Notice2024-18983
Electronic Submission Template for Medical Device De Novo Requests; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
August 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 164 (Friday, August 23, 2024)</title>
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[Federal Register Volume 89, Number 164 (Friday, August 23, 2024)]
[Notices]
[Pages 68166-68168]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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
[[Page 68167]]
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-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 <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 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 <a href="https://www.fda.gov/media/102699/download">https://www.fda.gov/media/102699/download</a>, and 168
CONG. REC. S5194-S5203 (daily ed. September 28, 2022) (Food and Drug
Administration User Fee Reauthorization), also available at <a href="https://www.fda.gov/media/158308/downloadand">https://www.fda.gov/media/158308/downloadand</a> 168 CONG. REC. S5194-S5203
(daily ed. September 28, 2022) (Food and Drug Administration User
Fee Reauthorization), also available at <a href="https://www.fda.gov/media/158308/download">https://www.fda.gov/media/158308/download</a>.
\3\ <a href="https://www.govinfo.gov/content/pkg/PLAW-115publ52/html/PLAW-115publ52.htm">https://www.govinfo.gov/content/pkg/PLAW-115publ52/html/PLAW-115publ52.htm</a>.
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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\ <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab</a>.
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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
[[Page 68168]]
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 <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>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> 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 Medical Device De Novo Requests''
may send an email request to <a href="/cdn-cgi/l/email-protection#a7e4e3f5ef8ae0d2cec3c6c9c4c2e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="246760766c0963514d40454a4741644240450a4c4c570a434b52">[email protected]</span></a> 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
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