Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Electronic Submission Template for Investigational Device Exemption (IDE) Applications." FDA is issuing this draft guidance for sponsors submitting IDE applications to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those sponsors to the current publicly available resources and associated content developed to support IDE electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as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 sponsors to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.

Full Text

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<title>Federal Register, Volume 91 Issue 207 (Wednesday, October 28, 2026)</title>
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[Federal Register Volume 91, Number 207 (Wednesday, October 28, 2026)]
[Notices]
[Pages 67840-67842]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21953]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-D-11188]


Electronic Submission Template for Investigational Device 
Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and 
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance titled ``Electronic Submission 
Template for Investigational Device Exemption (IDE) Applications.'' FDA 
is issuing this draft guidance for sponsors submitting IDE applications 
to the Center for Devices and Radiological Health (CDRH) and Center for 
Biologics Evaluation and Research (CBER). It introduces those sponsors 
to the current publicly available resources and associated content 
developed to support IDE electronic submissions to FDA. This draft 
guidance, when finalized, 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 sponsors 
to improve submission consistency and enhance efficiency in the review 
process. This draft guidance is not final nor is it for implementation 
at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by December 28, 2026 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2026-D-11188 for ``Electronic

[[Page 67841]]

Submission Template for Investigational Device Exemption (IDE) 
Applications.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document titled 
``Electronic Submission Template for Investigational Device Exemption 
(IDE) Applications'' to the Office of Policy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and 
Radiological Health, Food and Drug Administration, 301-796-6353; or 
Phillip Kurs, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this draft guidance document to introduce sponsors 
submitting IDE applications to CDRH and CBER to the current resources 
and associated content developed and made publicly available to support 
the electronic submissions of Original IDE applications, IDE 
supplemental applications, and amendments to Original IDE and IDE 
supplemental applications, and related IDE submissions to FDA. This 
draft 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 sponsors to improve 
submission consistency and enhance efficiency in the review process. 
When finalized, this guidance will also facilitate the implementation 
of the FDA's mandate under section 745A(b) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(b)), amended by section 
207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52), 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 final guidance document published on July 15, 2020 (85 FR 
42864): ``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 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. When finalized, this 
guidance will provide such information for IDE electronic submissions 
solely in electronic format.
    In section 745A(b) of the FD&C Act, Congress granted explicit 
statutory authorization to FDA to specify in guidance the statutory 
requirement for electronic submissions solely in electronic format by 
providing standards, a timetable, and criteria for waivers and 
exemptions. To the extent that this draft guidance provides such 
requirements under section 745A(b)(3) of the FD&C Act (i.e., standards, 
timetable, criteria for waivers of and exemptions), indicated by the 
use of the mandatory words, such as must or required, this document is 
not subject to the usual restrictions in FDA's good guidance practice 
regulations, such as the requirement that guidances not establish 
legally enforceable responsibilities (see Sec.  10.115(d)). To the 
extent that this draft guidance describes recommendations that are not 
standards, timetable, criteria for waivers of, or exemptions under 
section 745A(b)(3) of the FD&C Act, it is being issued consistent with 
FDA's good guidance practices regulation (Sec.  10.115).
    The draft guidance, when finalized, will represent the current 
thinking of FDA on Electronic Submission Template for IDE Applications. 
With the exception of the guidance's provision of requirements for 
``standards,'' ``timetable,'' or ``criteria for waivers'' and 
``exemptions'' pursuant to section 745A(b) of the Federal Food, Drug, 
and Cosmetic Act, 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.
    As we develop final guidance on this topic, FDA will consider 
comments on costs or cost savings the guidance may generate, relevant 
for Executive Order 14192.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also 
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, https://

[[Page 67842]]

www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
<a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. Persons unable to download an 
electronic copy of ``Electronic Submission Template for Investigational 
Device Exemption (IDE) Applications'' may send an email request to 
<a href="/cdn-cgi/l/email-protection#abe8eff9e386ecdec2cfcac5c8ceebcdcfca85c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="632027312b4e24160a07020d0006230507024d0b0b104d040c15">[email&#160;protected]</span></a> to receive an electronic copy of the 
document. Please use the document number GUI00007080 and complete title 
to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in the following table have been approved by OMB:

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                                                            OMB control
            21 CFR part                     Topic               No.
------------------------------------------------------------------------
812...............................  Investigational            0910-0078
                                     Device Exemption.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality Management
                                     System Regulation
                                     (QMSR).
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21953 Filed 10-27-26; 8:45 am]
BILLING CODE 4164-01-P


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