[Federal Register Volume 78, Number 78 (Tuesday, April 23, 2013)]
[Notices]
[Pages 23940-23941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09479]


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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, ``Biological Evaluation 
of Medical Devices Part 1: Evaluation and Testing''; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Use of International 
Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: 
Evaluation and Testing.' '' FDA has developed this guidance document to 
assist industry in preparing premarket applications (PMAs), 
humanitarian device exemptions (HDEs), investigational device 
applications (IDEs), premarket notifications (510(k)s), and de novo 
requests for medical devices that come into direct or indirect contact 
with the human body in order to determine the potential toxicity 
resulting from contact of the component materials of the device with 
the body.
    The purpose of this guidance is to provide further clarification 
and updated information on the use of the Office of Device Evaluation 
(ODE) General Program Memorandum G95-1 entitled ``Use of 
International Standard ISO-10993, `Biological Evaluation of Medical 
Devices Part 1: Evaluation and Testing,' '' dated May 1, 1995. When 
final, this guidance will therefore replace G95-1.
    This draft guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 22, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Use of International Standard ISO-10993, 
`Biological Evaluation of Medical Devices Part 1: Evaluation and 
Testing' '' to the Division of Small Manufacturers, International, and 
Consumer Assistance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jennifer Goode, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1212, Silver Spring, MD 20993-0002, 301-796-6374.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this guidance document to assist industry in 
preparing PMAs, HDEs, IDEs, 510(k)s, and de novo requests for medical 
devices that come into direct or indirect contact with the human body 
in order to determine the potential toxicity resulting from contact of 
the component materials of the device with the body.
    The purpose of this guidance is to provide further clarification 
and updated information on the use of ODE General Program Memorandum 
G95-1 entitled ``Use of International Standard ISO-10993, 
`Biological Evaluation of Medical Devices Part 1: Evaluation and 
Testing,' '' dated May 1, 1995. When final, this guidance will 
therefore replace G95-1. This guidance document also 
incorporates several new considerations, including assessment of known 
or potentially toxic chemicals (e.g., color additives), and sample 
preparation for submicron or nanotechnology components, in situ 
polymerizing, and bioabsorbable materials, which were not previously 
discussed in G95-1. The scope of this document is limited to 
the biological evaluation of sterile and nonsterile medical devices 
that come into direct or indirect contact with the human body. This 
document addresses the following issues: (1) Test selection; (2) 
general testing considerations, including sample preparation; (3) 
specific considerations for the following testing: Cytotoxicity, 
sensitization, hemocompatibility, pyrogenicity, implantation, 
genotoxicity, carcinogenicity, reproductive and developmental toxicity, 
and biodegradation; (4) use of

[[Page 23941]]

animal safety studies to justify omission of specific biocompatibility 
tests; (5) assessment of known or potentially toxic chemical entities; 
and (6) contents of a biocompatibility test report.

II. Significance of Guidance

    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 Agency's current thinking on the use of 
International Standard ISO-10993, ``Biological Evaluation of Medical 
Devices Part 1: Evaluation and Testing.'' It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all Center for 
Devices and Radiological Health guidance documents is available at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov.
    To receive ``Use of International Standard ISO-10993, `Biological 
Evaluation of Medical Devices Part 1: Evaluation and Testing,' '' you 
may either send an email request to [email protected] to receive an 
electronic copy of the document or send a fax request to 301-847-8149 
to receive a hard copy. Please use the document number 1811 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 814, have been approved under OMB control 
number 0910-0231; the collections of information in 21 CFR part 814, 
subpart H, have been approved under OMB control number 0910-0332; and 
the collections of information in 21 CFR part 812, have been approved 
under OMB control number 0910-0078.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: April 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09479 Filed 4-22-13; 8:45 am]
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