[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Pages 61600-61602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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DATES: Submit either electronic or written comments on the draft 
guidance by December 6, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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: 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.
    <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 https://www.regulations.gov 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 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 
``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 https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health.
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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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k.
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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 https://wayback.archive-it.org/7993/20190206202131/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm604500.htm. 
Public comments submitted can be searched under the docket FDA-2018-
N-4751, available at https://www.regulations.gov/docket/FDA-2018-N-4751.
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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 
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 
``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:

------------------------------------------------------------------------
 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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