[Federal Register Volume 89, Number 164 (Friday, August 23, 2024)]
[Notices]
[Pages 68166-68168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18983]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-3788]


Electronic Submission Template for Medical Device De Novo 
Requests; Guidance for Industry 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 a final guidance entitled ``Electronic Submission 
Template for Medical Device De Novo Requests.'' FDA is issuing this 
guidance to introduce submitters of De Novo requests 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.

DATES: The announcement of the guidance is published in the Federal 
Register on August 23, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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

[[Page 68167]]

comments, that information will be posted on https://www.regulations.gov.
     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:
     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.
     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-2023-D-3788 for ``Electronic Submission Template for Medical Device 
De Novo Requests.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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 Sec.  
10.115 (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 guidance document entitled 
``Electronic Submission Template for Medical Device De Novo Requests'' 
to the Office of Policy, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Lisa Lim, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1108, Silver Spring, MD 20993-0002, 301-796-6443; 
or James Myers, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this guidance document to introduce submitters of De 
Novo requests \1\ to CDRH and 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 FDA's mandate under section 
745A(b) of the FD&C Act, amended by section 207 of the FDA 
Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52 \3\) 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.
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    \1\ See section 513(f)(2) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) Act and 21 CFR part 860, subpart D.
    \2\ 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, 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.
    \3\ https://www.govinfo.gov/content/pkg/PLAW-115publ52/html/PLAW-115publ52.htm.
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    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'' \4\ (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. This 
guidance will provide such information for De Novo electronic 
submissions solely in electronic format.
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    \4\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab.
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    A notice of availability of the draft guidance appeared in the 
Federal Register of September 29, 2023 (88 FR 67309). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including clarification of the use of technical 
screening during acceptance review and inclusion of the date when the 
use of eSTAR for De Novo Requests will become mandatory.
    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 guidance provides such

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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 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 guidance 
represents the current thinking of FDA on Electronic Submission 
Template for Medical Device De Novo Requests. 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. This guidance contains both 
binding and nonbinding provisions.

II. Electronic Access

    Persons interested in obtaining a copy of the 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Electronic Submission Template for Medical Device De Novo Requests'' 
may send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number 
GUI00021027 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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  21 CFR part; guidance; or FDA
              form                       Topic          OMB control No.
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807, subpart E..................  Premarket                    0910-0120
                                   notification.
860, subpart D..................  De Novo                      0910-0844
                                   classification
                                   process.
800, 801, and 809...............  Medical Device               0910-0485
                                   Labeling
                                   Regulations.
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    Dated: August 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18983 Filed 8-22-24; 8:45 am]
BILLING CODE 4164-01-P