Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process”; Guidance for Industry and Food and Drug Administration Staff; Availability, 62091-62093 [2023-19402]
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Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices
Developing Drugs for Treatment.’’ 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. Paperwork Reduction Act of 1995
While this guidance contains no
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 21 CFR part 312 relating
to the submissions of investigational
new drug applications have been
approved under OMB control number
0910–0014. The collections of
information in 21 CFR part 314 relating
to the submissions of new drug
applications and abbreviated new drug
applications have been approved under
OMB control number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19419 Filed 9–7–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0350]
Use of International Standard ISO
10993–1, ‘‘Biological Evaluation of
Medical Devices—Part 1: Evaluation
and Testing Within a Risk Management
Process’’; Guidance for Industry and
Food and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
lotter on DSK11XQN23PROD with NOTICES1
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Use of International
Standard ISO 10993–1, ‘Biological
evaluation of medical devices—Part 1:
SUMMARY:
VerDate Sep<11>2014
17:30 Sep 07, 2023
Jkt 259001
Evaluation and testing within a risk
management process’.’’ This guidance
was revised to incorporate updates to
FDA’s current thinking regarding the
type of biocompatibility information
that should be provided in a premarket
submission for certain devices made
from common polymers and fabrics that
are in contact with intact skin. The
purpose of this guidance is to provide
further clarification and updated
information on the use of International
Standard ISO 10993–1, ‘‘Biological
evaluation of medical devices—Part 1:
Evaluation and testing within a risk
management process’’ to support
premarket approval applications
(PMAs), humanitarian device
exemptions (HDEs), investigational
device exemption (IDE) applications,
premarket notifications (510(k)s), and
De Novo requests.
DATES: The announcement of the
guidance is published in the Federal
Register on September 8, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
62091
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–
2013–D–0350 for ‘‘Use of International
Standard ISO 10993–1, ‘Biological
evaluation of medical devices—Part 1:
Evaluation and testing within a risk
management process’.’’ 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-201509-18/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
E:\FR\FM\08SEN1.SGM
08SEN1
62092
Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices
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 guidance
document entitled ‘‘Use of International
Standard ISO 10993–1, ‘Biological
evaluation of medical devices—Part 1:
Evaluation and testing within a risk
management process’ ’’ 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; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT:
Jennifer Goode, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1656, Silver Spring,
MD 20993–0002, 301–796–5701; or
Anne Taylor, 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
lotter on DSK11XQN23PROD with NOTICES1
On September 4, 2020, FDA issued a
guidance entitled ‘‘Use of International
Standard ISO 10993–1, ‘Biological
evaluation of medical devices—Part 1:
Evaluation and testing within a risk
management process’ ’’ (‘‘2020
Biocompatibility Guidance’’). The 2020
Biocompatibility Guidance was
developed to assist industry with PMAs,
HDEs, IDEs, 510(k)s, and De Novo
requests for medical devices that come
into direct contact or indirect contact
with the human body to determine the
potential for an unacceptable adverse
biological response resulting from
contact of the component materials of
the device with the body.
On October 15, 2020, FDA issued a
draft guidance entitled ‘‘Select Updates
for Biocompatibility of Certain Devices
in Contact with Intact Skin’’ (the Select
Updates Guidance) which proposed
updates to the 2020 Biocompatibility
Guidance regarding the type of
biocompatibility information that
should be provided in a premarket
submission for certain devices made
from common synthetic polymers and
natural fabrics that are in contact with
intact skin. A notice of availability of
the draft guidance appeared in the
Federal Register of October 15, 2020 (85
FR 65410).
FDA is issuing this guidance to
incorporate content from the Select
Updates Guidance. FDA considered
comments received to the Select
Updates Guidance, and we revised the
guidance as appropriate in response to
the comments, including addition of
materials to the list of those included in
the policy and clarification of the
following: applicability of the policy to
device components, devices or
components made from multiple
materials, and materials including
processing chemicals; situations where
additional discussion on applicability of
the policy is recommended; and
clarification on characteristics of
devices or materials to which this policy
does not apply. In addition, FDA made
minor updates to the guidance to align
with the current recognized versions of
consensus standards. This guidance
supersedes the 2020 Biocompatibility
Guidance.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on Use of International
Standard ISO 10993–1, ‘‘Biological
evaluation of medical devices—Part 1:
Evaluation and testing within a risk
management process.’’ 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 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-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-bloodbiologics/guidance-complianceregulatory-information-biologics.
Persons unable to download an
electronic copy of ‘‘Use of International
Standard ISO 10993–1, ‘Biological
evaluation of medical devices—Part 1:
Evaluation and testing within a risk
management process’ ’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number GUI00001811 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 OMB under the PRA. The
collections of information in the
following table have been approved by
OMB:
OMB control
No.
21 CFR part or guidance
Topic
807, subpart E ............................................................................
814, subparts A through E ..........................................................
814, subpart H ............................................................................
812 ..............................................................................................
860, subpart D ............................................................................
‘‘Requests for Feedback on Medical Device Submissions: The
Q-Submission Program and Meetings with Food and Drug
Administration Staff’’.
800, 801, 809, and 830 ..............................................................
Premarket notification ................................................................
Premarket approval ....................................................................
Humanitarian Device Exemption ...............................................
Investigational Device Exemption ..............................................
De Novo classification process ..................................................
Q-Submissions and Early Payor Feedback Request Programs
for Medical Devices.
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
0910–0756
Medical Device Labeling Regulations; Unique Device Identification.
0910–0485
VerDate Sep<11>2014
17:30 Sep 07, 2023
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Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices
Topic
803 ..............................................................................................
Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor
reporting.
Postmarket Surveillance of Medical Devices ............................
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.
Good Laboratory Practice (GLP) Regulations for Nonclinical
Laboratory Studies.
58 ................................................................................................
Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19402 Filed 9–7–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4848]
Application of Human Factors
Engineering Principles for
Combination Products: Questions and
Answers; Guidance for Industry and
FDA Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry and FDA staff
entitled ‘‘Application of Human Factors
Engineering Principles for Combination
Products: Questions and Answers.’’ This
document provides questions and
answers for industry and FDA staff on
the application of human factors
engineering (HFE) principles to the
development of combination products
as defined under the regulations. The
guidance clarifies how the unique
aspects of a combination product
influence the considerations within the
HFE process. This guidance is intended
to facilitate the development of
combination products. This guidance
finalizes the draft guidance entitled
‘‘Human Factors Studies and Related
Clinical Study Considerations in
Combination Product Design and
Development’’ issued on February 3,
2016.
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
OMB control
No.
21 CFR part or guidance
822 ..............................................................................................
820 ..............................................................................................
The announcement of the
guidance is published in the Federal
Register on September 8, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
VerDate Sep<11>2014
17:30 Sep 07, 2023
Jkt 259001
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–
2015–D–4848 for ‘‘Application of
Human Factors Engineering Principles
for Combination Products: Questions
and Answers.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
62093
0910–0437
0910–0449
0910–0073
0910–0119
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-201509-18/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)).
Submit written requests for single
copies of this guidance to the Office of
E:\FR\FM\08SEN1.SGM
08SEN1
]]>Agencies
[Federal Register Volume 88, Number 173 (Friday, September 8, 2023)]
[Notices]
[Pages 62091-62093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19402]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0350]
Use of International Standard ISO 10993-1, ``Biological
Evaluation of Medical Devices--Part 1: Evaluation and Testing Within a
Risk Management Process''; Guidance for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Use of International
Standard ISO 10993-1, `Biological evaluation of medical devices--Part
1: Evaluation and testing within a risk management process'.'' This
guidance was revised to incorporate updates to FDA's current thinking
regarding the type of biocompatibility information that should be
provided in a premarket submission for certain devices made from common
polymers and fabrics that are in contact with intact skin. The purpose
of this guidance is to provide further clarification and updated
information on the use of International Standard ISO 10993-1,
``Biological evaluation of medical devices--Part 1: Evaluation and
testing within a risk management process'' to support premarket
approval applications (PMAs), humanitarian device exemptions (HDEs),
investigational device exemption (IDE) applications, premarket
notifications (510(k)s), and De Novo requests.
DATES: The announcement of the guidance is published in the Federal
Register on September 8, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2013-D-0350 for ``Use of International Standard ISO 10993-1,
`Biological evaluation of medical devices--Part 1: Evaluation and
testing within a risk management process'.'' 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
[[Page 62092]]
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 guidance document entitled ``Use
of International Standard ISO 10993-1, `Biological evaluation of
medical devices--Part 1: Evaluation and testing within a risk
management process' '' 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; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Jennifer Goode, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1656, Silver Spring, MD 20993-0002, 301-796-5701;
or Anne Taylor, 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
On September 4, 2020, FDA issued a guidance entitled ``Use of
International Standard ISO 10993-1, `Biological evaluation of medical
devices--Part 1: Evaluation and testing within a risk management
process' '' (``2020 Biocompatibility Guidance''). The 2020
Biocompatibility Guidance was developed to assist industry with PMAs,
HDEs, IDEs, 510(k)s, and De Novo requests for medical devices that come
into direct contact or indirect contact with the human body to
determine the potential for an unacceptable adverse biological response
resulting from contact of the component materials of the device with
the body.
On October 15, 2020, FDA issued a draft guidance entitled ``Select
Updates for Biocompatibility of Certain Devices in Contact with Intact
Skin'' (the Select Updates Guidance) which proposed updates to the 2020
Biocompatibility Guidance regarding the type of biocompatibility
information that should be provided in a premarket submission for
certain devices made from common synthetic polymers and natural fabrics
that are in contact with intact skin. A notice of availability of the
draft guidance appeared in the Federal Register of October 15, 2020 (85
FR 65410).
FDA is issuing this guidance to incorporate content from the Select
Updates Guidance. FDA considered comments received to the Select
Updates Guidance, and we revised the guidance as appropriate in
response to the comments, including addition of materials to the list
of those included in the policy and clarification of the following:
applicability of the policy to device components, devices or components
made from multiple materials, and materials including processing
chemicals; situations where additional discussion on applicability of
the policy is recommended; and clarification on characteristics of
devices or materials to which this policy does not apply. In addition,
FDA made minor updates to the guidance to align with the current
recognized versions of consensus standards. This guidance supersedes
the 2020 Biocompatibility Guidance.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Use of International Standard ISO 10993-1,
``Biological evaluation of medical devices--Part 1: Evaluation and
testing within a risk management process.'' 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 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
``Use of International Standard ISO 10993-1, `Biological evaluation of
medical devices--Part 1: Evaluation and testing within a risk
management process' '' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00001811 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
OMB under the PRA. The collections of information in the following
table have been approved by OMB:
------------------------------------------------------------------------
OMB control
21 CFR part or guidance Topic No.
------------------------------------------------------------------------
807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
814, subpart H................. Humanitarian Device 0910-0332
Exemption.
812............................ Investigational Device 0910-0078
Exemption.
860, subpart D................. De Novo classification 0910-0844
process.
``Requests for Feedback on Q-Submissions and Early 0910-0756
Medical Device Submissions: Payor Feedback Request
The Q-Submission Program and Programs for Medical
Meetings with Food and Drug Devices.
Administration Staff''.
800, 801, 809, and 830......... Medical Device Labeling 0910-0485
Regulations; Unique
Device Identification.
[[Page 62093]]
803............................ Medical Devices; 0910-0437
Medical Device
Reporting;
Manufacturer
reporting, importer
reporting, user
facility reporting,
distributor reporting.
822............................ Postmarket Surveillance 0910-0449
of Medical Devices.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
58............................. Good Laboratory 0910-0119
Practice (GLP)
Regulations for
Nonclinical Laboratory
Studies.
------------------------------------------------------------------------
Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19402 Filed 9-7-23; 8:45 am]
BILLING CODE 4164-01-P
