Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Guidance for Industry and Food and Drug Administration Staff; Availability
| Published date | 11 July 2024 |
| Record Number | 2024-15130 |
| Citation | 89 FR 56886 |
| Court | Food And Drug Administration |
| Section | Notices |
Federal Register, Volume 89 Issue 133 (Thursday, July 11, 2024)
[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
