Withdrawal of de novo request

Contains Nonbinding Recommendations

Electronic Submission Template for
Medical Device De Novo Requests
Guidance for Industry and
Food and Drug Administration Staff
Document issued on August 23, 2024.
The draft of this document was issued on September 29, 2023
For questions about this document regarding CDRH-regulated devices, contact ORP: Office of
Regulatory Programs at 301-796-5640 or [email protected]. 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
[email protected].

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

OMB Control No. 0910-0844
Current expiration date available at https://www.reginfo.gov.
See additional PRA statement in Section VII of this guidance.

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 208521740. Identify all comments with the docket number FDA-2023-D-3788. 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 [email protected] 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 240-4028010, by email, [email protected], or from the Internet at https://www.fda.gov/vaccines-bloodbiologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

Contains Nonbinding Recommendations

Table of Contents

I.

Introduction ..............................................................................................................................1

II.

Background ..............................................................................................................................2

III.

Scope .....................................................................................................................................3

IV.

Significant Terminology........................................................................................................4

V.

Current Electronic Submission Template Structure, Format, and Use.....................................5
A.

VI.
A.

Structure of the Current De Novo Electronic Submission Template.................................6
Electronic Submission Template Waivers, Exemptions, and Timing .................................11
Waivers and Exemptions From Electronic Submission Requirements............................11

B.
When Electronic Submissions Will Be Required ............................................................12
VII. Paperwork Reduction Act of 1995…………………………………………………………………12

Contains Nonbinding Recommendations

Electronic Submission Template for
Medical Device De Novo Requests
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
or Office responsible for this guidance as listed on the title page.

I.

Introduction

The Food and Drug Administration (FDA or Agency) is issuing this guidance document to
introduce submitters of De Novo requests1 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 De Novo electronic
submissions to FDA. This guidance is intended to represent one of several steps in meeting
FDA’s 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.2 This guidance facilitates the implementation of the FDA’s
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. 115-523) 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.
FDA’s guidance document “Providing Regulatory Submissions for Medical Devices in
Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and
Cosmetic Act” (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
1

See section 513(f)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act and 21 CFR part 860, subpart D.
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, 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 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/download
3
https://www.govinfo.gov/content/pkg/PLAW-115publ52/html/PLAW-115publ52.htm
2

1

Contains Nonbinding Recommendations
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
submissions and corresponding timetables for implementation. This guidance provides such
information for De Novo 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 FDA’s 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 FDA’s 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 Agency’s 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 will have a binding
effect.
For those provisions not identified as binding, the contents of this document are not intended to
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.

II. Background
Section 745A(b) of the FD&C Act, amended by section 207 of FDARA, requires that presubmissions 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 FDA beginning on such date as
specified by FDA in final guidance. It also mandates that FDA issue draft guidance not later than
2

Contains Nonbinding Recommendations
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.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. The Medical Device User Fee Amendments of 2022 (MDUFA V)
Commitment Letter affirmed FDA’s commitment to the continued development of electronic
submission templates for a variety of premarket submission types.6
In February 2020, CDRH piloted the use of the electronic Submission Template And Resource
(eSTAR) electronic submission template for 510(k)s through launching the eSTAR Pilot
Program.7 CBER piloted the use of eSTAR for 510(k)s in June 2022.8 The eSTAR template
became available for voluntary use by all 510(k) submitters in September 2020. Mandatory use
of the eSTAR template for 510(k) submissions began in October 2023. In January 2022, CDRH
expanded the eSTAR template to include the ability to submit content for De Novo requests.
During the transition time up to the point when De Novo electronic submissions will be required
(see Section VI.B below), anyone can voluntarily use eSTAR for submission of De Novo
requests. As described below, eSTAR is the only electronic submission template currently
available to enable De Novo electronic submissions.

III. Scope
This guidance describes the technical standards associated with preparation of the electronic
submission template for De Novo classification requests9 that enable submission of the De Novo
electronic submission solely in electronic format. The electronic submission template includes
4

See section 745A(b)(3)(B) of the FD&C Act.
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
See 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
7
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
8
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-andreview-center-for-biologics-evaluation-and-research
9
See section 513(f)(2) of the FD&C Act and 21 CFR part 860, subpart D.
5

3

Contains Nonbinding Recommendations
the information and guided prompts FDA believes will best facilitate the collection and assembly
of the necessary elements of a ‘complete’ submission.10 This guidance is not intended to specify
the user-interface and detailed content of the eSTAR, but instead is limited to establishing the De
Novo 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 FDA’s website.11

IV. 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.12 An electronic copy is not considered
to be an electronic submission, as defined below.
Electronic Submission (eSubmission): The submission package produced by an electronic
submission template13 that contains the data of a ‘complete’14 submission.
eSTAR (electronic Submission Template And Resource): An electronic submission
template15 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 De Novo requests 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.16
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.

10

See 21 CFR 860.230 and the FDA guidance “Acceptance Review for De Novo Classification Requests”.
See FDA’s website on the eSTAR program at https://www.fda.gov/medical-devices/how-study-and-market-yourdevice/voluntary-estar-program
12
See 84 FR 68334 and the FDA guidance “eCopy Program for Medical Device Submissions”.
13
See 84 FR 68334 and the FDA guidance “eCopy Program for Medical Device Submissions”.
14
See 21 CFR 860.230 and the FDA guidance “Acceptance Review for De Novo Classification Requests”.
15
The De Novo eSTAR can be downloaded for free on FDA’s website at https://www.fda.gov/medicaldevices/how-study-and-market-your-device/voluntary-estar-program
16
https://www.fda.gov/media/102699/download
11

4

Contains Nonbinding Recommendations

V. 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 De Novo 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’ De Novo17 request. eSTAR is highly
automated, includes integrated databases (e.g., FDA product codes, FDA-recognized voluntary
consensus standards), 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 submitter’s reference. Finally, eSTAR is structured to
collect and assemble content in the De Novo request as an electronic submission that closely
follows the content of the “SMART” De Novo review memo template used by FDA reviewers.
Given that an electronic submission properly prepared with an electronic submission template
should represent a complete submission,18 the acceptance review under 21 CFR 860.230 has
been largely automated within the eSTAR.19 However, FDA intends to employ a virus scanning
and technical screening process for an eSTAR as part of the acceptance review process. A
technical screening process is a process for verifying that eSTAR responses are consistent with
descriptions of 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).
A completed eSTAR submission and the use of the technical screening process incorporates the
acceptance review criteria described in 21 CFR 860.230(c)(1)(i) through (v). As part of
considering these criteria, FDA staff should determine whether the subject device is a device
type for which De Novo classification is known to be an inappropriate regulatory approach. If
the device does not appear to be eligible for De Novo classification (e.g., a predicate device
exists, an existing classification regulation exists for the same device type, or an approved
PMA(s) exists for the same device type), FDA staff should make this determination during the
technical screening process. The technical screening process is not intended to identify De Novo
requests for which a substantive review is required in order to determine if De Novo
classification is an inappropriate approach (e.g., FDA staff need to conduct a substantive review
of information in the request to research and analyze De Novo eligibility or to determine if
special controls can mitigate the identified risks to health). If FDA determines the device is
ineligible during the technical screening process, FDA considers this to be a basis for placing the
De Novo request on hold (see section 513(f)(2) of the FD&C Act, 21 CFR 860.200, 21 CFR
860.230(c)(1)(ii), and 83 FR 63128).

17

See 21 CFR 860.230 and the FDA guidance “Acceptance Review for De Novo Classification Requests”.
After submitters complete 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.
19
For more information on the acceptance process, please see 21 CFR 860.230 and the FDA guidance “Acceptance
Review for De Novo Classification Requests”.
18

5

Contains Nonbinding Recommendations
Additionally, in evaluating the criterion described in 21 CFR 860.230(c)(1)(iv) FDA staff should
also consider if the De Novo request is for devices of more than one type. It may be appropriate
for FDA to review multiple devices in a single marketing submission under certain
circumstances.20 For example, it may be appropriate for multiple sizes of a device to be reviewed
together in a De Novo request and classified together as the same type of device under a single
regulation. However, if a De Novo requester is instead proposing that multiple device types be
classified under a single De Novo request (e.g., a submission for a device with multiple proposed
indications or technologies that each have different benefit-risk considerations and supporting
datasets would likely constitute more than one device type), the De Novo request should be
placed on hold (see 21 CFR 860.230(c)(1)(iv)) and the review team should work with the De
Novo requester to clarify which device type should be the subject of the De Novo request. This
helps ensure efficient use of FDA resources by confining the scientific and regulatory issues in a
submission to a single classification decision so that FDA can render a timely decision and
assess user fees appropriately.
The technical screening process should occur within 15 calendar days of FDA receiving the De
Novo eSTAR.21 FDA will only begin the technical screening for De Novo electronic submissions
where the appropriate user fee has been paid. If the eSTAR is not complete when submitted,
FDA will notify the submitter via email22 and identify the incomplete information, and the De
Novo will be placed on hold. If a replacement eSTAR is not received within 180 days of the date
of technical screening deficiency notification, FDA will consider the De Novo to be withdrawn
and the submission will be closed in the system.23 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.
Once the eSTAR passes technical screening and the De Novo submission is accepted, FDA will
notify the requester electronically.24 If FDA does not complete the technical screening within the
acceptance review period (i.e., within 15 calendar days of receipt), FDA will accept the De Novo
request for review and will notify the requester.25

A.

Structure of the Current De Novo Electronic Submission
Template

20

See also FDA’s guidance entitled “Bundling Multiple Devices or Multiple Indications in a Single Submission”.
21 CFR 860.230(a).
22
For additional information about email communications with CBER, please see the “SOPP 8119: Use of Email for
Regulatory Communications”.
23
See 21 CFR 860.250(a)(2).
24
21 CFR 860.230(a). For additional information about email communications with CBER, please see “SOPP 8119:
Use of Email for Regulatory Communications”.
25
21 CFR 860.230(b).
21

6

Contains Nonbinding Recommendations
In Table 1 below, is a high-level overview of the structure of the current electronic submission
template for De Novos,26 including a summary of the anticipated submission content provided by
the submitter in each section:27
Table 1: Structure of the current eSTAR De Novo Electronic Submission Template
Information Requested
Submission Type

Description
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.28

Cover Letter / Letters of
Reference

Attach a cover letter and any documents that refer to other
submissions.

Applicant29 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
Correspondence & Previous
Regulator Interaction

Information on prior or ongoing submissions for the same device
included in the current submission, such as submission numbers
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 Standards30

Identification of voluntary consensus standard(s) used, if
applicable. This includes both FDA-recognized and nonrecognized consensus standards (see 21 CFR 860.220(a)(12)).

26

As indicated above, FDA intends to employ a technical screening process to verify that electronic submission
template responses accurately describe the device.
27
Throughout completion of the eSTAR, submitters can add attachments as unstructured data, including documents,
PDFs, images, and videos that submitters believe 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.
28
https://www.fda.gov/media/72421/download
29
As 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.
30
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-andconformity-assessment-program

7

Contains Nonbinding Recommendations
Information Requested
Device Description

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 overthe-counter.”

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)).
8

Contains Nonbinding Recommendations
Information Requested
Benefits, Risks, and Mitigation
Measures

Description
A summary of the probable risks to health associated with use of
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 FDA guidance “Factors to Consider When
Making Benefit-Risk Determinations in Medical Device
Premarket Approval and De Novo Classifications”).

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 FDA guidance “Guidance on Medical Device
Patient Labeling”).

Reprocessing*

Information for assessing the reprocessing validation and
labeling, if applicable (see FDA guidance “Reprocessing
Medical Devices in Health Care Settings: Validation Methods
and Labeling”).

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 FDA guidance “Shelf Life of Medical Devices”).

Biocompatibility*

Information on the biocompatibility assessment of patient
contacting materials, if applicable (see FDA guidance “Use of
International Standard ISO 10993-1, ‘Biological evaluation of
medical devices - Part 1: Evaluation and testing within a risk
management process’”).
9

Contains Nonbinding Recommendations
Information Requested
Software/Firmware

Description
Submission of applicable software documentation, if applicable
(see 21 CFR 860.220(a)(15)(ii) and FDA guidance “Guidance
for the Content of Premarket Submissions for Software
Contained in Medical Devices”).

Cybersecurity/Interoperability*

Submission of applicable information regarding the assessment
of cybersecurity, if applicable (see FDA guidance “Content for
Premarket Submissions for Management of Cybersecurity in
Medical Devices” and “Design Considerations and Premarket
Submission Recommendations for Interoperable Medical
Devices”).

Electromagnetic Compatibility
(EMC), Electrical, Mechanical,
Wireless and Thermal Safety*

Submission of the EMC, Electrical, Mechanical, Wireless and
Thermal Safety testing for your device or summarize why testing
is not needed (see FDA guidance “Electromagnetic
Compatibility (EMC) of Medical Devices” and “Radio
Frequency Wireless Technology in Medical Devices”).

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 FDA
guidance “Recommended Content and Format of Non-Clinical
Bench Performance Testing Information in Premarket
Submissions”).
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
Information (AI) response

Inclusion of responses to Additional Information requests.31

31

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).

10

Contains Nonbinding Recommendations
* The information in eSTAR for these sections is intended to fulfill the requirements of 21 CFR
860.220(a)(13) and 21 CFR 860.220(a)(15)(i).
^ The information in eSTAR for this section is intended to fulfill the requirements of 21 CFR
860.220(a)(15)(iii).

VI. Electronic Submission Template Waivers, Exemptions,
and Timing
With this final guidance, all submissions for De Novo requests, including original, Supplements
and Amendments (amendments include add-to-files and appeals),32 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 as of the implementation date. A De Novo
request that is not provided as an electronic submission as of that date and 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

Above, FDA identified that De Novo requests are subject to electronic submission requirements
of this final guidance after the implementation date. 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 De Novos below.
Exemptions
FDA is exempting the following De Novo submissions/information from the De Novo electronic
submission requirements:
x Interactive review responses;33
x Amendments:34
x Appeals/requests for supervisory review;35
x Substantive summary requests;
x Change in correspondent amendments;
x Amendments after final decision (i.e., add-to-files); and

32

References 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.
33
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).
34
These De Novo amendments remain subject to any applicable eCopy requirements. For more information, see the
FDA guidance “eCopy Program for Medical Device Submissions”.
35
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 De Novo appeals by electronic format, the
timetable for establishment of such further standards, and any criteria for a waiver from such requirements.

11

Contains Nonbinding Recommendations
x

Withdrawal requests.36

Waivers
At this time, FDA has not identified any particular circumstances appropriate for a waiver of the
De Novo electronic submission requirements and does not intend to grant requests for waiver.
Given the widespread availability of software to enable use of the current De Novo eSTAR PDF
(available to download on FDA’s website), all submitters should have the ability to provide a De
Novo eSTAR.37

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 De Novo electronic submissions. FDA is identifying October
1, 2025, as the date on which the De Novo electronic submission requirements will take effect.
This date includes a transition period of a minimum of one year prior to the requirement that all
De Novo submissions be provided as electronic submissions. During the transition period,
eSTARs may be used voluntarily for submission of De Novo requests. As instructed at the
website for the eSTAR Program (under the heading, “How to prepare a submission using
eSTAR”38), the electronic submission must be submitted using FDA’s electronic portal when
submitted to CDRH. You can submit questions pertaining to the preparation of submission in
electronic format to CDRH at [email protected]. For electronic
submissions to CBER, please refer to Regulatory Submissions in Electronic Format for CBERRegulated Products on how to submit through the Electronic Submissions Gateway. You can
submit questions pertaining to the preparation of submission in electronic format to CBER
at [email protected].

VII. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The time required to complete this information collection is estimated to be 182 hours. This includes the time
to review instructions, search existing data sources, gather the data needed, and complete and review the
information collection. Send comments regarding this burden estimate or suggestions for reducing this burden
to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. The OMB control number for this
information collection is 0910-0844 (To find the current expiration date, search for this OMB control
number available at https://www.reginfo.gov).

12

Contains Nonbinding Recommendations

36

Submission withdrawal requests remain subject to any applicable eCopy requirements.
For more information, see the FDA guidance “eCopy Program for Medical Device Submissions.” FDA recommends
that withdrawal requests be submitted electronically via email or to the CDRH Portal.
37
There 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 FDA’s CDRH Portal webpage, available at
https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarketsubmissions-online-cdrh-portal
38
https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program

13