Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 044, 48809-48813 [2016-17570]
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Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
044
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing a publication containing
modifications the Agency is making to
the list of standards FDA recognizes for
use in premarket reviews (FDA
Recognized Consensus Standards). This
publication, entitled Modifications to
the List of Recognized Standards,
Recognition List Number: 044
(Recognition List Number: 044), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: Submit electronic or written
comments concerning this document at
any time. These modifications to the list
of recognized standards are effective
July 26, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
srobinson on DSK5SPTVN1PROD with NOTICES
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
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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–
2004–N–0451 for ‘‘Food and Drug
Administration Modernization Act of
1997: Modifications to the List of
Recognized Standards, Recognition List
Number: 044.’’ 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. FDA will consider any
comments received in determining
whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
043.
• 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
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48809
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 Recognition List
Number: 044 is available on the Internet
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
VI of this document for electronic access
to the searchable database for the
current list of FDA recognized
consensus standards, including
Recognition List Number: 044
modifications and other standards
related information. Submit written
requests for a single hard copy of the
document entitled ‘‘Modifications to the
List of Recognized Standards,
Recognition List Number: 044’’ to Scott
A. Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring,
MD 20993. Send one self-addressed
adhesive label to assist that office in
processing your request, or fax your
request to 301–847–8149.
FOR FURTHER INFORMATION CONTACT:
Scott A. Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring,
MD 20993, 301–796–6287, standards@
cdrh.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115)
amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize
consensus standards developed by
international and national organizations
for use in satisfying portions of device
premarket review submissions or other
requirements.
In a notice published in the Federal
Register of February 25, 1998 (63 FR
9561), FDA announced the availability
of a guidance entitled ‘‘Recognition and
Use of Consensus Standards.’’ The
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notice described how FDA would
implement its standard recognition
program and provided the initial list of
recognized standards.
Modifications to the initial list of
recognized standards, as published in
the Federal Register, can be accessed at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm.
These notices describe the addition,
withdrawal, and revision of certain
standards recognized by FDA. The
Agency maintains hypertext markup
language (HTML) and portable
document format (PDF) versions of the
list of FDA Recognized Consensus
Standards. Both versions are publicly
accessible at the Agency’s Internet site.
See section VI of this document for
electronic access information. Interested
persons should review the
supplementary information sheet for the
standard to understand fully the extent
to which FDA recognizes the standard.
II. Modifications to the List of
Recognized Standards, Recognition List
Number: 044
FDA is announcing the addition,
withdrawal, correction, and revision of
certain consensus standards the Agency
will recognize for use in premarket
submissions and other requirements for
devices. FDA will incorporate these
modifications in the list of FDA
Recognized Consensus Standards in the
Agency’s searchable database. FDA will
use the term ‘‘Recognition List Number:
044’’ to identify these current
modifications.
In table 1, FDA describes the
following modifications: (1) The
withdrawal of standards and their
replacement by others, if applicable; (2)
the correction of errors made by FDA in
listing previously recognized standards;
and (3) the changes to the
supplementary information sheets of
recognized standards that describe
revisions to the applicability of the
standards.
In section III, FDA lists modifications
the Agency is making that involve the
initial addition of standards not
previously recognized by FDA.
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Old recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
A. Biocompatibility
........................
2–94 ...................
........................
2–114 .................
........................
2–117 .................
2–226
2–118 .................
........................
2–119 .................
........................
2–120 .................
........................
2–122 .................
........................
2–124 .................
........................
2–126 .................
........................
2–133 .................
........................
2–134 .................
........................
2–136 .................
........................
2–141 .................
........................
2–142 .................
2–227
2–145 .................
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2–93 ...................
........................
2–153 .................
........................
2–155 .................
........................
2–156 .................
........................
2–162 .................
........................
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ASTM F763–04 (Reapproved 2010) Standard Practice for Short-Term
Screening of Implant Materials.
ASTM F981–04 (Reapproved 2010) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone.
ASTM F1877–05 (Reapproved 2010) Standard Practice for Characterization of Particles.
ANSI/AAMI/ISO 10993–3:2014 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.
ANSI/AAMI/ISO 10993–11:2006/(R) 2014 Biological evaluation of
medical devices—Part 11: Tests for systemic toxicity.
ASTM F813–07 (Reapproved 2012) Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices.
ANSI/AAMI/ISO 10993–6:2007/(R) 2014 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation.
ASTM F719–81 (Reapproved 2012) Standard Practice for Testing
Biomaterials in Rabbits for Primary Skin Irritation.
ASTM F750–87 (Reapproved 2012) Standard Practice for Evaluating
Material Extracts By Systemic Injection in the Mouse.
ASTM F748–06 (Reapproved 2010) Standard Practice for Selecting
Generic Biological Test Methods for Materials and Devices.
ASTM F1408–97 (Reapproved 2013) Standard Practice for Subcutaneous Screening Test for Implant Materials.
ASTM F2065–00 (Reapproved 2010) Standard Practice for Testing for
Alternative Pathway Complement Activation in Serum by Solid Materials.
ASTM E1262–88 (Reapproved 2013) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine
Phosphoribosyl Transferase Gene Mutation Assay.
ASTM F1984–99 (Reapproved 2013) Standard Practice for Testing for
Whole Complement Activation in Serum by Solid Materials.
ASTM F1983–14 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications.
ASTM F1439–03 (Reapproved 2013) Standard Guide for Performance
of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials.
ANSI/AAMI/ISO 10993–5:2009/(R) 2014 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity.
ASTM F2147–01 (Reapproved 2010) Standard Practice for Guinea
Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens.
ANSI/AAMI 10993–1:2009/(R) 2013 Biological evaluation of medical
devices—Part 1: Evaluation and testing within a risk management
process [Including: Technical Corrigendum 1 (2010)].
ASTM F1903–10 Standard Practice for Testing For Biological Responses to Particles In Vitro.
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Extent of recognition,
guidance.
Extent of recognition,
guidance.
Relevant
Relevant
Extent of recognition, Relevant
guidance.
Withdrawn and replaced with
newer version.
Reaffirmation, Extent of recognition, Relevant guidance.
Extent of recognition, Relevant
guidance.
Reaffirmation, Extent of recognition, Relevant guidance.
Extent of recognition, Relevant
guidance.
Extent of recognition, Relevant
guidance.
Extent of recognition, Relevant
guidance.
Extent of recognition, Relevant
guidance.
Extent of recognition, Relevant
guidance.
Extent of recognition,
guidance.
Relevant
Extent of recognition, Relevant
guidance.
Withdrawn and replaced with
newer version.
Extent of recognition, Relevant
guidance.
Extent of recognition,
guidance.
Extent of recognition,
guidance.
Extent of recognition,
guidance.
Relevant
Extent of recognition,
guidance.
Relevant
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Relevant
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
recognition
No.
2–163 .................
........................
2–165 .................
........................
2–167 .................
........................
2–168 .................
........................
2–169 .................
........................
2–170 .................
........................
2–171 .................
........................
2–172 .................
........................
2–173 .................
........................
2–174 .................
........................
2–175 .................
2–228
2–176 .................
........................
2–177 .................
........................
2–180 .................
........................
2–189 .................
........................
2–190 .................
........................
2–191 .................
........................
2–197 .................
........................
2–198 .................
........................
2–204 .................
........................
2–206 .................
........................
2–207 .................
........................
2–213 .................
........................
2–214 .................
........................
2–215 .................
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Old recognition
No.
2–229
2–216 .................
2–230
2–217 .................
2–231
2–218 .................
........................
2–219 .................
........................
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Title of standard 1
Change
ANSI/AAMI/ISO 10993–9: 2009/(R) 2014 Biological evaluation of
medical devices—Part 9: Framework for identification and quantification of potential degradation products.
ANSI/AMMI/ISO 10993–14:2001/(R) 2011, Biological evaluation of
medical devices—Part 14: Identification and quantification of degradation products form ceramics.
ISO TS 10993–19 First edition 2006–06–01 Biological evaluation of
medical devices—Part 19: Physio-chemical, morphological and topographical characterization of materials.
ISO 10993–9 Second edition 2009–12–15 Biological evaluation of
medical devices—Part 9: Framework for identification and quantification of potential degradation products.
ISO 10993–13 Second edition 2010–06–15, Biological evaluation of
medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices.
ISO 10993–14 First edition 2001–11–15, Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics.
ISO 10993–16 Second edition 2010–02–15, Biological evaluation of
medical devices—Part 16: Toxicokinetic study design for degradation products and leachables.
ANSI/AAMI/ISO TIR 10993–19:2006 Biological evaluation of medical
devices—Part 19: Physicochemical, morphological, and topographical characterization of materials.
ANSI/AAMI/ISO 10993–10:2010/(R) 2014 Biological evaluation of
medical devices—Part 10: Tests for irritation and skin sensitization.
ISO 10993–10 Third Edition 2010–08–01 Biological evaluation of
medical devices—Part 10: Tests for irritation and skin sensitization.
ISO 10993–3:2014 Third edition 2014–10–1 Biological evaluation of
medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and
reproductive toxicity.
ISO 10993–11 Second edition 2006–08–15 Biological evaluation of
medical devices—Part 11: Tests for systemic toxicity.
ISO 10993–06 Second edition 2007–04–15 Biological evaluation of
medical devices—Part 6: Tests for local effects after implantation.
ANSI/AAMI/ISO 10993–16:2010/(R) 2014, Biological evaluation of
medical devices—Part 16: Toxicokinetic study design for degradation products and leachables from medical devices.
ASTM F895–11 Standard Test Method for Agar Diffusion Cell Culture
Screening for Cytotoxicity.
ANSI/AAMI/ISO 10993–13:2010/(R) 2014 Biological evaluation of
medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices.
ISO 10993–12 Fourth edition 2012–07–01 Biological evaluation of
medical devices—Part 12: Sample preparation and reference materials.
ASTM F749–13 Standard Practice for Evaluating Material Extracts by
Intracutaneous Injection in the Rabbit.
ANSI/AAMI/ISO 10993–12:2012 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials.
ASTM F720–13 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test.
ASTM F2148–13 Standard Practice for Evaluation of Delayed Contact
Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA).
ASTM F756–13 Standard Practice for Assessment of Hemolytic Properties of Materials.
ASTM F1904–14 Standard Practice for Testing the Biological Responses to Particles In Vivo.
ASTM F619–14 Standard Practice for Extraction of Medical Plastics ..
Reaffirmation, Extent of recognition, Relevant guidance.
USP 39–NF34:2016 <87> Biological Reactivity test, In Vitro—Direct
Contact Test.
USP 39–NF34:2016 <87> Biological Reactivity Test, In Vitro—Elution
Test.
USP 39–NF34: 2016 <88> Biological Reactivity Tests, In Vivo ............
USP 39–NF34: 2016 <88> Biological Reactivity Tests In Vivo, Classification of Plastics—Intracutaneous Test.
USP 39–NF34: 2016 <88> Biological Reactivity Tests In Vivo, Classification of Plastics—Systemic Injection Test.
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Relevant guidance.
Extent of recognition,
guidance.
Relevant
Extent of recognition,
guidance.
Relevant
Extent of recognition,
guidance.
Relevant
Relevant guidance.
Relevant guidance.
Extent of recognition,
guidance.
Relevant
Reaffirmation, Extent of recognition, Relevant guidance.
Extent of recognition, Relevant
guidance.
Withdrawn and replaced with
newer version.
Extent of recognition,
guidance.
Extent of recognition,
guidance.
Relevant guidance.
Relevant
Relevant
Extent of recognition, Relevant
guidance.
Reaffirmation, Extent of recognition, Relevant guidance.
Extent of recognition,
guidance.
Relevant
Extent of recognition, Relevant
guidance.
Extent of recognition, Relevant
guidance.
Extent of recognition, Relevant
guidance.
Extent of recognition, Relevant
guidance.
Extent of recognition, Relevant
guidance.
Extent of recognition, Relevant
guidance.
Extent of recognition, Relevant
guidance.
Withdrawn and replaced with a
newer version.
Withdrawn and replaced with a
newer version.
Change in title, Withdrawn and replaced with a newer version.
Withdrawn; See 2–231.
Withdrawn; See 2–231.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
2–220 .................
........................
2–221 .................
........................
2–222 .................
........................
2–223 .................
........................
2–225 .................
........................
Title of standard 1
Change
ISO 10993–1 Fourth edition 2009–10–15 Biological evaluation of
medical devices—Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)].
ANSI/AAMI/ISO 10993–2:2006/(R) 2014 Biological evaluation of medical devices—Part 2: Animal welfare requirements.
ISO 10993–2 Second edition 2006–07–15 Biological evaluation of
medical devices—Part 2: Animal welfare requirements.
ASTM F2901–13, Standard guide for selecting tests to evaluate potential neurotoxicity of medical devices.
ASTM F2567–06 (Reapproved 2010), Standard practice for testing for
classical complement activation in serum by solid materials.
Extent of recognition,
guidance.
Relevant
Extent of recognition,
guidance.
Extent of recognition,
guidance.
Relevant guidance.
Relevant
Relevant
Relevant guidance.
B. Sterility
14–477 ...............
1
2–232
USP 39–NF34:2016 <151> Pyrogen Test .............................................
Transferred to Biocompatibility;
Relevant guidance.
All standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries
In table 2, FDA provides the listing of
new entries and consensus standards
added as modifications to the list of
recognized standards under Recognition
List Number: 044.
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Title of standard 1
Recognition No.
Reference No. and Date
A. Biocompatibility
2–233 ......................
2–234 ......................
2–235 ......................
2–236 ......................
2–237 ......................
2–238 ......................
2–239 ......................
2–240 ......................
2–241 ......................
2–242 ......................
2–243 ......................
1
Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT).
Biological Evaluation of Medical Devices—Part 4: Selection of tests for interaction with blood [Including Amendment 1(2006)].
Biological Evaluation of Medical Devices—Part 4: Selection of tests for interaction with blood [Including Amendment 1(2006)].
Biological evaluation of medical devices—Part 17: Establishment of allowable
limits for leachable substances.
Biological evaluation of medical devices—Part 17: Establishment of allowable
limits for leachable substances.
Biological evaluation of medical devices—Part 18: Chemical characterization of
materials.
Biological evaluation of medical devices—Part 20: Principles and methods for
immunotoxicology testing of medical devices.
Biological evaluation of medical devices—Part 20: Principles and methods for
immunotoxicology testing of medical devices.
Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants.
Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants.
Biological evaluation of medical devices—Part 33: Guidance on tests to evaluate genotoxicity.
ANSI/AAMI/ISO 10993–4:2002/(R)2013
& A1:2006/(R)2013.
ISO 10994–4 Second edition 2002–10–
15 Amendment 1 2006–07–15.
ANSI/AAMI/ISO
10993–17:2002/
(R)2012.
ISO 10993–17 First edition 2002–12–
01.
ANSI/AAMI BE 83: 2006/(R)2011.
ANSI/AAMI/ISO TIR 10993–20:2006.
ISO/TS 10993–20 First edition 2006–
08–01.
ISO/TR 37137 First edition 2014–05–
15.
ANSI/AAMI/ISO TR 37137: 2014.
ISO/TR 10993–33:2015 First edition
2015–03–01.
All standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
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F2382–04 (Reapproved 2010).
FDA maintains the Agency’s current
list of FDA Recognized Consensus
Standards in a searchable database that
may be accessed directly at FDA’s
Internet site at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA
will incorporate the modifications and
revisions described in this notice into
the database and, upon publication in
the Federal Register, this recognition of
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consensus standards will be effective.
FDA will announce additional
modifications and revisions to the list of
recognized consensus standards, as
needed, in the Federal Register once a
year, or more often if necessary.
Beginning with Recognition List 033,
FDA no longer announces minor
revisions to the list of recognized
consensus standards such as technical
contact person, devices affected,
processes affected, Code of Federal
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Regulations citations, and product
codes.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to standards@
cdrh.fda.gov. To be properly considered,
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such recommendations should contain,
at a minimum, the following
information: (1) Title of the standard, (2)
any reference number and date, (3)
name and address of the national or
international standards development
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply, and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
Food and Drug Administration
[Docket No. FDA–2013–N–0190]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requirements
Under the Comprehensive Smokeless
Tobacco Health Education Act of 1986,
as Amended by the Family Smoking
Prevention and Tobacco Control Act
AGENCY:
VI. Electronic Access
Food and Drug Administration,
HHS.
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. The Center for Devices and
Radiological Health (CDRH) maintains a
site on the Internet for easy access to
information including text, graphics,
and files that you may download to a
personal computer with access to the
Internet. Updated on a regular basis, the
CDRH home page, https://www.fda.gov/
MedicalDevices, includes a link to
standards-related documents including
the guidance and the current list of
recognized standards. After publication
in the Federal Register, this notice
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 044’’ will be available at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. You may
access ‘‘Guidance on the Recognition
and Use of Consensus Standards,’’ and
the searchable database for ‘‘FDA
Recognized Consensus Standards’’ at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards.
Dated: July 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17570 Filed 7–25–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 25,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0671. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Requirements Under the
Comprehensive Smokeless Tobacco
Health Education Act of 1986, as
Amended by the Family Smoking
Prevention and Tobacco Control Act
(OMB Control Number 0910–0671)—
Extension
The Family Smoking Prevention and
Tobacco Control Act (the Tobacco
Control Act) was enacted on June 22,
VerDate Sep<11>2014
20:28 Jul 25, 2016
Jkt 238001
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
48813
2009, amending the Federal Food, Drug,
and Cosmetic Act and providing FDA
with the authority to regulate tobacco
products (Pub. L. 111–31; 123 Stat.
1776). Section 3 of the Comprehensive
Smokeless Tobacco Health Education
Act of 1986 (the Smokeless Tobacco
Act) (15 U.S.C. 4402), as amended by
section 204 of the Tobacco Control Act,
requires, among other things, that all
smokeless tobacco product packages
and advertisements bear one of four
required warning statements. Section
3(b)(3)(A) of the Smokeless Tobacco Act
requires that the warnings be displayed
on packaging and advertising for each
brand of smokeless tobacco ‘‘in
accordance with a plan submitted by the
tobacco product manufacturer, importer,
distributor, or retailer’’ to, and approved
by, FDA.
This information collection-the
submission to FDA of warning plans for
smokeless tobacco products is
statutorily mandated. The warning
plans will be reviewed by FDA, as
required by the Smokeless Tobacco Act,
to determine whether the companies’
plans for the equal distribution and
display of warning statements on
packaging and the quarterly rotation of
warning statements in advertising for
each brand of smokeless tobacco
products comply with section 3 of the
Smokeless Tobacco Act, as amended.
Based on the Federal Trade
Commission’s (FTC’s) previous
experience with the submission of
warning plans and FDA’s experience,
FDA estimates that there are 52
companies affected by this information
collection. To account for the entry of
new smokeless tobacco companies that
may be affected by this information
collection, FDA is conservatively
estimating the total number of annual
respondents to this collection of
information to be 100.
When the FTC requested an extension
of their approved warning plan
information collection in 2007, based on
over 20 years implementing the warning
plan requirements and taking into
account increased computerization and
improvements in electronic
communication, the FTC estimated
submitting an initial plan would take 60
hours. Based on FDA’s experience over
the past several years, FDA believes the
estimate of 60 hours to complete an
initial rotational plan continues to be
reasonable.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48809-48813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17570]
[[Page 48809]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 044
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
Modifications to the List of Recognized Standards, Recognition List
Number: 044 (Recognition List Number: 044), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit electronic or written comments concerning this document
at any time. These modifications to the list of recognized standards
are effective July 26, 2016.
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-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 044.'' 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. FDA will
consider any comments received in determining whether to amend the
current listing of modifications to the list of recognized standards,
Recognition List Number: 043.
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 Recognition List Number: 044 is available on
the Internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 044 modifications and other standards related
information. Submit written requests for a single hard copy of the
document entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 044'' to Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993. Send one
self-addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8149.
FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-
6287, standards@cdrh.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The
[[Page 48810]]
notice described how FDA would implement its standard recognition
program and provided the initial list of recognized standards.
Modifications to the initial list of recognized standards, as
published in the Federal Register, can be accessed at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language (HTML) and portable document format (PDF) versions of
the list of FDA Recognized Consensus Standards. Both versions are
publicly accessible at the Agency's Internet site. See section VI of
this document for electronic access information. Interested persons
should review the supplementary information sheet for the standard to
understand fully the extent to which FDA recognizes the standard.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 044
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions and other requirements for devices. FDA
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 044'' to identify these current
modifications.
In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.
Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
----------------------------------------------------------------------------------------------------------------
A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-93.................................. .............. ASTM F763-04 (Reapproved 2010) Extent of recognition,
Standard Practice for Short- Relevant guidance.
Term Screening of Implant
Materials.
2-94.................................. .............. ASTM F981-04 (Reapproved 2010) Extent of recognition,
Standard Practice for Relevant guidance.
Assessment of Compatibility
of Biomaterials for Surgical
Implants with Respect to
Effect of Materials on Muscle
and Bone.
2-114................................. .............. ASTM F1877-05 (Reapproved Extent of recognition,
2010) Standard Practice for Relevant guidance.
Characterization of Particles.
2-117................................. 2-226 ANSI/AAMI/ISO 10993-3:2014 Withdrawn and replaced
Biological evaluation of with newer version.
medical devices--Part 3:
Tests for genotoxicity,
carcinogenicity, and
reproductive toxicity.
2-118................................. .............. ANSI/AAMI/ISO 10993-11:2006/ Reaffirmation, Extent of
(R) 2014 Biological recognition, Relevant
evaluation of medical guidance.
devices--Part 11: Tests for
systemic toxicity.
2-119................................. .............. ASTM F813-07 (Reapproved 2012) Extent of recognition,
Standard Practice for Direct Relevant guidance.
Contact Cell Culture
Evaluation of Materials for
Medical Devices.
2-120................................. .............. ANSI/AAMI/ISO 10993-6:2007/(R) Reaffirmation, Extent of
2014 Biological evaluation of recognition, Relevant
medical devices--Part 6: guidance.
Tests for local effects after
implantation.
2-122................................. .............. ASTM F719-81 (Reapproved 2012) Extent of recognition,
Standard Practice for Testing Relevant guidance.
Biomaterials in Rabbits for
Primary Skin Irritation.
2-124................................. .............. ASTM F750-87 (Reapproved 2012) Extent of recognition,
Standard Practice for Relevant guidance.
Evaluating Material Extracts
By Systemic Injection in the
Mouse.
2-126................................. .............. ASTM F748-06 (Reapproved 2010) Extent of recognition,
Standard Practice for Relevant guidance.
Selecting Generic Biological
Test Methods for Materials
and Devices.
2-133................................. .............. ASTM F1408-97 (Reapproved Extent of recognition,
2013) Standard Practice for Relevant guidance.
Subcutaneous Screening Test
for Implant Materials.
2-134................................. .............. ASTM F2065-00 (Reapproved Extent of recognition,
2010) Standard Practice for Relevant guidance.
Testing for Alternative
Pathway Complement Activation
in Serum by Solid Materials.
2-136................................. .............. ASTM E1262-88 (Reapproved Extent of recognition,
2013) Standard Guide for Relevant guidance.
Performance of Chinese
Hamster Ovary Cell/
Hypoxanthine Guanine
Phosphoribosyl Transferase
Gene Mutation Assay.
2-141................................. .............. ASTM F1984-99 (Reapproved Extent of recognition,
2013) Standard Practice for Relevant guidance.
Testing for Whole Complement
Activation in Serum by Solid
Materials.
2-142................................. 2-227 ASTM F1983-14 Standard Withdrawn and replaced
Practice for Assessment of with newer version.
Selected Tissue Effects of
Absorbable Biomaterials for
Implant Applications.
2-145................................. .............. ASTM F1439-03 (Reapproved Extent of recognition,
2013) Standard Guide for Relevant guidance.
Performance of Lifetime
Bioassay for the Tumorigenic
Potential of Implant
Materials.
2-153................................. .............. ANSI/AAMI/ISO 10993-5:2009/(R) Extent of recognition,
2014 Biological evaluation of Relevant guidance.
medical devices--Part 5:
Tests for in vitro
cytotoxicity.
2-155................................. .............. ASTM F2147-01 (Reapproved Extent of recognition,
2010) Standard Practice for Relevant guidance.
Guinea Pig: Split Adjuvant
and Closed Patch Testing for
Contact Allergens.
2-156................................. .............. ANSI/AAMI 10993-1:2009/(R) Extent of recognition,
2013 Biological evaluation of Relevant guidance.
medical devices--Part 1:
Evaluation and testing within
a risk management process
[Including: Technical
Corrigendum 1 (2010)].
2-162................................. .............. ASTM F1903-10 Standard Extent of recognition,
Practice for Testing For Relevant guidance.
Biological Responses to
Particles In Vitro.
[[Page 48811]]
2-163................................. .............. ANSI/AAMI/ISO 10993-9: 2009/ Reaffirmation, Extent of
(R) 2014 Biological recognition, Relevant
evaluation of medical guidance.
devices--Part 9: Framework
for identification and
quantification of potential
degradation products.
2-165................................. .............. ANSI/AMMI/ISO 10993-14:2001/ Relevant guidance.
(R) 2011, Biological
evaluation of medical
devices--Part 14:
Identification and
quantification of degradation
products form ceramics.
2-167................................. .............. ISO TS 10993-19 First edition Extent of recognition,
2006-06-01 Biological Relevant guidance.
evaluation of medical
devices--Part 19: Physio-
chemical, morphological and
topographical
characterization of materials.
2-168................................. .............. ISO 10993-9 Second edition Extent of recognition,
2009-12-15 Biological Relevant guidance.
evaluation of medical
devices--Part 9: Framework
for identification and
quantification of potential
degradation products.
2-169................................. .............. ISO 10993-13 Second edition Extent of recognition,
2010-06-15, Biological Relevant guidance.
evaluation of medical
devices--Part 13:
Identification and
quantification of degradation
products from polymeric
medical devices.
2-170................................. .............. ISO 10993-14 First edition Relevant guidance.
2001-11-15, Biological
evaluation of medical
devices--Part 14:
Identification and
quantification of degradation
products from ceramics.
2-171................................. .............. ISO 10993-16 Second edition Relevant guidance.
2010-02-15, Biological
evaluation of medical
devices--Part 16:
Toxicokinetic study design
for degradation products and
leachables.
2-172................................. .............. ANSI/AAMI/ISO TIR 10993- Extent of recognition,
19:2006 Biological evaluation Relevant guidance.
of medical devices--Part 19:
Physicochemical,
morphological, and
topographical
characterization of materials.
2-173................................. .............. ANSI/AAMI/ISO 10993-10:2010/ Reaffirmation, Extent of
(R) 2014 Biological recognition, Relevant
evaluation of medical guidance.
devices--Part 10: Tests for
irritation and skin
sensitization.
2-174................................. .............. ISO 10993-10 Third Edition Extent of recognition,
2010-08-01 Biological Relevant guidance.
evaluation of medical
devices--Part 10: Tests for
irritation and skin
sensitization.
2-175................................. 2-228 ISO 10993-3:2014 Third edition Withdrawn and replaced
2014-10-1 Biological with newer version.
evaluation of medical
devices--Part 3: Tests for
genotoxicity,
carcinogenicity, and
reproductive toxicity.
2-176................................. .............. ISO 10993-11 Second edition Extent of recognition,
2006-08-15 Biological Relevant guidance.
evaluation of medical
devices--Part 11: Tests for
systemic toxicity.
2-177................................. .............. ISO 10993-06 Second edition Extent of recognition,
2007-04-15 Biological Relevant guidance.
evaluation of medical
devices--Part 6: Tests for
local effects after
implantation.
2-180................................. .............. ANSI/AAMI/ISO 10993-16:2010/ Relevant guidance.
(R) 2014, Biological
evaluation of medical
devices--Part 16:
Toxicokinetic study design
for degradation products and
leachables from medical
devices.
2-189................................. .............. ASTM F895-11 Standard Test Extent of recognition,
Method for Agar Diffusion Relevant guidance.
Cell Culture Screening for
Cytotoxicity.
2-190................................. .............. ANSI/AAMI/ISO 10993-13:2010/ Reaffirmation, Extent of
(R) 2014 Biological recognition, Relevant
evaluation of medical guidance.
devices--Part 13:
Identification and
quantification of degradation
products from polymeric
medical devices.
2-191................................. .............. ISO 10993-12 Fourth edition Extent of recognition,
2012-07-01 Biological Relevant guidance.
evaluation of medical
devices--Part 12: Sample
preparation and reference
materials.
2-197................................. .............. ASTM F749-13 Standard Practice Extent of recognition,
for Evaluating Material Relevant guidance.
Extracts by Intracutaneous
Injection in the Rabbit.
2-198................................. .............. ANSI/AAMI/ISO 10993-12:2012 Extent of recognition,
Biological evaluation of Relevant guidance.
medical devices--Part 12:
Sample preparation and
reference materials.
2-204................................. .............. ASTM F720-13 Standard Practice Extent of recognition,
for Testing Guinea Pigs for Relevant guidance.
Contact Allergens: Guinea Pig
Maximization Test.
2-206................................. .............. ASTM F2148-13 Standard Extent of recognition,
Practice for Evaluation of Relevant guidance.
Delayed Contact
Hypersensitivity Using the
Murine Local Lymph Node Assay
(LLNA).
2-207................................. .............. ASTM F756-13 Standard Practice Extent of recognition,
for Assessment of Hemolytic Relevant guidance.
Properties of Materials.
2-213................................. .............. ASTM F1904-14 Standard Extent of recognition,
Practice for Testing the Relevant guidance.
Biological Responses to
Particles In Vivo.
2-214................................. .............. ASTM F619-14 Standard Practice Extent of recognition,
for Extraction of Medical Relevant guidance.
Plastics.
2-215................................. 2-229 USP 39-NF34:2016 <87> Withdrawn and replaced
Biological Reactivity test, with a newer version.
In Vitro--Direct Contact Test.
2-216................................. 2-230 USP 39-NF34:2016 <87> Withdrawn and replaced
Biological Reactivity Test, with a newer version.
In Vitro--Elution Test.
2-217................................. 2-231 USP 39-NF34: 2016 <88> Change in title,
Biological Reactivity Tests, Withdrawn and replaced
In Vivo. with a newer version.
2-218................................. .............. USP 39-NF34: 2016 <88> Withdrawn; See 2-231.
Biological Reactivity Tests
In Vivo, Classification of
Plastics--Intracutaneous Test.
2-219................................. .............. USP 39-NF34: 2016 <88> Withdrawn; See 2-231.
Biological Reactivity Tests
In Vivo, Classification of
Plastics--Systemic Injection
Test.
[[Page 48812]]
2-220................................. .............. ISO 10993-1 Fourth edition Extent of recognition,
2009-10-15 Biological Relevant guidance.
evaluation of medical
devices--Part 1: Evaluation
and testing within a risk
management process
[Including: Technical
Corrigendum 1 (2010)].
2-221................................. .............. ANSI/AAMI/ISO 10993-2:2006/(R) Extent of recognition,
2014 Biological evaluation of Relevant guidance.
medical devices--Part 2:
Animal welfare requirements.
2-222................................. .............. ISO 10993-2 Second edition Extent of recognition,
2006-07-15 Biological Relevant guidance.
evaluation of medical
devices--Part 2: Animal
welfare requirements.
2-223................................. .............. ASTM F2901-13, Standard guide Relevant guidance.
for selecting tests to
evaluate potential
neurotoxicity of medical
devices.
2-225................................. .............. ASTM F2567-06 (Reapproved Relevant guidance.
2010), Standard practice for
testing for classical
complement activation in
serum by solid materials.
----------------------------------------------------------------------------------------------------------------
B. Sterility
----------------------------------------------------------------------------------------------------------------
14-477................................ 2-232 USP 39-NF34:2016 <151> Pyrogen Transferred to
Test. Biocompatibility;
Relevant guidance.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries
In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 044.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No.
Recognition No. Title of standard \1\ and Date
------------------------------------------------------------------------
A. Biocompatibility
------------------------------------------------------------------------
2-233......................... Standard Test Method F2382-04
for Assessment of (Reapproved
Intravascular Medical 2010).
Device Materials on
Partial
Thromboplastin Time
(PTT).
2-234......................... Biological Evaluation ANSI/AAMI/ISO
of Medical Devices-- 10993-4:2002/
Part 4: Selection of (R)2013 &
tests for interaction A1:2006/
with blood [Including (R)2013.
Amendment 1(2006)].
2-235......................... Biological Evaluation ISO 10994-4
of Medical Devices-- Second edition
Part 4: Selection of 2002-10-15
tests for interaction Amendment 1
with blood [Including 2006-07-15.
Amendment 1(2006)].
2-236......................... Biological evaluation ANSI/AAMI/ISO
of medical devices-- 10993-17:2002/
Part 17: (R)2012.
Establishment of
allowable limits for
leachable substances.
2-237......................... Biological evaluation ISO 10993-17
of medical devices-- First edition
Part 17: 2002-12-01.
Establishment of
allowable limits for
leachable substances.
2-238......................... Biological evaluation ANSI/AAMI BE 83:
of medical devices-- 2006/(R)2011.
Part 18: Chemical
characterization of
materials.
2-239......................... Biological evaluation ANSI/AAMI/ISO
of medical devices-- TIR 10993-
Part 20: Principles 20:2006.
and methods for
immunotoxicology
testing of medical
devices.
2-240......................... Biological evaluation ISO/TS 10993-20
of medical devices-- First edition
Part 20: Principles 2006-08-01.
and methods for
immunotoxicology
testing of medical
devices.
2-241......................... Cardiovascular ISO/TR 37137
biological evaluation First edition
of medical devices-- 2014-05-15.
Guidance for
absorbable implants.
2-242......................... Cardiovascular ANSI/AAMI/ISO TR
biological evaluation 37137: 2014.
of medical devices--
Guidance for
absorbable implants.
2-243......................... Biological evaluation ISO/TR 10993-
of medical devices-- 33:2015 First
Part 33: Guidance on edition 2015-03-
tests to evaluate 01.
genotoxicity.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
IV. List of Recognized Standards
FDA maintains the Agency's current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed directly at
FDA's Internet site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and revisions described in this notice into the database and, upon
publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
Beginning with Recognition List 033, FDA no longer announces minor
revisions to the list of recognized consensus standards such as
technical contact person, devices affected, processes affected, Code of
Federal Regulations citations, and product codes.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
standards@cdrh.fda.gov. To be properly considered,
[[Page 48813]]
such recommendations should contain, at a minimum, the following
information: (1) Title of the standard, (2) any reference number and
date, (3) name and address of the national or international standards
development organization, (4) a proposed list of devices for which a
declaration of conformity to this standard should routinely apply, and
(5) a brief identification of the testing or performance or other
characteristics of the device(s) that would be addressed by a
declaration of conformity.
VI. Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. The Center for Devices and
Radiological Health (CDRH) maintains a site on the Internet for easy
access to information including text, graphics, and files that you may
download to a personal computer with access to the Internet. Updated on
a regular basis, the CDRH home page, https://www.fda.gov/MedicalDevices,
includes a link to standards-related documents including the guidance
and the current list of recognized standards. After publication in the
Federal Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 044'' will be available
at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition
and Use of Consensus Standards,'' and the searchable database for ``FDA
Recognized Consensus Standards'' at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
Dated: July 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17570 Filed 7-25-16; 8:45 am]
BILLING CODE 4164-01-P
