Notice2024-05584
Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
March 15, 2024
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling." FDA is issuing this draft guidance document to describe relevant information that should be provided in premarket submissions to support the evaluation of thermal effects of medical devices that produce local, regional, and/or systemic changes in tissue temperature (i.e., heating and/or cooling) due to their use. The recommendations in this draft guidance reflect current review practices and are intended to promote consistency and facilitate efficient review of thermal effects data in premarket submissions for these devices. This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 89 Issue 52 (Friday, March 15, 2024)</title>
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[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Notices]
[Pages 18944-18945]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05584]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-0664]
Evaluation of Thermal Effects of Medical Devices That Produce
Tissue Heating and/or Cooling; Draft Guidance for Industry and Food and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the availability of the draft guidance entitled ``Evaluation of Thermal
Effects of Medical Devices That Produce Tissue Heating and/or
Cooling.'' FDA is issuing this draft guidance document to describe
relevant information that should be provided in premarket submissions
to support the evaluation of thermal effects of medical devices that
produce local, regional, and/or systemic changes in tissue temperature
(i.e., heating and/or cooling) due to their use. The recommendations in
this draft guidance reflect current review practices and are intended
to promote consistency and facilitate efficient review of thermal
effects data in premarket submissions for these devices. 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 May 14, 2024 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-2024-D-0664 for ``Evaluation of Thermal Effects of Medical Devices
that Produce Tissue Heating and/or Cooling.'' 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
``Evaluation of Thermal Effects of Medical Devices that Produce Tissue
Heating and/or Cooling'' 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: Devashish Shrivastava, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4628, Silver Spring, MD 20993-0002,
301-796-5459.
SUPPLEMENTARY INFORMATION:
I. Background
When a change in tissue temperature occurs because of device
heating and/or cooling, there is a potential for adverse health
effects, such as tissue damage or a negative impact on physiological
functions. This draft guidance provides FDA's recommendations for
evaluation of thermal effects for devices that produce changes in
tissue temperature (heating and/or cooling) as an intended or
unintended consequence of device use. The draft guidance describes when
[[Page 18945]]
experimental methods (i.e., phantom, ex vivo tissue, and/or in vivo
tissue models), computational methods, and/or clinical studies may be
appropriate to assess thermal effects.
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 ``Evaluation
of Thermal Effects of Medical Devices That Produce Tissue Heating and/
or Cooling.'' 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 Center for Devices and Radiological Health 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 ``Evaluation of Thermal Effects of
Medical Devices that Produce Tissue Heating and/or Cooling'' may send
an email request to <a href="/cdn-cgi/l/email-protection#b7f4f3e5ff9af0c2ded3d6d9d4d2f7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="bbf8ffe9f396fcced2dfdad5d8defbdddfda95d3d3c895dcd4cd">[email protected]</span></a> to receive an electronic
copy of the document. Please use the document number GUI00022002 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 or guidance Topic OMB control No.
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807, subpart E............... Premarket 0910-0120
notification.
814, subparts A through E.... Premarket approval... 0910-0231
814, subpart H............... Humanitarian Use 0910-0332
Devices;
Humanitarian Device
Exemption.
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 Feedback
Submissions: The Q- Request Programs for
Submission Program''. Medical Devices.
800, 801, 809, and 830....... Medical Device 0910-0485
Labeling
Regulations; Unique
Device
Identification.
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Dated: March 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05584 Filed 3-14-24; 8:45 am]
BILLING CODE 4164-01-P
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