Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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Published

September 20, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Chemical Analysis for Biocompatibility Assessment of Medical Devices." FDA is issuing this draft guidance to describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices.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 This draft guidance is not final nor is it for implementation at this time.

Full Text

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<title>Federal Register, Volume 89 Issue 183 (Friday, September 20, 2024)</title>
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[Federal Register Volume 89, Number 183 (Friday, September 20, 2024)]
[Notices]
[Pages 77162-77164]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Devices; Draft Guidance for Industry and Food and Drug Administration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the availability of the draft guidance entitled ``Chemical Analysis for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draft guidance to describe recommended methodological approaches for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:
<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>.

[[Page 77163]]

<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-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 <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
``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 <a href="/cdn-cgi/l/email-protection#afe0fceae3f0ecebfde7efc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="105f43555c4f53544258507674713e7878633e777f66">[email&#160;protected]</span></a>,
Erica Takai at 301-796-6353, or by email at <a href="/cdn-cgi/l/email-protection#ee8b9c878d8fc09a8f858f87ae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="c4a1b6ada7a5eab0a5afa5ad84a2a0a5eaacacb7eaa3abb2">[email&#160;protected]</span></a>, 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 <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>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. Persons unable to download an electronic copy of
``Chemical Analysis for Biocompatibility Assessment of Medical
Devices'' may send an email request to <a href="/cdn-cgi/l/email-protection#cf8c8b9d87e288baa6abaea1acaa8fa9abaee1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="0f4c4b5d4722487a666b6e616c6a4f696b6e2167677c21686079">[email&#160;protected]</span></a> 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

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