[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Notices]
[Pages 18944-18945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Tissue Heating and/or Cooling; Draft Guidance for Industry and Food and 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the availability of the draft guidance entitled ``Evaluation of Thermal 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 FDA is issuing this draft guidance document to describe 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this draft guidance reflect current review practices and are intended 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 This draft 
guidance is not final nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by May 14, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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 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 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 ``Evaluation of Thermal Effects of 
Medical Devices that Produce Tissue Heating and/or Cooling'' may send 
an email request to [email protected] 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:

------------------------------------------------------------------------
   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