Document ID: FDA-2013-D-0350-0053
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2023-09-08T04:00Z

[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