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[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67309-67311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21405]

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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Requests; Draft Guidance for Industry and Food and Drug Administration 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the availability of the draft guidance entitled ``Electronic Submission 
Template for Medical Device De Novo Requests.'' FDA is issuing this 
draft guidance to introduce submitters of De Novo requests to the 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

[[Page 67310]]

to support De Novo 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 This draft guidance, 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 guidance submission preparation tools for 
industry 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 This draft guidance is not final nor is it for 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DATES: Submit either electronic or written comments on the draft 
guidance by November 28, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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 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 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 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: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527 or 
Anne Taylor, 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 draft 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 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 industry to improve submission 
consistency and enhance efficiency in the review process.\2\ 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 \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 FD&C Act (21 U.S.C. 360c(f)(2)) 
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/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.

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[[Page 67311]]

    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. When 
finalized, 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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    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) (21 CFR 
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 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. This draft guidance, when finalized, will 
contain both binding and nonbinding provisions.

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 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                   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: September 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21405 Filed 9-28-23; 8:45 am]
BILLING CODE 4164-01-P
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