[Federal Register Volume 89, Number 133 (Thursday, July 11, 2024)]
[Notices]
[Pages 56886-56887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15130]



[[Page 56886]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0466]


Clinical Considerations for Studies of Devices Intended To Treat 
Opioid Use Disorder; 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 ``Clinical Considerations 
for Studies of Devices Intended To Treat Opioid Use Disorder.'' Design 
of clinical studies for devices intended to treat opioid use disorder 
(OUD) is challenging. To help spur innovative options to combat the 
opioid overdose crisis and treat OUD, this guidance provides 
recommendations on the design of pivotal clinical studies for devices 
intended to treat OUD (OUD device studies). Through these 
recommendations, FDA intends to aid sponsors in developing OUD device 
studies that provide scientific evidence used to determine whether 
there is a reasonable assurance of safety and effectiveness for 
treating OUD.

DATES: The announcement of the guidance is published in the Federal 
Register on July 11, 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:
     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-0466 for ``Clinical Considerations for Studies of Devices 
Intended To Treat Opioid Use Disorder.'' 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 guidance document entitled 
``Clinical Considerations for Studies of Devices Intended To Treat 
Opioid Use Disorder'' 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: Megha Reddy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2568, Silver Spring, MD 20993-0002, 240-402-2980.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA recognizes the value of medical device innovation to address 
unmet clinical needs arising from the opioid public health emergency in 
the United States. FDA's Center for Devices and Radiological Health 
(CDRH) encourages development of innovative options to combat the 
opioid overdose crisis. To help spur innovative options to combat the 
opioid overdose crisis and treat OUD, this guidance provides 
recommendations on the design of pivotal OUD device studies. Through 
these recommendations, FDA intends to aid sponsors in developing OUD 
device studies that provide scientific evidence used to determine 
whether there is a reasonable assurance of safety and effectiveness for 
treating OUD. Because of the complexity of OUD, there are many 
challenges in designing OUD device studies. These challenges

[[Page 56887]]

include inaccurate participant reports of drug use, high rates of 
missing data, the confounding effects of concomitant drug treatments, 
and the need to demonstrate the durability of the device's treatment 
effect, which can necessitate prolonged observation.
    A notice of availability of the draft guidance appeared in the 
Federal Register of July 28, 2023 (88 FR 48888). FDA considered 
comments received and has made some minor edits for clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Clinical Considerations for Studies of 
Devices Intended To Treat Opioid Use Disorder. 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.

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 CDRH 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 
and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of ``Clinical 
Considerations for Studies of Devices Intended To Treat Opioid Use 
Disorder'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number GUI00019017 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                              OMB control
              form                        Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
``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.
860, subpart D.................  De Novo classification        0910-0844
                                  process.
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    Dated: July 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15130 Filed 7-10-24; 8:45 am]
BILLING CODE 4164-01-P