[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]
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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.
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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:
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OMB control
21 CFR part or guidance Topic No.
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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.
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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