[Federal Register Volume 89, Number 183 (Friday, September 20, 2024)]
[Notices]
[Pages 77162-77164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21575]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-4165]


Chemical Analysis for Biocompatibility Assessment of Medical 
Devices; Draft Guidance for Industry and Food and Drug Administration 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the availability of the draft guidance entitled ``Chemical Analysis for 
Biocompatibility Assessment of Medical Devices.'' FDA is issuing this 
draft guidance to describe recommended methodological approaches for 
chemical analysis for biocompatibility assessment of medical devices. 
The biocompatibility of medical devices is evaluated based on the 
duration of exposure and nature of contact with the body. Chemical 
characterization is one approach that manufacturers can consider when 
developing a strategy for the overall biocompatibility assessment of a 
device. This draft guidance is not final nor is it for implementation 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DATES: Submit either electronic or written comments on the draft 
guidance by November 19, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.

[[Page 77163]]

     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-4165 for ``Chemical Analysis for Biocompatibility Assessment 
of Medical Devices.'' 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 
``Chemical Analysis for Biocompatibility Assessment of Medical 
Devices'' 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: The Office of Science and Engineering 
Laboratories (OSEL), Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Silver 
Spring, MD 20993-0002, 301-796-2530, or by email [email protected], 
Erica Takai at 301-796-6353, or by email at [email protected], or 
James Myers, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this draft guidance to describe recommended 
methodological approaches for chemical analysis for biocompatibility 
assessment of medical devices. The biocompatibility of medical devices 
is evaluated based on the duration of exposure and nature of contact 
with the body. Chemical characterization is one approach that 
manufacturers can consider when developing a strategy for the overall 
biocompatibility assessment of a device. Chemical characterization can 
be an alternative to biological testing for evaluating some 
biocompatibility endpoints. Use of chemical characterization can reduce 
the time needed to complete biocompatibility testing, reduce animal 
testing, generate data on the chemical constituents of a device, and be 
used to evaluate multiple biocompatibility endpoints at once. FDA and 
other stakeholders have observed variability in the approaches of 
individual laboratories performing analytical chemistry testing that 
has resulted in inconsistent analytical chemistry reports. The 
recommendations in this guidance are intended to improve the 
consistency and reliability of analytical chemistry 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 ``Chemical 
Analysis for Biocompatibility Assessment of Medical Devices.'' 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Chemical Analysis for Biocompatibility Assessment of Medical 
Devices'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number GUI00020037 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

[[Page 77164]]

information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations, guidance, and forms 
have been approved by OMB as listed in the following table:

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                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               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 Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
860, subpart D....................  De Novo                    0910-0844
                                     classification
                                     process.
``Requests for Feedback on Medical  Q-Submissions and          0910-0756
 Device Submissions: The Q-          Early Payor
 Submission Program and Meetings     Feedback Request
 with Food and Drug Administration   Programs for
 Staff''.                            Medical Devices.
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    Dated: September 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21575 Filed 9-19-24; 8:45 am]
BILLING CODE 4164-01-P