[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63589-63591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20029]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4060]


Medical Devices With Indications Associated With Weight Loss 
Guidances; 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 two draft guidances entitled ``Medical Devices with 
Indications Associated with Weight Loss--Clinical Study and Benefit-
Risk Considerations'' and ``Medical Devices with Indications Associated 
with Weight Loss--Non-Clinical Recommendations.'' These draft guidance 
documents provide recommendations regarding clinical study design for 
devices with indications for use associated with weight loss, include 
discussion on how FDA considers the benefit-risk analysis to support 
such indications, and provide recommendations for the non-clinical 
testing to support premarket submissions for these medical devices. 
These 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DATES: Submit either electronic or written comments on the draft 
guidance by November 14, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2019-N-4060 for ``Medical Devices with Indications Associated with 
Weight Loss--Clinical Study and Benefit-Risk Considerations'' and 
``Medical Devices with Indications Associated with Weight Loss--Non-
Clinical Recommendations.'' 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

[[Page 63590]]

``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 
``Medical Devices with Indications Associated with Weight Loss--
Clinical Study and Benefit-Risk Considerations'' or ``Medical Devices 
with Indications Associated with Weight Loss--Non-Clinical 
Recommendations'' 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: April Marrone, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2604, Silver Spring, MD 20993-0002, 240-402-6510.

SUPPLEMENTARY INFORMATION:

I. Background

    These draft guidance documents provide recommendations regarding 
clinical study design for devices with indications for use associated 
with weight loss, include discussion on how FDA considers the benefit-
risk analysis to support such indications, and provide recommendations 
for non-clinical testing to support premarket submissions for these 
medical devices. These devices may be indicated for weight loss, weight 
reduction, weight management, or obesity treatment in patients who are 
overweight or have obesity. The recommendations and considerations 
reflect current review practices and are intended to promote 
consistency and facilitate efficient review of these submissions.
    Prior to drafting these guidances, FDA requested public comment on 
a concept for balancing the benefit of weight loss with the risks of 
adverse events in a discussion paper (September 2019, Docket No. FDA-
2019-N-4060). FDA considered public comments and incorporated the 
feedback as appropriate in developing the draft guidance, ``Medical 
Devices with Indications Associated with Weight Loss--Clinical Study 
and Benefit-Risk Considerations.''
    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These draft guidance 
documents, when finalized, will represent the current thinking of FDA 
on ``Medical Devices with Indications Associated with Weight Loss--
Clinical Study and Benefit-Risk Considerations'' and ``Medical Devices 
with Indications Associated with Weight Loss--Non-Clinical 
Recommendations.'' They 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 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 or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Medical Devices with Indications 
Associated with Weight Loss--Clinical Study and Benefit-Risk 
Considerations (document number GUI00021016)'' or ``Medical Devices 
with Indications Associated with Weight Loss--Non-Clinical 
Recommendations (document number GUI00019046)'' may send an email 
request to [email protected] 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 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:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
812...............................  Investigational            0910-0078
                                     Device Exemption.
860, subpart D....................  De Novo                    0910-0844
                                     classification
                                     process.
``Requests for Feedback and         Q-Submissions and          0910-0756
 Meetings for Medical Device         Early Payor
 Submissions: The Q-Submission       Feedback Request
 Program''.                          Programs for
                                     Medical Devices.
800, 801, 809, and 830............  Medical Device             0910-0485
                                     Labeling
                                     Regulations; Unique
                                     Device
                                     Identification.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
50, 56............................  Protection of Human        0910-0130
                                     Subjects: Informed
                                     Consent;
                                     Institutional
                                     Review Boards.
58................................  Good Laboratory            0910-0119
                                     Practice (GLP)
                                     Regulations for
                                     Nonclinical
                                     Laboratory Studies.
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[[Page 63591]]

    Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20029 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P