[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Notices]
[Pages 24711-24718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10562]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451] (formerly Docket No. 2004N-0226)
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 023
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) 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: 023'' (Recognition List Number: 023), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit written or electronic comments concerning this document
at any time. See section VII of this document for the effective date of
the recognition of standards announced in this document.
ADDRESSES: Submit written requests for single copies of
``Modifications to the List of Recognized Standards, Recognition List
Number: 023'' to the Division of Small Manufacturers, International,
and Consumer Assistance, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66,
[[Page 24712]]
rm. 4613, Silver Spring, MD 20993-0002. Send two self-addressed
adhesive labels to assist that office in processing your requests, or
fax your request to 301-847-8149. Submit written comments concerning
this document, or recommendations for additional standards for
recognition, to the contact person (see FOR FURTHER INFORMATION
CONTACT). Submit electronic comments by e-mail: [email protected].
This document may also be accessed on FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. 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: 023 modifications and other
standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301-
796-6574.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the 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 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, are identified in table 1 of this
document.
Table 1.--Previous Publications of Standard Recognition Lists
February 25, 1998 (63 FR 9561) May 27, 2005 (70 FR 30756)
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October 16, 1998 (63 FR 55617) November 8, 2005 (70 FR 67713)
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July 12, 1999 (64 FR 37546) March 31, 2006 (71 FR 16313)
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November 15, 2000 (65 FR 69022) June 23, 2006 (71 FR 36121)
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May 7, 2001 (66 FR 23032) November 3, 2006 (71 FR 64718)
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January 14, 2002 (67 FR 1774) May 21, 2007 (72 FR 28500)
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October 2, 2002 (67 FR 61893) September 12, 2007 (72 FR 52142)
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April 28, 2003 (68 FR 22391) December 19, 2007 (72 FR 71924)
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March 8, 2004 (69 FR 10712) September 9, 2008 (73 FR 52358)
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June 18, 2004 (69 FR 34176) March, 18, 2009 (74 FR 11586)
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October 4, 2004 (69 FR 59240) September 8, 2009 (74 FR 46203)
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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: 023
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the agency will recognize for
use in satisfying premarket reviews 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: 023'' to identify these current
modifications.
In table 2 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others; (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 of this document, FDA lists modifications the agency
is making that involve the initial addition of standards not previously
recognized by FDA.
Table 2.--Modifications to the List of Recognized Standards
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Replacement
Old Recognition No. Recognition No. Standard Change
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A. Biocompatibility
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2-64 2-153 ANSI/AAMI/ISO 10993-5:2009 Biological Withdrawn and replaced
Evaluation of Medical Devices--Part 5: with newer version
Tests for in vitro Cytotoxicity
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2-67 2-154 ASTM F756--08 Standard Practice for Withdrawn and replaced
Assessment of Hemolytic Properties of with newer version
Materials
----------------------------------------------------------------------------------------------------------------
2-82 2-155 ASTM F2147-01 (Reapproved 2006) Standard Withdrawn and replaced
Practice for Guinea Pig: Split Adjuvant and with newer version
Closed Patch Testing for Contact Allergens
----------------------------------------------------------------------------------------------------------------
2-87 ................... ISO 10993-10:2002 Biological Evaluation of Title, Extent of
Medical Devices--Part 10: Tests for recognition, and
Irritation and Delayed-Type Relevant guidance
Hypersensitivity
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2-93 ................... ASTM F 763--04 Standard Practice for Short- Extent of recognition
Term Screening of Implant Materials
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[[Page 24713]]
2-94 ................... ASTM F 981--04 Standard Practice for Extent of recognition
Assessment of Compatibility of Biomaterials
for Surgical Implants with Respect to
Effect of Materials on Muscle and Bone
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2-96 ................... ASTM F 1903--98 (Reapproved 2003) Standard Title and Extent of
Practice for Testing For Biological recognition
Responses to Particles in vitro
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2-98 ................... ANSI/ AAMI/ ISO 10993-1:2003 Biological Title, Extent of
Evaluation of Medical Devices--Part 1: recognition, and
Evaluation and Testing Relevant guidance
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2-100 ................... ASTM E 1372--95 (Reapproved 2003) Standard Title and Extent of
Test Method for Conducting a 90-Day Oral recognition
Toxicity Study in Rats
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2-108 ................... ASTM F 1905--98 (Reapproved 2003) Standard Title and Extent of
Practice For Selecting Tests for recognition
Determining the Propensity of Materials to
Cause Immunotoxicity
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2-114 ................... ASTM F 1877--05 Standard Practice for Extent of recognition
Characterization of Particles
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2-115 ................... ASTM F 895--84 (Reapproved 2006) Standard Title, Extent of
Test Method for Agar Diffusion Cell Culture recognition, and
Screening for Cytotoxicity Relevant guidance
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2-117 ................... ANSI/AAMI/ISO 10993-3:2003 Biological Title, Extent of
Evaluation of Medical Devices--Part 3: recognition, and
Tests for Genotoxicity, Carcinogenicity, contact person
and Reproductive Toxicity
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2-118 ................... ANSI/AAMI/ISO 10993-11:2006 Biological Title, Extent of
Evaluation of Medical Devices--Part 11: recognition, and
Tests for Systemic Toxicity Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-119 ................... ASTM F813-07 Standard Practice for Direct Extent of recognition
Contact Cell Culture Evaluation of
Materials for Medical Devices
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2-120 ................... ANSI/AAMI/ISO 10993-6:2007 Biological Title and Extent of
Evaluation of Medical Devices--Part 6: recognition
Tests for Local Effects after Implantation
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2-122 ................... ASTM F 719-81 (Reapproved 2007)e Standard Title, Extent of
Practice for Testing Biomaterials in recognition, and
Rabbits for Primary Skin Irritation Relevant guidance
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2-123 ................... ASTM F 720-81 (Reapproved 2007) Standard Title, Extent of
Practice for Testing Guinea Pigs for recognition, and
Contact Allergens: Guinea Pig Maximization Relevant guidance
Test
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2-124 ................... ASTM F 750-87 (Reapproved 2007)e Standard Title, Extent of
Practice for Evaluating Material Extracts recognition, and
by Systemic Injection in the Mouse Relevant guidance
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2-125 ................... ASTM F749-98 (Reapproved 2007)e1 Standard Title, Extent of
Practice for Evaluating Material Extracts recognition, and
by Intracutaneous Injection in the Rabbit Relevant guidance
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2-126 ................... ASTM F748-06 Standard Practice for Selecting Extent of recognition
Generic Biological Test Methods for and Relevant guidance
Materials and Devices
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2-133 ................... ASTM F1408-97 (Reapproved 2008) Standard Extent of recognition
Practice for Subcutaneous Screening Test
for Implant Materials
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2-134 ................... ASTM F2065-00 (Reapproved 2006) Standard Extent of recognition
Practice for Testing for Alternative
Pathway Complement Activation in Serum by
Solid Materials
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2-135 ................... ANSI/ AAMI/ ISO 10993-12:2007 Biological Title, Extent of
Evaluation of Medical Devices--Part 12: recognition, and
Sample Preparation and Reference Materials Relevant guidance
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2-136 ................... ASTM E1262-88 (Reapproved 2008) Standard Title, Extent of
Guide for Performance of Chinese Hamster recognition, and
Ovary Cell/Hypoxanthine Guanine Relevant guidance
Phosphoribosyl Transferase Gene Mutation
Assay
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2-137 ................... ASTM E1263-97 (Reapproved 2008) Standard Extent of recognition
Guide for Conduct of Micronucleus Assays in
Mammalian Bone Marrow Erythrocytes
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2-138 ................... ASTM E1280-97 (Reapproved 2008) Standard Extent of recognition
Guide for Performing the Mouse Lymphoma and Relevant guidance
Assay for Mammalian Cell Mutagenicity
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2-139 ................... ASTM E1397-91 (Reapproved 2008) Standard Extent of recognition
Practice for the In Vitro Rat Hepatocyte
DNA Repair Assay
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[[Page 24714]]
2-140 ................... ASTM E1398-91 (Reapproved 2008) Standard Extent of recognition
Practice for the In Vivo Rat Hepatocyte DNA
Repair Assay
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2-141 ................... ASTM F1984-99 (Reapproved 2008) Standard Extent of recognition,
Practice for Testing for Whole Complement Relevant guidance and
Activation in Serum by Solid Materials Contact person
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2-142 ................... ASTM F1983-99 (Reapproved 2008) Standard Extent of recognition
Practice for Assessment of Compatibility of
Absorbable/Resorbable Biomaterials for
Implant Applications
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2-143 ................... ASTM F1904-98 (Reapproved 2008) Standard Extent of recognition
Practice for Testing the Biological
Responses to Particles in vivo
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2-144 ................... ASTM F619-03 (Reapproved 2008) Standard Extent of recognition
Practice for Extraction of Medical Plastics and Relevant guidance
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2-145 ................... ASTM F1439-03 (Reapproved 2008) Standard Extent of recognition
Guide for Performance of Lifetime Bioassay
for the Tumorigenic Potential of Implant
Materials
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2-146 ................... ASTM F2148-07e1 Standard Practice for Extent of recognition
Evaluation of Delayed Contact and Relevant guidance
Hypersensitivity Using the Murine Local
Lymph Node Assay (LLNA)
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2-147 ................... USP 32-NF26 Biological Tests <87> 2009 Extent of recognition
Biological Reactivity Test, In Vitro-- and Relevant guidance
Direct Contact Test
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2-148 ................... USP 32-NF26 Biological Tests <87> Biological Extent of recognition
Reactivity Test, In Vitro--Elution Test and Relevant guidance
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2-149 ................... USP 32-NF26 Biological Tests <88> Biological Extent of recognition
Reactivity Tests, In Vivo, Procedure-- and Relevant guidance
Preparation of Sample
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2-150 ................... USP 32-NF26 Biological Tests <88> Biological Extent of recognition
Reactivity Tests, In Vivo, Classification and Relevant guidance
of Plastics--Intracutaneous Test
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2-151 ................... USP 32-NF26 Biological Tests <88> Biological Extent of recognition
Reactivity Tests, In Vivo, Classification and Relevant guidance
of Plastics--Systemic Injection Test
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2-152 ................... ISO 10993-10:2002/Amd.1:2006(E) Biological Extent of recognition
Evaluation of Medical Devices--Part 10: and Relevant guidance
Tests for Irritation and Delayed-Type
Hypersensitivity AMENDMENT 1
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B. Cardiology
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3-2 3-72 ANSI/AAMI EC53:1995/(R) 2008 ECG Cables and Withdrawn and replaced
Leadwires with newer version
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3-29 ................... IEC 60601-2-30 (1999-12) Medical Electrical Withdrawn
Equipment, Part 2: Particular Requirements
for the Safety, Including Essential
Performance, of Automatic Cycling Non-
Invasive Blood Pressure Monitoring
Equipment
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3-45 3-73 ANSI/AAMI/ISO EC57:1998/(R)2008 Testing and Withdrawn and replaced
Reporting Performance Results of Cardiac with newer version
Rhythm and ST-Segment Measurement
Algorithms
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3-49 3-74 ASTM F2079-02 (Reapproved 2008) Standard Withdrawn and replaced
Test Method for Measuring Intrinsic Elastic with newer version
Recoil of Balloon-Expandable Stents\1\
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3-50 ................... AAMI/ANSI DF2-1996 (Revision of ANSI/AAMI Withdrawn
DF2-1989) Cardiac Defibrillator Devices
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3-51 ................... AAMI /ANSI DF-39-1993 Automatic External Withdrawn
Defibrillators and Remote-Control
Defibrillators
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3-53 3-75 ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI Withdrawn and replaced
SP10:2002/A1:2003/(R)2008 & ANSI/AAMI with newer version
SP10:2002/A2:2006/(R)2008, ANSI/AAMI
SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/
A1:2003/(R)2008 & ANSI/AAMI SP10:2002/
A2:2006/(R)2008 Manual, Electronic, or
Automated Sphygmomanometers
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[[Page 24715]]
3-63 ................... ISO 11318:2002 Cardiac Defibrillators-- Contact person
Connector Assembly DF-1 for Implantable
Defibrillators--Dimensions and Test
Requirements
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3-67 3-76 ASTM F2129-08 Standard Test Method for Withdrawn and replaced
Conducting Cyclic Potentiodynamic with newer version
Polarization Measurements to Determine the
Corrosion Susceptibility of Small Implant
Devices
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3-70 ................... AAMI/ANSI SP10:2002/A1:2003--Amendment 1 to Withdrawn
ANSI/AAMI SP10:2002 Manual, Electronic, or
Automated Sphygmomanometers
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3-71 ................... AAMI/ANSI SP10:2002/A2:2006--Amendment 2 to Withdrawn
ANSI/AAMI SP10:2002 Manual, Electronic, or
Automated Sphygmomanometers
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C. Dental/ENT
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4-78 4-180 ISO 9168:2009 Dentistry--Hose Connectors for Withdrawn and replaced
Air Driven Dental Handpieces with newer version
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4-87 ................... ADA/ANSI ADA Specification No. 69 - Dental Reaffirmation
Ceramic:1999
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4-91 ................... ADA/ANSI ADA Specification No. 80 - Dental Reaffirmation
Material-Determination of Color
Stability:2001
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4-99 4-181 ISO 4049:2009 Dentistry-Polymer-Based Withdrawn and replaced
Filling, Restorative and Luting Materials with newer version
----------------------------------------------------------------------------------------------------------------
4-117 ................... ADA/ANSI Specification No. 12 - Denture Base Reaffirmation
Polymers:2002
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4-119 ................... ADA/ANSI Specification No. 82 - Dental Reaffirmation
Reversible/Irreversible Hydrocolloid
Impression Material Systems: 1998/
Reaffirmed 2003
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4-120 4-182 ISO 10139-2:2009 Dentistry--Soft Lining Withdrawn and replaced
Materials for Removable Dentures--Part 2: with newer version
Materials for Long-Term Use
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4-160 ................... ANSI/ASA S3.1-1999 (R 2003) Maximum Reaffirmation
Permissible Ambient Noise Levels for
Audiometric Test Rooms
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4-161 4-183 ANSI/ASA S3.2-2009 Method for Measuring the Withdrawn and replaced
Intelligibility of Speech Over with newer version
Communication Systems
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4-164 ................... ANSI/ASA S3.7-1995 (R 2003) Method for Reaffirmation
Coupler Calibration of Earphones
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4-166 ................... ANSI/ASA S3.20-1995 (R2003) Bioacoustical Reaffirmation
Terminology
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4-167 ................... ANSI/ASA S3.21-2004 Methods for Manual Pure- Reaffirmation
Tone threshold Audiometry
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4-168 4-184 ANSI/ASA S3.25-2009 Occluded Ear Simulator Withdrawn and replaced
with newer version
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4-174 4-185 ANSI/ASA S3.45-2009 Procedures for Testing Withdrawn and replaced
Basic Vestibular Function with newer version
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4-176 4-186 ANSI/ASA S12.2-2008 Criteria for Evaluating Withdrawn and replaced
Room Noise with newer version
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D. General
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5-18 5-51 ASTM D-4332-01 (Reapproved 2006) Standard Withdrawn and replaced
Practice for Conditioning Containers, with newer version
Packages, or Packaging Components for
Testing
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5-29 ................... AAMI/ANSI HE74-2001/ Human Factors Design Reaffirmation
Process for Medical Devices
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E. In Vitro Diagnostics
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7-35 7-205 CLSI H47-A2 One-Stage Prothrombin Time (PT) Withdrawn and replaced
Test and Activated Partial Thromboplastin with newer version
Time (APTT) Test
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[[Page 24716]]
7-42 7-206 CLSI I/LA20-A2 Analytical Performance Withdrawn and replaced
Characteristics and Clinical Utility of with newer version
Immunological Assays for Human
Immunoglobulin E (IgE) Antibodies and
Defined Allergen Specificities
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7-97 7-207 CLSI GP16-A3 Urinalysis Withdrawn and replaced
with newer version
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7-187 7-208 CLSI M44-S2 Zone Diameter Interpretive Withdrawn and replaced
Standards, Corresponding Minimal Inhibitory with newer version
Concentration (MIC) Interpretive
Breakpoints, and Quality Control Limits for
Antifungal Disk Diffusion Susceptibility
Testing of Yeasts
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7-37 ................... NCCLS I/LA06-A Detection and Quantitation of Withdrawn
Rubella IgG Antibody: Evaluation and
Performance Criteria for Multiple Component
Test Products, Specimen Handling, and Use
of Test Products in the Clinical Laboratory
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F. Materials
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8-104 8-189 ASTM F 1108--04 (Reapproved 2009) Standard Withdrawn and replaced
Specification for Titanium-6Aluminum- with newer version
4Vanadium Alloy Castings for Surgical
Implants (UNS R56406)
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8-145 8-190 ASTM F 90-09 Standard Specification for Withdrawn and replaced
Wrought Cobalt-20Chromium-15Tungsten- with newer version
10Nickel Alloy for Surgical Implant
Applications (UNS R30605)
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G. Physical Medicine
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16-19 16-162 ISO 7176-4:2008 Wheelchairs--Part 4: Energy Withdrawn and replaced
Consumption of Electric Wheelchairs and with newer version
Scooters for Determination of Theoretical
Distance Range
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16-20 16-163 ISO 7176-5:2008 Wheelchairs--Part 5: Withdrawn and replaced
Determination of Dimensions, Mass and with newer version
Manoeuvring Space
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16-23 16-164 ISO 7176-10:2008 Wheelchairs--Part 10: Withdrawn and replaced
Determination of Obstacle-Climbing Ability with newer version
of Electrically Powered Wheelchairs
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16-26 16-165 ISO 7176-14:2008 Wheelchairs--Part 14 Power Withdrawn and replaced
and Control Systems for Electrically with newer version
Powered Wheelchairs and Scooters--
Requirements and Test Methods
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H. Sterility
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14-117 ................... ANSI/AAMI ST35:2003 Handling and Biological Withdrawn
Decontamination of Reusable Medical Devices
in Health Care Facilities and in
Nonclinical Settings
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14-263 14-280 ANSI/AAMI ST79:2006 and A1:2008, A2:2009 Withdrawn and replaced
(Consolidated Text) Comprehensive Guide to with newer version
Steam Sterilization and Sterility Assurance
in Health Care Facilities
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14-256 14-286 ASTM F2095-07e1 Standard Test Methods for Withdrawn and replaced
Pressure Decay Leak Test for Flexible with newer version
Packages With and Without Restraining
Plates
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14-255 14-281 ASTM F17-08 Standard Terminology Relating to Withdrawn and replaced
Flexible Barrier Packaging\1\ with newer version
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14-245 14-282 ASTM F2338-09 Standard Test Method for Withdrawn and replaced
Nondestructive Detection of Leaks in with newer version
Packages by Vacuum Decay Method\1\
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14-237 14-283 ASTM F 88/F 88M--09 Standard Test Method for Withdrawn and replaced
Seal Strength of Flexible Barrier with newer version
Materials\1\
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14-199 14-284 ASTM D4169-08 Standard Practice for Withdrawn and replaced
Performance Testing of Shipping Containers with newer version
and Systems\1\
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14-228 ................... ANSI/AAMI/ISO 11135-1:2007 Sterilization of Guidance
Health Care Products - Ethylene oxide -
Part 1: Requirements for Development,
Validation, and Routine Control of a
Sterilization Process for Medical Devices
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[[Page 24717]]
14-70 14-285 ANSI/AAMI/ISO 14161:2009 Sterilization of Withdrawn and replaced
Health Care Products - Biological with newer version
Indicators - Guidance for the Selection,
Use and Interpretation of Results
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I. Tissue Engineering
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15-6 15-16 ASTM F2450-09 Standard Guide for Assessing Withdrawn and replaced
Microstructure of Polymeric Scaffolds for with newer version
Use in Tissue Engineered Medical
Products\1\
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15-9 15-17 ASTM F2311-08 Standard Guide for Withdrawn and replaced
Classification of Therapeutic Skin with newer version
Substitutes\1\
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15-13 15-18 ASTM F2212-09 Standard Guide for Withdrawn and replaced
Characterization of Type I Collagen as with newer version
Starting Material for Surgical Implants and
Substrates for Tissue Engineered Medical
Products (TEMPs)\1\
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III. Listing of New Entries
In table 3 of this document, FDA provides the listing of new
entries and consensus standards added as modifications to the list of
recognized standards under Recognition List Number: 023.
Table 3.--New Entries to the List of Recognized Standards
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Reference No. &
Recognition No. Title of Standard Date
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A. Cardiology
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3-77 Active Implantable Medical Devices-- ANSI/AAMI
Electromagnetic Compatibility--EMC PC69:2007
Test Protocols for Implantable
Cardiac Pacemakers and Implantable
Cardioverter Defibrillators
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B. In Vitro Diagnostics
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7-209 Performance Metrics for Continuous POCT 05-A
Interstitial Glucose Monitoring
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C. Orthopedics
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11-219 Standard Specification for ASTM F 2026-08
Polyetheretherketone (PEEK) Polymers
for Surgical Implant Applications
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D. Physical Medicine
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16-166 Wheelchairs--Requirements and Test ISO 7176-21:2009
Methods for Electromagnetic
Compatibility of Electrically
Powered Wheelchairs and Scooters,
and Battery Chargers
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E. Sterility
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14-286 Processing of Reusable Surgical ANSI/AAMI
Textiles for Use in Health Care ST65:2008
Facilities
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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 minor 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 minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (See FOR FURTHER INFORMATION CONTACT). To be
properly considered 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 devices 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. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal
[[Page 24718]]
computer with access to the Internet. Updated on a regular basis, the
CDRH home page includes the guidance as well as the current list of
recognized standards and other standards related documents. After
publication in the Federal Register, this notice announcing
``Modification to the List of Recognized Standards, Recognition List
Number: 023'' will be available on the CDRH home page. You may access
the CDRH home page at http://www.fda.gov/cdrh.
You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' through the hyperlink at http://www.fda.gov/cdrh/stdsprog.html.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/cdrh/fedregin.html.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. Two copies of any mailed comments are to be submitted,
except that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. 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: 023. These modifications
to the list or recognized standards are effective upon publication of
this notice in the Federal Register.
Dated: April 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10562 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S