[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Notices]
[Pages 39269-39271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14190]
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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 the guidance entitled ``Use of International
Standard ISO 10993-1, `Biological evaluation of medical devices--Part
1: Evaluation and testing within a risk management process.' '' FDA has
developed this guidance document to assist industry in preparing
Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs),
Investigational Device Applications (IDEs), Premarket Notifications
(510(k)s), and de novo requests for medical devices that come into
direct contact or indirect contact with the human body in order to
determine the potential for an unacceptable adverse biological response
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 International Standard ISO 10993-
1, ``Biological evaluation of medical devices--Part 1: Evaluation and
testing within a risk management process'' to
[[Page 39270]]
support applications to FDA. This guidance supersedes Office of Device
Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled ``Use of
International Standard ISO-10993, `Biological Evaluation of Medical
Devices--Part 1: Evaluation and Testing.' ''
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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 the Center Director, Guidance
and Policy Development, 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: 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
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
in order to determine the potential for an unacceptable adverse
biological response 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 International Standard ISO 10993-
1, ``Biological evaluation of medical devices--Part 1: Evaluation and
testing within a risk management process'' to support applications to
FDA. This guidance supersedes ODE Blue Book Memorandum #G95-1 (1995),
entitled ``Use of International Standard ISO-10993, `Biological
Evaluation of Medical Devices--Part 1: Evaluation and Testing.' ''
The scope of this document is limited to the biological evaluation
of sterile and non-sterile medical devices that come into direct or
indirect contact with the human body and covers the following topics:
Use of risk assessments for biocompatibility evaluations for a proposed
medical device; use of ISO 10993-1 and the FDA-modified matrix to
determine the relevant biocompatibility endpoints for an evaluation;
general biocompatibility testing considerations, including test article
preparation; specific considerations for the following testing:
Cytotoxicity, sensitization, hemocompatibility, pyrogenicity,
implantation, genotoxicity, carcinogenicity, reproductive and
developmental toxicity, and degradation assessments; chemical
assessment recommendations; and considerations for labeling devices as
``-free.''
A draft of this guidance was made available in the Federal Register
on
[[Page 39271]]
April 23, 2013, and the comment period closed on July 22, 2013. The
final guidance was revised in response to the comments to emphasize use
of risk assessment and leveraging of prior information within a
submission to potentially reduce the need for new biocompatibility
testing.
Commenters also requested additional details regarding
biocompatibility testing of devices in contact with gas pathways and
color additives used in medical devices. FDA has determined that these
concepts would be appropriately addressed in separate guidance
documents and have therefore been removed from this final guidance.
II. Significance of 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.
III. 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. 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 1811 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This 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 58 have been approved under
OMB control number 0910-0119; the collections of information in 21 CFR
parts 801 and 809 have been approved under OMB control number 0910-
0485; 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 812 have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 814,
subparts A through E, 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; the collections
of information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; and the collections of information in the guidance
document ``Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug Administration
Staff Requests for Feedback on Medical Device Submissions: The Pre-
Submission Program and Meetings with Food and Drug Administration
Staff'' have been approved under OMB control number 0910-0756.
Dated: June 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14190 Filed 6-15-16; 8:45 am]
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