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, 39269-39271 [2016-14190]
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39269
Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices
Desk Officer for the Administration for
Children and Families.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
Administration for Children and
Families
[FR Doc. 2016–14244 Filed 6–15–16; 8:45 am]
The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR), announces
the award of two single-source program
expansion supplement grants for a total
of $16,476,723 under the
Unaccompanied Children’s (UC)
Program.
SUMMARY:
[CFDA Number: 93.676]
BILLING CODE 4184–01–P
Notice of award of two singlesource program expansion supplement
grants under the Unaccompanied
Children’s (UC) Program.
ACTION:
Announcement of the Award of Two
Single-Source Program Expansion
Supplement Grants Under the
Unaccompanied Children’s (UC)
Program
Office of Refugee Resettlement,
ACF, HHS.
AGENCY:
Location
BCFS Health and Human Services ................................................................
Southwest Key, Inc .........................................................................................
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Organization
San Antonio, TX .....................................................
Austin, TX ...............................................................
ORR has been identifying additional
capacity to provide shelter for potential
increases in apprehensions of
Unaccompanied Children at the U.S.
Southern Border. Planning for increased
shelter capacity is a prudent step to
ensure that ORR is able to meet its
responsibility, by law, to provide shelter
for Unaccompanied Children referred to
its care by the Department of Homeland
Security (DHS).
The expansion supplement grants will
support the need to increase shelter
capacity to accommodate the increasing
numbers of UCs being referred by DHS.
Both grantees have the infrastructure,
licensing, experience and appropriate
level of trained staff to meet the service
requirements and the urgent need for
expansion of services. The grantees
provide residential services to UC in the
care and custody of ORR, as well as
services to include counseling, case
management, and additional support
services to the family or to the UC and
their sponsor when a UC is released
from ORR’s care and custody.
DATES: Supplemental award funds will
support activities from October 1, 2015,
through September 30, 2016.
FOR FURTHER INFORMATION CONTACT:
Jallyn Sualog, Director, Division of
Children’s Services, Office of Refugee
Resettlement, 330 C. Street SW.,
Washington, DC 20201. Email:
DCSProgram@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: ORR is
continuously monitoring its capacity to
shelter the unaccompanied children
referred to HHS, as well as the
information received from interagency
partners, to inform any future decisions
or actions.
ORR has specific requirements for the
provision of services. Award recipients
must have the infrastructure, licensing,
VerDate Sep<11>2014
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Jkt 238001
Amount
$9,525,387
6,951,336
experience, and appropriate level of
trained staff to meet those requirements.
The expansion of the existing program
and its services through this
supplemental award is a key strategy for
ORR to be prepared to meet its
responsibility to provide shelter for
Unaccompanied Children referred to its
care by DHS and so that the US Border
Patrol can continue its vital national
security mission to prevent illegal
migration, trafficking, and protect the
borders of the United States.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Statutory Authority: This program is
authorized by—
(A) Section 462 of the Homeland Security
Act of 2002, which in March 2003,
transferred responsibility for the care and
custody of Unaccompanied Alien Children
from the Commissioner of the former
Immigration and Naturalization Service (INS)
to the Director of ORR of the Department of
Health and Human Services (HHS).
(B) The Flores Settlement Agreement, Case
No. CV85–4544RJK (C.D. Cal. 1996), as well
as the William Wilberforce Trafficking
Victims Protection Reauthorization Act of
2008 (Pub. L. 110–457), which authorizes
post release services under certain conditions
to eligible children. All programs must
comply with the Flores Settlement
Agreement, Case No. CV85–4544–RJK (C.D.
Cal. 1996), pertinent regulations and ORR
policies and procedures.
AGENCY:
Christopher Beach,
Senior Grants Policy Specialist, Office of
Administration, Office of Financial Services,
Division of Grants Policy.
[FR Doc. 2016–14267 Filed 6–15–16; 8:45 am]
BILLING CODE 4184–01–P
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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
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
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
SUMMARY:
E:\FR\FM\16JNN1.SGM
16JNN1
39270
Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices
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.’ ’’
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:
DATES:
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’’).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
18:04 Jun 15, 2016
Jkt 238001
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 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 https://
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: https://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 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 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
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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 selfaddressed 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
E:\FR\FM\16JNN1.SGM
16JNN1
Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices
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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://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
CDRH-Guidance@fda.hhs.gov 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;
VerDate Sep<11>2014
18:04 Jun 15, 2016
Jkt 238001
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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Pediatric Clinical Investigator Training;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration’s (FDA) Office of
Pediatric Therapeutics, and the Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
are announcing a 2-day public
workshop entitled ‘‘Pediatric Clinical
Investigator Training.’’ The purpose of
this workshop is to provide
investigators with training and expertise
in designing and conducting clinical
trials in pediatric patients that will lead
to appropriate labeling. Although we
have learned a lot about conducting
pediatric trials over the past two
decades, there are still challenges that
need to be addressed. The training
SUMMARY:
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39271
course is intended to provide
investigators with: (1) A clear
understanding of some of the challenges
of studying products in the pediatric
population, including: Pediatric study
design, neonates, biomarkers,
endpoints, orphan drugs and rare
disease trial design, formulations; (2) an
overview of extrapolation as it relates to
the pediatric population; and (3) an
overview of ethically appropriate
methods related to the design of clinical
trials in the pediatric population.
DATES: The public workshop will be
held on September 12 and 13, 2016,
from 8 a.m. to 4 p.m. Registration to
attend the workshop should be
completed by September 6, 2016. (See
the SUPPLEMENTARY INFORMATION section
for instructions).
ADDRESSES: This public workshop will
be held at the DoubleTree Bethesda,
8120 Wisconsin Ave., Bethesda, MD
20814.
FOR FURTHER INFORMATION CONTACT:
Terrie L. Crescenzi, Office of Pediatric
Therapeutics, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
terrie.crescenzi@fda.hhs.gov; or Betsy
Sanford, Office of Pediatric
Therapeutics, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
elizabeth.sanford@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In July 2012, the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144) made permanent
the pediatric initiatives, Best
Pharmaceuticals for Children Act
(BPCA) and Pediatric Research Equity
Act, which have stimulated pediatric
research over the past two decades. The
National Institutes of Health section of
BPCA legislation, however, is due for
reauthorization in 2017. Though much
progress has been made, pediatric trials
for the purpose of developing product
use information are still performed less
frequently than adult trials. As such,
current standards for trials are much
more oriented to adult scientific,
ethical, and clinical processes. This
situation is due, in part, to the fact that
pediatric trials have both scientific
challenges and unique attributes and
requirements which must be met if the
data are to be accepted or used by FDA.
The development of safe and effective
products in the pediatric population
presents many challenges. These
challenges include trial design,
appropriate endpoints, extrapolation of
data from adults, and ethical issues. It
is extremely important that pediatric
E:\FR\FM\16JNN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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 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: 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): 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 https://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 https://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: https://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 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 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://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 CDRH-Guidance@fda.hhs.gov 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]
BILLING CODE 4164-01-P
