[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]]
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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.
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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: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-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 http://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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
An electronic copy of Recognition List Number: 044 is available on
the Internet at http://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, [email protected].
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 http://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
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Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
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A. Biocompatibility
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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.
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B. Sterility
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14-477................................ 2-232 USP 39-NF34:2016 <151> Pyrogen Transferred to
Test. Biocompatibility;
Relevant guidance.
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\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
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Reference No.
Recognition No. Title of standard \1\ and Date
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A. Biocompatibility
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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.
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\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 http://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
[email protected]. 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, http://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 http://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 http://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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