
81  period, providing for further standards for the submission by electronic format, a timetable for 
82  establishment of these further standards, and criteria for waivers of and exemptions from the 
83  requirements.5  
84   
85  In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment 
86  Letter6 from the Secretary of Health and Human Services to Congress, FDA committed to 
87  developing electronic submission templates that will serve as guided submission preparation 
88  tools for industry to improve submission consistency and enhance efficiency in the review 
89  process and [by] FY [fiscal year] 2020, the Agency will issue a draft guidance document on 
90  the use of the electronic submission templates. In addition, the MDUFA IV Commitment Letter 
91  states that [n]o later than 12 months after the close of the public comment period, the Agency 
92  will issue a final guidance. The 745A(b) device parent guidance was intended to satisfy the final 
93  guidance documents referenced in section 745A(b)(3) of the FD&C Act and the MDUFA IV 
94  Commitment Letter. The Medical Device User Fee Amendments of 2022 (MDUFA V) 
95  Commitment Letter affirmed FDAs commitment to the continued development of electronic 
96  submission templates for a variety of premarket submission types.7  
97   
98  In February 2020, CDRH piloted the use of the electronic Submission Template And Resource 
99  (eSTAR) electronic submission template through launching the eSTAR Pilot Program.8 The 
100 eSTAR template became available for voluntary use by all 510(k) submitters in September 2020. 
101 In January 2022, CDRH expanded the eSTAR template to include the ability to submit content 
102 for De Novo requests. Subsequently, CBER began piloting the use of eSTAR for 510(k)s in June 
103 2022.9
104
5See section 745A(b)(3)(B) of the FD&C Act.
6See 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.
7See 168 CONG. REC. S5194-S5203 (daily ed. September 28, 2022) (Food and Drug Administration User Fee 
Reauthorization), also available athttps://www.fda.gov/media/158308/download.
8See 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.
9See 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.
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105  During the transition time up to the point when De Novo electronic submissions will be required 
106  (see Section VI.B below), anyone can voluntarily use eSTAR for submission of De Novo 
107  requests. As described below, eSTAR is the only electronic submission template currently 
108  available to enable De Novo electronic submissions. 
109   
III.  Scope 
110 
111  This guidance describes the technical standards associated with preparation of the electronic 
112  submission template for De Novo classification requests10 that enable submission of the De 
113  Novo electronic submission solely in electronic format. The electronic submission template 
114  includes the information and guided prompts FDA believes will best facilitate the collection and 
115  assembly of the necessary elements of a complete submission.11 This guidance is not intended 
116  to specify the user-interface and detailed content of the eSTAR, but instead is limited to 
117  establishing the De Novo electronic format and standards for complying with section 
118  745(A)(b)(3) of the FD&C Act. FDA intends to implement new versions of eSTAR as relevant 
119  policies change. FDA also has an ongoing process to collect and consider public comments and 
120  stakeholder feedback, which is described on FDAs website.12 
121    
IV.  Significant Terminology 
122 
123  For the purpose of this document the following significant terminology is described: 
124   
125 eCopy: An electronic copy is a duplicate device submission in electronic format of the 
126 previously required paper copy submission sent to FDA.13 An electronic copy is not considered 
127 to be an electronic submission, as defined below.
128
129 Electronic Submission (eSubmission): The submission package produced by an electronic 
130 submission template14 that contains the data of a complete15 submission.
131
10See section 513(f)(2) of the FD&C Act and 21 CFR part 860, subpart D.
11See 21 CFR 860.230 and the FDA guidance Acceptance Review for De Novo Classification Requests at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-
classification-requests.
12See FDAs website on the eSTAR program at https://www.fda.gov/medical-devices/how-study-and-market-your-
device/voluntary-estar-program.
13See 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.
14See 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.
15See 21 CFR 860.230 and the FDA guidance Acceptance Review for De Novo Classification Requests at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-
classification-requests.
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132  eSTAR (electronic Submission Template And Resource): An electronic submission 
133  template16 built within a structured dynamic PDF that guides a user through construction of an 
134  eSubmission. eSTAR is the only type of electronic submission template that is currently 
135  available to facilitate the preparation of De Novo requests as eSubmissions. For simplicity, the 
136  electronic submission created with this electronic submission template is often referred to as an 
137  eSTAR.  
138   
139  Electronic submission template: A guided submission preparation tool for industry. An 
140  electronic submission template walks industry through the relevant contents and components for 
141  the respective premarket submission type and device to facilitate submission preparation and 
142  enhance consistency, quality, and efficiency in the premarket review process.17  
143   
144  Structured data: Data and content that are captured in the fields, dropdown boxes, checkboxes, 
145  etc., within the electronic submission template. 
146   
147  Unstructured data: Data and content that are submitted as attachments to the electronic 
148  submission template. 
149   
V.  Current Electronic Submission Template Structure, 
150 
Format, and Use 
151
152  The electronic submission template, eSTAR, is the only currently available electronic 
153  submission template at this time to facilitate the preparation of De Novo electronic submissions. 
154  eSTAR consists of a collection of questions, text, logic, and prompts within a template that 
155  guides a user through construction of a complete De Novo18 request. eSTAR is highly 
156  automated, includes integrated databases (e.g., FDA product codes,19 FDA-recognized voluntary 
157  consensus standards20), and includes targeted questions designed to collect specific data and 
158 information from the submitter. eSTAR also includes applicable links to regulations, relevant 
159 guidances, and other resources for the submitters reference. Finally, eSTAR is structured to 
160 collect and assemble content in the De Novo request as an electronic submission that closely 
161 follows the content of the SMART De Novo review memo template used by FDAreviewers. 
162
163 Given that an electronic submission properly prepared with an electronic submission template 
164 should represent a complete submission,21 the acceptance review under21 CFR 860.230 has
16The De Novo 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.
17https://www.fda.gov/media/102699/download.
18See 21 CFR 860.230 and the FDA guidance Acceptance Review for De Novo Classification Requests at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-
classification-requests.
19https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm.
20https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
21After 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.
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165  been largely automated within the eSTAR.22 However, FDA intends to employ a virus scanning 
166  and technical screening process for an eSTAR as part of the acceptance review process. A 
167  technical screening process is a process for verifying that eSTAR responses are consistent with 
168  descriptions of the device(s) (e.g., there are, in fact, no tissue contacting components if indicated 
169  as such) and that there is at least one relevant attachment per each applicable attachment-type 
170  question (e.g., a Software Description attachment is included in response to the Software 
171  Description question if software is applicable to the submission). The technical screening process 
172  is anticipated to occur within 15 calendar days of FDA receiving the De Novo eSTAR. FDA will 
173  only begin the technical screening for De Novo electronic submissions where the appropriate 
174  user fee has been paid. If the eSTAR is not complete when submitted, FDA will notify the 
175  submitter via email23 and identify the incomplete information, and the De Novo will be placed on 
176  hold. If a replacement eSTAR is not received within 180 days of the date of technical screening 
177  deficiency notification, FDA will consider the De Novo to be withdrawn and the submission will 
178  be closed in the system.24 The technical screening review time does not impact the review clock 
179  for files that pass the technical screening. For a submission that passes technical screening, the 
180  review clock starts on the day the submission was received by FDA. Once the eSTAR passes 
181  technical screening and the De Novo submission is accepted, FDA will notify the requester 
182  electronically.25 If FDA does not complete the technical screening within the acceptance review 
183  period (i.e., within 15 calendar days of receipt), FDA will accept the De Novo request for review 
184  and will notify the requester.26   
185   
A.  Structure of the Current De Novo Electronic Submission 
186
Template
187
188
189 In Table 1below, is a high-level overview of the structure of the current electronic submission 
190 template for De Novos,27 including a summary of the anticipated submission content provided by 
191 the submitter in each section:28
192
22For more information on the acceptance process, please see 21 CFR 860.230 and the FDA guidance Acceptance 
Review for De Novo Classification Requests available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/acceptance-review-de-novo-classification-requests.
23For 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.
24See 21 CFR 860.250(a)(2).
2521 CFR 860.230(a). 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.
2621 CFR 860.230(b).
27As indicated above, FDA intends to employ a technical screening process to verify that electronic submission 
template responses accurately describe the device.
28Throughout completion of the eSTAR, submitters can add attachments as unstructured data, including 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. 
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193  Table 1: Structure of the current eSTAR De Novo 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 De Novo request, 
including content from current Form FDA 3514, Section A.29 
Cover Letter / Letters of  Attach a cover letter and any documents that refer to other 
Reference  submissions. 
Applicant30 Information  Information on applicant and correspondent, if applicable, 
consistent with content from current Form FDA 3514, Sections 
B and C (see 21 CFR 860.220(a)(2)).  
Pre-Submission  Information on prior or ongoing submissions for the same device 
Correspondence & Previous  included in the current submission, such as submission numbers 
Regulator Interaction  for a prior not 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, De Novo classification request, requests for 
information under section 513(g) of the FD&C Act, or 
applications for emergency use authorization (EUA) (see 21 
CFR 860.220(a)(3)).
Consensus Standards31 Identification of voluntary consensus standard(s) used, if 
applicable. This includes both FDA-recognized and non-
recognized consensus standards (see 21 CFR 860.220(a)(12)).
29https://www.fda.gov/media/72421/download.
30As described in the eSTAR PDF, the Applicant is also commonly referred to as the Submitter or previously 
Sponsor for 510(k)s, but is not necessarily the person who submits the 510(k). The Applicant is the proper term 
for PMAs but is referred to as the Requester for De Novos.
31https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-
conformity-assessment-program.
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Information Requested Description
Device Description Identification of listing number if listed with FDA.
Descriptive information for the device, in accordance with 21 
CFR 860.220(a)(6). 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.
A description of existing alternative practices or procedures used 
in diagnosing, treating, preventing, curing, or mitigating the 
disease or condition for which the device is intended or which 
similarly affect the structure and function of the body. 
Otherwise, provide a statement if there are no known or 
reasonably known alternative practices or procedures (see 21 
CFR 860.220(a)(7)).
Information on whether the device is intended to be marketed 
with accessories.
If a Request for Designation (RFD) number exists, provide the 
RFD number that established that the device or combination 
product being submitted was assigned to CDRH or CBER (see 
21 CFR 860.220(a)(3)). 
Proposed Indications for Use  Identification of the proposed indications for use of the device. 
The term indications for use, as defined in 21 CFR 
860.220(a)(5), is a general description of the disease or 
condition the device is intended to diagnose, treat, prevent, cure 
or mitigate, or affect the structure or function of the body, 
including a description of the patient population for which the 
device is intended. The indications for use include all the labeled 
patient uses of the device, including if it is prescription or over-
the-counter.
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Information Requested Description
Classification Identification of the proposed classification (Class I or II) that 
seems most appropriate for the subject device (see 21 CFR 
860.220(a)(11)).
Provide classification summary information, in accordance with 
21 CFR 860.220(a)(8)). 
Benefits, Risks, and Mitigation  A summary of the probable risks to health associated with use of 
Measures the device that are known or should reasonably be known to you 
and the proposed mitigations, including general controls and, if 
applicable, special controls for each risk (see 21 CFR 
860.220(a)(9)).
If the proposed classification recommendation is class II, 
proposed special controls to mitigate the risks to health 
associated with use of the device, in accordance with 21 CFR 
860.220(a)(10). 
A discussion demonstrating that, the data and information in the 
De Novo request constitute valid scientific evidence within the 
meaning of 21 CFR 860.7(c), and pursuant to 21 CFR 860.7, 
when subject to general controls or general and special controls, 
the probable benefits to health from use of the device outweigh 
any probable injury or illness from such use (see 21 CFR 
860.220(a)(14) and Factors to Consider When Making Benefit-
Risk Determinations in Medical Device Premarket Approval and 
De Novo Classifications).32
Labeling Submission of proposed labeling in sufficient detail to satisfy the 
requirements of 21 CFR 860.220(a)(18). 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 sections 201(k) and (m) of the 
FD&C Act and Guidance on Medical Device Patient 
Labeling).33
32https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-when-making-
benefit-risk-determinations-medical-device-premarket-approval-and-de.
33https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-
labeling.
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Information Requested Description
Reprocessing* Information for assessing the reprocessing validation and 
labeling, if applicable (see Reprocessing Medical Devices in 
Health Care Settings: Validation Methods and Labeling).34
Sterility* Information on sterility and validation methods, if applicable.
Shelf Life* Summary of methods used to establish that device performance 
is maintained for the entirety of the proposed shelf-life (e.g., 
mechanical properties, coating integrity, pH, osmolality), if 
applicable (see Shelf Life of Medical Devices).35
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).36
Software/Firmware Submission of applicable software documentation, if applicable 
(see 21 CFR 860.220(a)(15)(ii) and Guidance for the Content 
of Premarket Submissions for Software Contained in Medical 
Devices).37
Cybersecurity/Interoperability* Submission of applicable information regarding the assessment 
of cybersecurity, if applicable (see Content for Premarket 
Submissions for Management of Cybersecurity in Medical 
Devices38 and Design Considerations and Premarket 
Submission Recommendations for Interoperable Medical 
Devices).39
Electromagnetic Compatibility  Submission of the EMC, Electrical, Mechanical, Wireless and 
(EMC), Electrical, Mechanical,  Thermal Safety testing for your device or summarize why testing 
Wireless and Thermal Safety* is not needed (see Electromagnetic Compatibility (EMC) of 
Medical Devices40 and Radio Frequency Wireless Technology 
in Medical Devices).41
34https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling.
35https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-life-medical-devices
36https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and.
37https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-
submissions-software-contained-medical-devices.
38https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-
management-cybersecurity-medical-devices-0.
39https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-and-pre-
market-submission-recommendations-interoperable-medical-devices.
40https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-support-claim-
electromagnetic-compatibility-emc-electrically-powered-medical-devices.
41https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radio-frequency-wireless-
technology-medical-devices-guidance-industry-and-fda-staff.
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Draft Not for Implementation
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 De Novo to demonstrate that general controls or 
general and special controls are sufficient to provide a 
reasonable assurance of safety and effectiveness (see 
Recommended Content and Format of Non-Clinical Bench 
Performance Testing Information in Premarket Submissions).42
For in vitro diagnostic devices: Provide analytical performance, 
comparison studies, reference range/expected values, and 
clinical study information to demonstrate that general controls or 
general and special controls are sufficient to provide a 
reasonable assurance of safety and effectiveness.
References Inclusion of any literature references in accordance with 21 CFR 
860.220(a)(16).
Administrative Documentation Inclusion of additional administrative forms applicable to the 
submission, including but not limited to a general summary of 
submission/executive summary (recommended).
Amendment/Additional  Inclusion of responses to Additional Information requests.43
Information (AI) response
194  * The information in eSTAR for these sections is intended to fulfill the requirements of 21 CFR 
195  860.220(a)(13) and 21 CFR 860.220(a)(15)(i). 
196  ^ The information in eSTAR for this section is intended to fulfill the requirements of 21 CFR 
197  860.220(a)(15)(iii). 
198   
VI.  Electronic Submission Template Waivers, Exemptions, 
199 
and Timing 
200 
201 Upon finalization of this draft guidance, all submissions for De Novorequests, including 
202 original, Supplements and Amendments (amendments include add-to-files and appeals),44 and 
203 any other subsequent submissions to an original submission unless exempted below in Section 
42https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-
non-clinical-bench-performance-testing-information-premarket.
43While 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).
44References to supplements and amendments are generally meant to capture the various submission types that 
typically occur in association with a De Novo file that is undergoing review or has received a final decision. 
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Draft Not for Implementation
204  VI.Aof this guidance, are required to be submitted as electronic submissions as of the 
205  implementation date. A De Novo request that is not provided as an electronic submission as of 
206  that date and as described in Section V above, will not be received unless an exemption from the 
207  electronic submission requirements or a waiver with respect to that submission applies.  
208   
A.  Waivers and Exemptions From Electronic Submission 
209 
Requirements 
210 
211  Above, FDA identified that De Novo requests are subject to electronic submission requirements 
212  upon finalization of this draft guidance after the implementation date. However, section 
213  745A(b)(2) of the FD&C Act allows for FDA to set forth criteria for exemptions and waivers 
214  from electronic submission requirements. FDA has identified such criteria for De Novos below. 
215   
216  Exemptions 
217 Upon finalization of this draft guidance, FDA intends to implement exemptions for the following 
218  De Novo submissions/information from the De Novo electronic submission requirements:  
219    Interactive review responses;45 
220    Amendments:46 
221    Appeals/requests for supervisory review;47 
222    Substantive summary requests; 
223    Change in correspondent amendments; and 
224    Amendments after final decision (i.e., add-to-files). 
225   
226  Waivers 
227 At this time, FDA has not identified any particular circumstances appropriate for a waiver of the 
228 De Novo electronic submission requirements and does not intend to grant requests for waiver. 
229 Given the widespread availability of software to enable use of the current De Novo eSTAR PDF
230 (available to download on FDAs website), all submitters should have the ability to provide a De 
231 Novo eSTAR.48
232
45If 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 once this guidance is finalized and specifies an implementation date (see 
Amendment/Additional Information (AI) Response category in Table 1 above).
46These De Novo 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.
47Section 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 De Novo appeals by electronic format, the 
timetable for establishment of such further standards, and any criteria for a waiver from such requirements.
48There are currently known technical reasons that preclude certain electronic submissions via the CDRH Portal. 
Those impacted submissions should be mailed to the CDRH Document Control Center (DCC). For more 
information on 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.
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B. When Electronic Submissions Will Be Required  
233
234  As described in the 745A(b) device parent guidance, this draft guidance, once finalized, will be 
235  used to specify the corresponding timetable(s) for implementation of De Novo electronic 
236  submissions. By September 30, 2025, FDA intends to identify a specific date on which we will 
237  require that De Novo requests be provided as electronic submissions. We anticipate that from the 
238  time we announce a date, there will be a transition period prior to requiring that all De Novo 
239  requests be provided as electronic submissions. Currently, and during the transition period, 
240  eSTARs may be used voluntarily for submission of De Novo requests. As instructed at the 
241  website for the eSTAR Program (under the heading, How to prepare a submission using 
242  eSTAR49), the electronic submission must be submitted using FDAs electronic portal when 
243  submitted to CDRH.You can submit questions pertaining to the preparation of submission in 
244  electronic format to CDRH at OPEQSubmissionSupport@fda.hhs.gov. For electronic 
245  submissions to CBER, please refer to Regulatory Submissions in Electronic Format for CBER-
246  Regulated Products50 on how to submit through the Electronic Submissions Gateway.51 You can 
247 submit questions pertaining to the preparation of submission in electronic format to CBER 
248 at ESUBPREP@fda.hhs.gov. When a date is identified, this draft guidance will be updated and 
249 finalized to provide that specific date and set forth the electronic format(s) specified in this 
250 guidance that must be used for submission of De Novo requests. 
49https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program.
50https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/regulatory-submissions-
electronic-format-cber-regulated-products.
51https://www.fda.gov/industry/electronic-submissions-gateway.
13