Notice2023-19283
Modernizing the Food and Drug Administration's Premarket Notification Program; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
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Published
September 7, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidances entitled "Evidentiary Expectations for 510(k) Implant Devices," "Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions," and "Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission." FDA is issuing these guidances to improve the predictability, consistency, and transparency of the 510(k) premarket review process. The draft guidances are not final nor are they for implementation at this time.
Full Text
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<title>Federal Register, Volume 88 Issue 172 (Thursday, September 7, 2023)</title>
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[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Pages 61600-61602]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19283]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2023-D-3132, FDA-2023-D-3133, and FDA-2023-D-3134]
Modernizing the Food and Drug Administration's Premarket
Notification Program; Draft Guidances 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 three draft guidances entitled ``Evidentiary
Expectations for 510(k) Implant Devices,'' ``Recommendations for the
Use of Clinical Data in Premarket Notification [510(k)] Submissions,''
and ``Best Practices for Selecting a Predicate Device to Support a
Premarket Notification [510(k)] Submission.'' FDA is issuing these
guidances to improve the predictability, consistency, and transparency
of the 510(k) premarket review process. The draft guidances are not
final nor are they for implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by December 6, 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:
<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 Docket No. FDA-
2023-D-3132 for ``Evidentiary Expectations for 510(k) Implant
Devices,'' Docket No. FDA-2023-D-3133 for ``Recommendations for the Use
of Clinical Data in Premarket Notification [510(k)] Submissions,'' or
Docket No. FDA-2023-D-3134 for ``Best Practices for Selecting a
Predicate Device to Support a Premarket Notification [510(k)]
Submission.'' 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
[[Page 61601]]
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 entitled
``Evidentiary Expectations for 510(k) Implant Devices,''
``Recommendations for the Use of Clinical Data in Premarket
Notification [510(k)] Submissions,'' or ``Best Practices for Selecting
a Predicate Device to Support a Premarket Notification [510(k)]
Submission'' 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: Angela DeMarco, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2436, Silver Spring, MD 20993-0002, 301-796-4471;
or Anne Taylor, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7242,
Silver Spring, MD 20993, 240-402-8113.
SUPPLEMENTARY INFORMATION:
I. Background
As part of FDA's Medical Device Safety Action Plan: Protecting
Patients, Promoting Public Health,\1\ FDA committed to strengthen and
modernize the premarket notification (510(k)) Program. FDA is issuing
these three draft guidances to enhance the transparency, consistency,
and predictability of the 510(k) premarket review process.
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\1\ Available at <a href="https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health">https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health</a>.
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In ``Evidentiary Expectations for 510(k) Implant Devices,'' FDA
discusses considerations that are generally relevant to all types of
implants subject to 510(k) requirements. This draft guidance is
intended to serve as a primary resource, used in conjunction with other
guidances, to provide clarity and facilitate discussions regarding
expectations for performance data that may be necessary to establish
substantial equivalence for implanted medical devices. However, the
type and quantity of performance data needed to support a substantial
equivalence determination for a particular device will vary depending
on the device and/or device type and on the differences from the
predicate device.
In ``Recommendations for the Use of Clinical Data in Premarket
Notification [510(k)] Submissions,'' FDA clarifies and provides
additional context for situations when clinical data may be necessary
to demonstrate substantial equivalence, as initially described in the
final guidance ``The 510(k) Program: Evaluating Substantial Equivalence
in Premarket Notifications [510(k)]'' \2\ (``510(k) Program
Guidance''). This draft guidance expands on the scenarios described in
the 510(k) Program Guidance, describes another scenario, and provides
additional examples to illustrate when clinical data may or may not be
necessary to include in a 510(k) submission to demonstrate substantial
equivalence.
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\2\ Available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k</a>.
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Finally, in ``Best Practices for Selecting a Predicate Device to
Support a Premarket Notification [510(k)] Submission,'' FDA proposes
four best practices for choosing a predicate device used to support a
510(k) submission. Initially, FDA considered making public on its
website those cleared devices that demonstrated substantial equivalence
to older predicate devices. FDA also considered focusing on predicates
that were more than 10 years old as a starting point. FDA issued a
public notice on its website that requested public comment on this
proposal.\3\ After considering the docket comments, FDA believes use of
best practices that encourage the use of predicate devices with certain
characteristics, rather than focusing on the age of the predicate, will
support modernization of the 510(k) Program with respect to the use of
predicate devices and encourage the evolution of safer and more
effective medical devices.
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\3\ Available at <a href="https://wayback.archive-it.org/7993/20190206202131/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm604500.htm">https://wayback.archive-it.org/7993/20190206202131/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm604500.htm</a>.
Public comments submitted can be searched under the docket FDA-2018-
N-4751, available at <a href="https://www.regulations.gov/docket/FDA-2018-N-4751">https://www.regulations.gov/docket/FDA-2018-N-4751</a>.
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These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidances,
when finalized, will represent the current thinking of FDA on the
topics discussed in ``Evidentiary Expectations for 510(k) Implant
Devices,'' ``Recommendations for the Use of Clinical Data in Premarket
Notification [510(k)] Submissions,'' and ``Best Practices for Selecting
a Predicate Device to Support a Premarket Notification [510(k)]
Submission.'' These draft guidances do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Electronic Access
Persons interested in obtaining copies of these draft guidances may
do so by downloading electronic copies 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-
[[Page 61602]]
regulatory-assistance/guidance-documents-medical-devices-and-radiation-
emitting-products. These guidance documents are 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
``Evidentiary Expectations for 510(k) Implant Devices'' (document
number GUI00020017), ``Recommendations for the Use of Clinical Data in
Premarket Notification [510(k)] Submissions'' (document number
GUI00020016), or ``Best Practices for Selecting a Predicate Device to
Support a Premarket Notification [510(k)] Submission'' (document number
GUI00020006) may send an email request to <a href="/cdn-cgi/l/email-protection#145750465c3953617d70757a7771547270753a7c7c673a737b62"><span class="__cf_email__" data-cfemail="7a393e2832573d0f131e1b14191f3a1c1e1b54121209541d150c">[email protected]</span></a> to
receive an electronic copy of the document. Please use the document
number and complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While these guidances contain no new collection of information,
they do 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 OMB control
form Topic No.
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807, subpart E................. Premarket notification. 0910-0120
``Requests for Feedback and Q-Submissions and Early 0910-0756
Meetings for Medical Device Payor Feedback Request
Submissions: The Q-Submission Programs for Medical
Program''. Devices.
800, 801, 809, and 830......... Medical Device Labeling 0910-0485
Regulations; Unique
Device Identification.
803............................ Medical Devices; 0910-0437
Medical Device
Reporting;
Manufacturer
reporting, importer
reporting, user
facility reporting,
distributor reporting.
810............................ Medical Device Recalls. 0910-0432
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
822............................ Postmarket Surveillance 0910-0449
of Medical Devices.
Forms FDA 3500 and FDA 3500A... Medical device adverse 0910-0291
event reporting--
MedWatch.
58............................. Good Laboratory 0910-0119
Practice (GLP)
Regulations for
Nonclinical Laboratory
Studies.
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Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19283 Filed 9-6-23; 8:45 am]
BILLING CODE 4164-01-P
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