
[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]               
[Page 24711-24718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my10-102]                         

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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.

-----------------------------------------------------------------------

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: standards@cdrh.fda.gov. 
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)
------------------------------------------------------------------------
October 16, 1998 (63 FR 55617)       November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
July 12, 1999 (64 FR 37546)          March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
November 15, 2000 (65 FR 69022)      June 23, 2006 (71 FR 36121)
------------------------------------------------------------------------
May 7, 2001 (66 FR 23032)            November 3, 2006 (71 FR 64718)
------------------------------------------------------------------------
January 14, 2002 (67 FR 1774)        May 21, 2007 (72 FR 28500)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893)        September 12, 2007 (72 FR 52142)
------------------------------------------------------------------------
April 28, 2003 (68 FR 22391)         December 19, 2007 (72 FR 71924)
------------------------------------------------------------------------
March 8, 2004 (69 FR 10712)          September 9, 2008 (73 FR 52358)
------------------------------------------------------------------------
June 18, 2004 (69 FR 34176)          March, 18, 2009 (74 FR 11586)
------------------------------------------------------------------------
October 4, 2004 (69 FR 59240)        September 8, 2009 (74 FR 46203)
------------------------------------------------------------------------

    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
----------------------------------------------------------------------------------------------------------------
                          Replacement
 Old Recognition No.    Recognition No.                      Standard                             Change
----------------------------------------------------------------------------------------------------------------
A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
2-93                  ...................  ASTM F 763--04 Standard Practice for Short-   Extent of recognition
                                            Term Screening of Implant Materials
----------------------------------------------------------------------------------------------------------------

[[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
----------------------------------------------------------------------------------------------------------------
2-96                  ...................  ASTM F 1903--98 (Reapproved 2003) Standard    Title and Extent of
                                            Practice for Testing For Biological           recognition
                                            Responses to Particles in vitro
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
2-114                 ...................  ASTM F 1877--05 Standard Practice for         Extent of recognition
                                            Characterization of Particles
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
2-126                 ...................  ASTM F748-06 Standard Practice for Selecting  Extent of recognition
                                            Generic Biological Test Methods for           and Relevant guidance
                                            Materials and Devices
----------------------------------------------------------------------------------------------------------------
2-133                 ...................  ASTM F1408-97 (Reapproved 2008) Standard      Extent of recognition
                                            Practice for Subcutaneous Screening Test
                                            for Implant Materials
----------------------------------------------------------------------------------------------------------------
2-134                 ...................  ASTM F2065-00 (Reapproved 2006) Standard      Extent of recognition
                                            Practice for Testing for Alternative
                                            Pathway Complement Activation in Serum by
                                            Solid Materials
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
2-137                 ...................  ASTM E1263-97 (Reapproved 2008) Standard      Extent of recognition
                                            Guide for Conduct of Micronucleus Assays in
                                            Mammalian Bone Marrow Erythrocytes
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
2-139                 ...................  ASTM E1397-91 (Reapproved 2008) Standard      Extent of recognition
                                            Practice for the In Vitro Rat Hepatocyte
                                            DNA Repair Assay
----------------------------------------------------------------------------------------------------------------

[[Page 24714]]


2-140                 ...................  ASTM E1398-91 (Reapproved 2008) Standard      Extent of recognition
                                            Practice for the In Vivo Rat Hepatocyte DNA
                                            Repair Assay
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
2-142                 ...................  ASTM F1983-99 (Reapproved 2008) Standard      Extent of recognition
                                            Practice for Assessment of Compatibility of
                                            Absorbable/Resorbable Biomaterials for
                                            Implant Applications
----------------------------------------------------------------------------------------------------------------
2-143                 ...................  ASTM F1904-98 (Reapproved 2008) Standard      Extent of recognition
                                            Practice for Testing the Biological
                                            Responses to Particles in vivo
----------------------------------------------------------------------------------------------------------------
2-144                 ...................  ASTM F619-03 (Reapproved 2008) Standard       Extent of recognition
                                            Practice for Extraction of Medical Plastics   and Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-145                 ...................  ASTM F1439-03 (Reapproved 2008) Standard      Extent of recognition
                                            Guide for Performance of Lifetime Bioassay
                                            for the Tumorigenic Potential of Implant
                                            Materials
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
2-147                 ...................  USP 32-NF26 Biological Tests <87> 2009        Extent of recognition
                                            Biological Reactivity Test, In Vitro--        and Relevant guidance
                                            Direct Contact Test
----------------------------------------------------------------------------------------------------------------
2-148                 ...................  USP 32-NF26 Biological Tests <87> Biological  Extent of recognition
                                            Reactivity Test, In Vitro--Elution Test       and Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-149                 ...................  USP 32-NF26 Biological Tests <88> Biological  Extent of recognition
                                            Reactivity Tests, In Vivo, Procedure--        and Relevant guidance
                                            Preparation of Sample
----------------------------------------------------------------------------------------------------------------
2-150                 ...................  USP 32-NF26 Biological Tests <88> Biological  Extent of recognition
                                            Reactivity Tests, In Vivo, Classification     and Relevant guidance
                                            of Plastics--Intracutaneous Test
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
B. Cardiology
----------------------------------------------------------------------------------------------------------------
3-2                   3-72                 ANSI/AAMI EC53:1995/(R) 2008 ECG Cables and   Withdrawn and replaced
                                            Leadwires                                     with newer version
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
3-50                  ...................  AAMI/ANSI DF2-1996 (Revision of ANSI/AAMI     Withdrawn
                                            DF2-1989) Cardiac Defibrillator Devices
----------------------------------------------------------------------------------------------------------------
3-51                  ...................  AAMI /ANSI DF-39-1993 Automatic External      Withdrawn
                                            Defibrillators and Remote-Control
                                            Defibrillators
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[Page 24715]]


3-63                  ...................  ISO 11318:2002 Cardiac Defibrillators--       Contact person
                                            Connector Assembly DF-1 for Implantable
                                            Defibrillators--Dimensions and Test
                                            Requirements
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
3-70                  ...................  AAMI/ANSI SP10:2002/A1:2003--Amendment 1 to   Withdrawn
                                            ANSI/AAMI SP10:2002 Manual, Electronic, or
                                            Automated Sphygmomanometers
----------------------------------------------------------------------------------------------------------------
3-71                  ...................  AAMI/ANSI SP10:2002/A2:2006--Amendment 2 to   Withdrawn
                                            ANSI/AAMI SP10:2002 Manual, Electronic, or
                                            Automated Sphygmomanometers
----------------------------------------------------------------------------------------------------------------
C. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-78                  4-180                ISO 9168:2009 Dentistry--Hose Connectors for  Withdrawn and replaced
                                            Air Driven Dental Handpieces                  with newer version
----------------------------------------------------------------------------------------------------------------
4-87                  ...................  ADA/ANSI ADA Specification No. 69 - Dental    Reaffirmation
                                            Ceramic:1999
----------------------------------------------------------------------------------------------------------------
4-91                  ...................  ADA/ANSI ADA Specification No. 80 - Dental    Reaffirmation
                                            Material-Determination of Color
                                            Stability:2001
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
4-119                 ...................  ADA/ANSI Specification No. 82 - Dental        Reaffirmation
                                            Reversible/Irreversible Hydrocolloid
                                            Impression Material Systems: 1998/
                                            Reaffirmed 2003
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
4-160                 ...................  ANSI/ASA S3.1-1999 (R 2003) Maximum           Reaffirmation
                                            Permissible Ambient Noise Levels for
                                            Audiometric Test Rooms
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
4-164                 ...................  ANSI/ASA S3.7-1995 (R 2003) Method for        Reaffirmation
                                            Coupler Calibration of Earphones
----------------------------------------------------------------------------------------------------------------
4-166                 ...................  ANSI/ASA S3.20-1995 (R2003) Bioacoustical     Reaffirmation
                                            Terminology
----------------------------------------------------------------------------------------------------------------
4-167                 ...................  ANSI/ASA S3.21-2004 Methods for Manual Pure-  Reaffirmation
                                            Tone threshold Audiometry
----------------------------------------------------------------------------------------------------------------
4-168                 4-184                ANSI/ASA S3.25-2009 Occluded Ear Simulator    Withdrawn and replaced
                                                                                          with newer version
----------------------------------------------------------------------------------------------------------------
4-174                 4-185                ANSI/ASA S3.45-2009 Procedures for Testing    Withdrawn and replaced
                                            Basic Vestibular Function                     with newer version
----------------------------------------------------------------------------------------------------------------
4-176                 4-186                ANSI/ASA S12.2-2008 Criteria for Evaluating   Withdrawn and replaced
                                            Room Noise                                    with newer version
----------------------------------------------------------------------------------------------------------------
D. General
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
5-29                  ...................  AAMI/ANSI HE74-2001/ Human Factors Design     Reaffirmation
                                            Process for Medical Devices
----------------------------------------------------------------------------------------------------------------
E. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[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
----------------------------------------------------------------------------------------------------------------
7-97                  7-207                CLSI GP16-A3 Urinalysis                       Withdrawn and replaced
                                                                                          with newer version
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
F. Materials
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
G. Physical Medicine
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
16-20                 16-163               ISO 7176-5:2008 Wheelchairs--Part 5:          Withdrawn and replaced
                                            Determination of Dimensions, Mass and         with newer version
                                            Manoeuvring Space
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
H. Sterility
----------------------------------------------------------------------------------------------------------------
14-117                ...................  ANSI/AAMI ST35:2003 Handling and Biological   Withdrawn
                                            Decontamination of Reusable Medical Devices
                                            in Health Care Facilities and in
                                            Nonclinical Settings
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
14-255                14-281               ASTM F17-08 Standard Terminology Relating to  Withdrawn and replaced
                                            Flexible Barrier Packaging\1\                 with newer version
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
14-199                14-284               ASTM D4169-08 Standard Practice for           Withdrawn and replaced
                                            Performance Testing of Shipping Containers    with newer version
                                            and Systems\1\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[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
----------------------------------------------------------------------------------------------------------------
I. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
15-9                  15-17                ASTM F2311-08 Standard Guide for              Withdrawn and replaced
                                            Classification of Therapeutic Skin            with newer version
                                            Substitutes\1\
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------

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
------------------------------------------------------------------------
                                                         Reference No. &
Recognition No.            Title of Standard                  Date
------------------------------------------------------------------------
A. Cardiology
------------------------------------------------------------------------
3-77             Active Implantable Medical Devices--   ANSI/AAMI
                  Electromagnetic Compatibility--EMC     PC69:2007
                  Test Protocols for Implantable
                  Cardiac Pacemakers and Implantable
                  Cardioverter Defibrillators
------------------------------------------------------------------------
B. In Vitro Diagnostics
------------------------------------------------------------------------
7-209            Performance Metrics for Continuous     POCT 05-A
                  Interstitial Glucose Monitoring
------------------------------------------------------------------------
C. Orthopedics
------------------------------------------------------------------------
11-219           Standard Specification for             ASTM F 2026-08
                  Polyetheretherketone (PEEK) Polymers
                  for Surgical Implant Applications
------------------------------------------------------------------------
D. Physical Medicine
------------------------------------------------------------------------
16-166           Wheelchairs--Requirements and Test     ISO 7176-21:2009
                  Methods for Electromagnetic
                  Compatibility of Electrically
                  Powered Wheelchairs and Scooters,
                  and Battery Chargers
------------------------------------------------------------------------
E. Sterility
------------------------------------------------------------------------
14-286           Processing of Reusable Surgical        ANSI/AAMI
                  Textiles for Use in Health Care        ST65:2008
                  Facilities
------------------------------------------------------------------------

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

