Notice2023-15968
Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
July 28, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder."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. This guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder ("OUD device studies") and used to support marketing submissions. These recommendations are applicable to the design and development of clinical studies to provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD. This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 88 Issue 144 (Friday, July 28, 2023)</title>
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[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48888-48889]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15968]
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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Opioid Use Disorder; Draft Guidance for Industry and Food and Drug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the availability of the draft guidance entitled ``Clinical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. This guidance provides
recommendations for the design of pivotal clinical studies for devices
intended to treat opioid use disorder (``OUD device studies'') and used
to support marketing submissions. These recommendations are applicable
to the design and development of clinical studies to provide a
reasonable assurance of safety and effectiveness for a device intended
to treat OUD. This draft guidance is not final nor is it for
implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by October 26, 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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff 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
``Clinical Considerations for Studies of Devices Intended to Treat
Opioid Use Disorder'' to the Office of Policy, Guidance and Policy
Development, Center for Devices
[[Page 48889]]
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
The opioid overdose crisis is a serious and complex challenge
facing the United States. The Agency has already taken significant
steps to decrease unnecessary exposure to opioids, prevent new cases of
opioid use disorder (OUD) and support the treatment of people with OUD.
The Center for Devices and Radiological Health (CDRH) is committed to
helping to end this national crisis. This guidance provides
recommendations for the design of pivotal clinical studies for devices
intended to treat OUD (hereafter ``OUD device studies'') and used to
support marketing submissions. These recommendations are applicable to
the design and development of clinical studies to provide a reasonable
assurance of safety and effectiveness for a device intended to treat
OUD. OUD device studies designed using the recommendations set out in
this guidance may advance the treatment of OUD by providing scientific
evidence that aids FDA in determining whether there is a reasonable
assurance that a device intended to treat OUD is safe and effective.
These recommendations may change as more information becomes available,
and the research community gains experience with different designs in
relation to OUD device studies.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. 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 draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all CDRH guidance documents is available at <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#11525543593c56647875707f7274517775703f7979623f767e67"><span class="__cf_email__" data-cfemail="de9d9a8c96f399abb7babfb0bdbb9eb8babff0b6b6adf0b9b1a8">[email protected]</span></a> 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.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA guidance have been approved by OMB
as listed in the following table:
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OMB control
Guidance Topic No.
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``Requests for Feedback on Q-submissions.......... 0910-0756
Medical Device Submissions:
The Pre-Submission Program and
Meetings with Food and Drug
Administration Staff''.
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Dated: July 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15968 Filed 7-27-23; 8:45 am]
BILLING CODE 4164-01-P
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