
[Federal Register: March 18, 2009 (Volume 74, Number 51)]
[Notices]               
[Page 11586-11593]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr09-71]                         

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

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: 021

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: 021'' (Recognition List Number: 021), 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: 021'' to the Division of Small Manufacturers, International and 
Consumer Assistance, Center for Devices and Radiological Health (HFZ-
220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send two self-addressed adhesive labels to assist that office in 
processing your requests, or fax your request to 240-276-3151. 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: 021 
modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 7520 
Standish Place, Rockville, MD 20855, 240-276-8714.

[[Page 11587]]


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.

                   Table 1--Federal Register Citation
------------------------------------------------------------------------

------------------------------------------------------------------------
October 16, 1998 (63 FR 55617)       May 27, 2005 (70 FR 30756)
------------------------------------------------------------------------
July 12, 1999 (64 FR 37546)          November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
November 15, 2000 (65 FR 69022)      March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
May 7, 2001 (66 FR 23032)            June 23, 2006 (71 FR 36121)
------------------------------------------------------------------------
January 14, 2002 (67 FR 1774)        November 3, 2006 (71 FR 64718)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893)        May 21, 2007 (72 FR 28500)
------------------------------------------------------------------------
April 28, 2003 (68 FR 22391)         September 12, 2007 (72 FR 52142)
------------------------------------------------------------------------
March 8, 2004 (69 FR 10712)          December 19, 2007 (72 FR 71924)
------------------------------------------------------------------------
June 18, 2004 (69 FR 34176)          September 9, 2008 (73 FR 52358)
------------------------------------------------------------------------
October 4, 2004 (69 FR 59240)        ...................................
------------------------------------------------------------------------

    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: 021

    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: 021'' 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
----------------------------------------------------------------------------------------------------------------
                            Replacement
 Old Recognition No.      Recognition No.                      Standard                           Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-49                   .....................  ASTM F 1981-99 Standard Specification for   Withdrawn
                                               Suction Catheters for use in the
                                               Respiratory Tract
----------------------------------------------------------------------------------------------------------------
1-63                   1-77                   CGA V-1:2005 Standard for Compressed Gas    Withdrawn and replaced
                                               Cylinder Valve Outlet and Inlet             with newer version
                                               Connection
----------------------------------------------------------------------------------------------------------------
1-64                   1-78                   ASME PVHO-1-2007 Safety Standard for        Withdrawn and replaced
                                               Pressure Vessels for Human Occupancy        with newer version
----------------------------------------------------------------------------------------------------------------

[[Page 11588]]


1-71                   .....................  ISO 10651-5:2006 Lung Ventilators for       Withdrawn duplicate
                                               Medical Use--Particular requirements for
                                               Basic Safety and Essential Performance--
                                               Part 5: Gas-powered Emergency
                                               Resuscitators
----------------------------------------------------------------------------------------------------------------
1-74                   .....................  ISO 5360:2006 Anaesthetic Vaporizers--      Contact person
                                               Agent Specific Filling Systems
----------------------------------------------------------------------------------------------------------------
1-76                   1-79                   ISO 26825:2008 (E) Anaesthetic And          Withdrawn and replaced
                                               Respiratory Equipment--User-Applied         with newer version
                                               Labels For Syringes Containing Drugs Used
                                               During Anaesthesia--Colours, Design and
                                               Performance
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-71                   2-133                  ASTM F1408-97 (2008) Standard Practice for  Withdrawn and replaced
                                               Subcutaneous Screening Test for Implant     with newer version
                                               Materials
----------------------------------------------------------------------------------------------------------------
2-73                   2-134                  ASTM F2065-00(2006) Standard Practice for   Withdrawn and replaced
                                               Testing for Alternative Pathway             with newer version
                                               Complement Activation in Serum by Solid
                                               Materials
----------------------------------------------------------------------------------------------------------------
2-87                   .....................  AAMI/ANSI/ISO 10993-10:2002 Biological      Extent of Recognition,
                                               Evaluation of Medical Devices--Part 10:     Relevant Guidance,
                                               Tests for Irritation and Delayed-Type       and Contact Person
                                               Hypersensitivity
----------------------------------------------------------------------------------------------------------------
2-88                   2-135                  AAMI/ANSI/ISO 10993-12:2007 Biological      Withdrawn and replaced
                                               Evaluation of Medical Devices--Part 12:     with newer version
                                               Sample Preparation and Reference
                                               Materials
----------------------------------------------------------------------------------------------------------------
2-127                  .....................  ANSI/AAMI BE 78:2002/A1:2006 Biological     Withdrawn
                                               Evaluation of Medical Devices--Part 10:
                                               Tests For Irritation and Delayed-Type
                                               Hypersensitivity--Amendment 1
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular/Neurology
----------------------------------------------------------------------------------------------------------------
3-67                   .....................  ASTM F2129-06 Standard Test Method for      Offices, Devices
                                               Conducting Cyclic Potentiodynamic           Affected, Relevant
                                               Polarization Measurements to Determine      Guidance, CFR
                                               the Corrosion Susceptibility of Small       Citation and Product
                                               Implant Devices                             Codes, Contact Person
----------------------------------------------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-29                   .....................  IEC 60601-2-19 1996-10: Amendment 1--       Relevant guidance
                                               Medical Electrical Equipment Part 2:
                                               Particular Requirements for Safety of
                                               Baby Incubators
----------------------------------------------------------------------------------------------------------------
6-32                   .....................  IEC 60601-2-20 1996-10: Amendment 1--       Relevant guidance
                                               Medical Electrical Equipment Part 2:
                                               Particular Requirements for the Safety Of
                                               Transport Incubators
----------------------------------------------------------------------------------------------------------------
6-62                   .....................  ISO 8536-6:1995 Infusion Equipment for      Relevant guidance
                                               Medical Use--Part 6: Freeze Drying
                                               Closures for Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-63                   .....................  ISO 8536-7-1999: Infusion Equipment for     Relevant guidance
                                               Medical Use--Part 7: Caps Made of
                                               Aluminum-Plastics Combinations For
                                               Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-64                   .....................  ISO 8536-3-1999, Infusion Equipment for     Relevant guidance
                                               Medical Use--Part 3: Aluminum Caps for
                                               Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-119                  .....................  ANSI/AAMI BF7:1989/(R)2002/(R)2007 Blood    Reaffirmation 2007,
                                               Transfusion Micro-Filters                   Title, SDO, Date of
                                                                                           standard, Relevant
                                                                                           guidance
----------------------------------------------------------------------------------------------------------------
6-122                  .....................  ISO 8536-5-2004:, Infusion Equipment for    Relevant guidance
                                               Medical Use--Part 5: Burette Infusion
                                               Sets for Single Use, Gravity Feed
----------------------------------------------------------------------------------------------------------------
6-127                  .....................  ISO 1135-4-2004: Transfusion Equipment for  Relevant guidance
                                               Medical Use--Part 4: Transfusion Sets for
                                               Single Use
----------------------------------------------------------------------------------------------------------------
6-142                  .....................  ANSI/AAMI II36:2004 Medical Electrical      Title, Relevant
                                               Equipment--Part 2: Particular               guidance
                                               Requirements for Safety of Baby
                                               Incubators
----------------------------------------------------------------------------------------------------------------
6-143                  .....................  ANSI/AAMI II51:2004, Medical Electrical     Title, Relevant
                                               Equipment--Part 2: Particular               guidance
                                               Requirements for Safety of Transport
                                               Incubators
----------------------------------------------------------------------------------------------------------------

[[Page 11589]]


6-172                  .....................  ISO 8536-1:2006 Infusion Equipment for      Relevant guidance
                                               Medical Use--Part 1: Infusion Glass
                                               Bottles
----------------------------------------------------------------------------------------------------------------
6-173                  .....................  ISO 8536-2:2001 Corrigendum 1:2003,         Relevant guidance
                                               Infusion Equipment for Medical Use--Part
                                               2: Closures for Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-182                  .....................  IEC 60601-2-38 1996/Amendment 1:1999,       Relevant guidance
                                               Medical Electrical Equipment--Part 2-38:
                                               Particular Requirements for the Safety of
                                               Electrically Operated Hospital Beds
----------------------------------------------------------------------------------------------------------------
6-201                  .....................  ISO 8536-4:2007 Infusion Equipment for      Relevant guidance
                                               Medical Use--Part 4: Infusion Sets for
                                               Single Use, Gravity Feed
----------------------------------------------------------------------------------------------------------------
6-215                  .....................  ASTM F2132-01(2008)E1 Standard              Title
                                               Specification for Puncture Resistance of
                                               Materials Used in Containers for
                                               Discarded Medical Needles and Other
                                               Sharps
----------------------------------------------------------------------------------------------------------------
E. IVD
----------------------------------------------------------------------------------------------------------------
7-138                  7-169                  CLSI M27-A3 Reference Method for Broth      Withdrawn and replaced
                                               Dilution Antifungal Susceptibility          with newer version
                                               Testing of Yeasts
----------------------------------------------------------------------------------------------------------------
7-54                   .....................  CLSI D12-A2, Immunoprecipitin Analyses:     Title
                                               Procedures for Evaluating the Performance
                                               of Materials--Second Edition; Approved
                                               Guideline
----------------------------------------------------------------------------------------------------------------
7-71                   .....................  CLSI H15-A3, Reference and Selected         Contact person
                                               Procedures for the Quantitative
                                               Determination of Hemoglobin in Blood;
                                               Approved Standard--Third Edition
----------------------------------------------------------------------------------------------------------------
7-145                  .....................  CLSI H42-A2, Enumeration of                 Contact person
                                               Immunologically Defined Cell Populations
                                               by Flow Cytometry.
----------------------------------------------------------------------------------------------------------------
7-73                   7-170                  CLSI ILA21-A2 Clinical Evaluation of        Withdrawn and replaced
                                               Immunoassays                                with newer version
----------------------------------------------------------------------------------------------------------------
7-130                  .....................  CLSI H20-A2, Reference Leucocyte            Contact person
                                               Differential Count (Proportional) and
                                               Evaluation of Instrumental Methods;
                                               Approved Standard--Second Edition
----------------------------------------------------------------------------------------------------------------
7-164                  .....................  CLSI GP 28-A Microwave Device Use in the    Contact person
                                               Histology Laboratory; Approved Guideline
----------------------------------------------------------------------------------------------------------------
7-168                  7-171                  CLSI M38-A2 Reference Method for Broth      Withdrawn and replaced
                                               Dilution Antifungal Susceptibility          with newer version
                                               Testing of Filamentous Fungi
----------------------------------------------------------------------------------------------------------------
F. Neurology
----------------------------------------------------------------------------------------------------------------
3-3                    17-1                   AAMI NS28:1988/(R) 2006 Intracranial        Transferred, Date of
                                               Pressure Monitoring Devices                 standard, Extent of
                                                                                           recognition, Relevant
                                                                                           guidance
----------------------------------------------------------------------------------------------------------------
3-32                   17-2                   ASTM F1542-94(2000) Standard Specification  Transferred, Offices,
                                               for the Requirements and Disclosure of      Type of standard,
                                               Self-Closing Aneurysm Clips                 Extent of
                                                                                           recognition, Relevant
                                                                                           guidance, Contact
                                                                                           person
----------------------------------------------------------------------------------------------------------------
3-33                   17-3                   ISO 7197:2006 Neurosurgical implants--      Transferred--Withdrawn
                                               Sterile, Single-use hydrocephalus Shunts    and replaced with
                                               and Components                              newer version
----------------------------------------------------------------------------------------------------------------
3-39                   17-4                   ASTM F647-94(2006) Standard Practice for    Transferred--Withdrawn
                                               Evaluating and Specifying Implantable       and replaced with
                                               Shunt Assemblies for Neurosurgical          newer version
                                               Application
----------------------------------------------------------------------------------------------------------------
3-60                   17-5                   IEC 60601-2-10 1987/Amendment 1 2001        Transferred, Title
                                               Medical Electrical Equipment--Part 2-10:    change, Date of
                                               Particular Requirements for the Safety of   standard, Relevant
                                               Nerve and Muscle Stimulators                guidance, Contact
                                                                                           person
----------------------------------------------------------------------------------------------------------------
3-67                   17-6                   ASTM F2129-06 Standard Test Method for      Offices, Devices
                                               Conducting Cyclic Potentiodynamic           affected, Type of
                                               Polarization Measurements to Determine      Standard, Product
                                               the Corrosion Susceptibility of Small       code, Relevant
                                               Implant Devices                             guidance, Contact
                                                                                           person
----------------------------------------------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------

[[Page 11590]]


9-30                   9-55                   ANSI/ AAMI RD62:2006 Water Treatment        Withdrawn and replaced
                                               Equipment for Hemodialysis Applications     with newer version
----------------------------------------------------------------------------------------------------------------
9-32                   9-56                   ASTM D3492-08 Standard Specification for    Withdrawn and replaced
                                               Rubber Contraceptives (Male Condoms)        with newer version
----------------------------------------------------------------------------------------------------------------
9-34                   .....................  ISO 4074:2002/Cor.1:2003(E): Natural Latex  Extent of recognition,
                                               Rubber Condoms--Requirements and Test       Product codes,
                                               Methods, Technical Corrigendum 1            Relevant guidance
----------------------------------------------------------------------------------------------------------------
H. Radiology
----------------------------------------------------------------------------------------------------------------
12-48                  .....................  AIUM AOL, Acoustic Output Labeling          Relevant guidance
                                               Standard for Diagnostic Ultrasound
                                               Equipment: A Standard for How
                                               Manufacturers Should Specify Acoustic
                                               Output Data
----------------------------------------------------------------------------------------------------------------
12-55                  12-186                 IEC 60601-2-29 (2008) Medical Electrical    Withdrawn and replaced
                                               Equipment--Part 2-29: Particular            with newer version
                                               Requirements for the Basic Safety and
                                               Essential Performance of Radiotherapy
                                               Simulators--Third Edition
----------------------------------------------------------------------------------------------------------------
12-66                  .....................  AIUM MUS, Medical Ultrasound Safety         Relevant guidance
----------------------------------------------------------------------------------------------------------------
12-96                  12-187                 NEMA MS 3-2008 Determination of Image       Withdrawn and replaced
                                               Uniformity in Diagnostic Magnetic           with newer version
                                               Resonance Images
----------------------------------------------------------------------------------------------------------------
12-97                  12-188                 NEMA MS 1-2008 Determination of Signal-to-  Withdrawn and replaced
                                               Noise Ratio (SNR) in Diagnostic Magnetic    with newer version
                                               Resonance Imaging
----------------------------------------------------------------------------------------------------------------
12-100                 .....................  NEMA UD 3-2004, Standard for Real Time      Relevant guidance
                                               Display of Thermal and Mechanical
                                               Acoustic Output Indices on Diagnostic
                                               Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------
12-105                 .....................  NEMA UD 2-2004, Acoustic Output             Title, Relevant
                                               Measurement Standard for Diagnostic         guidance
                                               Ultrasound Equipment Version 3
----------------------------------------------------------------------------------------------------------------
12-139                 .....................  AIUM AOMS-2005, Acoustic Output             Relevant guidance
                                               Measurement Standard for Diagnostic
                                               Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------
12-140                 .....................  AIUM RTD1-2005, Standard for Real-Time      Relevant guidance
                                               Display of Thermal and Mechanical
                                               Acoustic Output Indices on Diagnostic
                                               Ultrasound Equipment Revision 1
----------------------------------------------------------------------------------------------------------------
12-161                 12-189                 IEC 60601-2-33 (2008) Medical Electrical    Withdrawn and replaced
                                               Equipment--Part 2-33: Particular            with a newer version
                                               Requirements for the Safety of Magnetic
                                               Resonance Equipment for Medical Diagnosis
                                               Consolidated Edition 2.2
----------------------------------------------------------------------------------------------------------------
12-182                 .....................  IEC 60601-2-37:2007, Medical Electrical     Relevant guidance
                                               Equipment--Part 2-37: Particular
                                               Requirements for the Basic Safety and
                                               Essential Performance of Ultrasonic
                                               Medical Diagnostic and Monitoring
                                               Equipment
----------------------------------------------------------------------------------------------------------------
12-184                 12-190                 IEC 61217 (2008) Radiotherapy Equipment--   Withdrawn and replaced
                                               Coordinates, Movements, and Scales          with newer version
                                               Consolidated Edition 1.2
----------------------------------------------------------------------------------------------------------------
I. Sterility
----------------------------------------------------------------------------------------------------------------
14-120                 14-257                 ASTM D3078--02(2008) Standard Test Method   Withdrawn and replaced
                                               for Determination of Leaks in Flexible      with newer version
                                               Packaging by Bubble Emission
----------------------------------------------------------------------------------------------------------------
14-148                 14-258                 ASTM F2250--03(2008) Standard Practice for  Withdrawn and replaced
                                               Evaluation of Chemical Resistance of        with newer version
                                               Printed Inks and Coatings on Flexible
                                               Packaging Materials
----------------------------------------------------------------------------------------------------------------
14-149                 14-259                 ASTM F2251--03(2008) Standard Test Method   Withdrawn and replaced
                                               for Thickness Measurement of Flexible       with newer version
                                               Packaging Material
----------------------------------------------------------------------------------------------------------------
14-150                 14-260                 ASTM F2252--03(2008) Standard Practice for  Withdrawn and replaced
                                               Evaluating Ink or Coating Adhesion to       with newer version
                                               Flexible Packaging Materials Using Tape
----------------------------------------------------------------------------------------------------------------
J. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-11                  15-13                  ASTM F2212-02(2008)e1, Standard Guide for   Withdrawn and replaced
                                               Characterization of Type I Collagen as a    with newer version
                                               Starting Material for Surgical Implants
                                               and Substrates for Tissue Engineered
                                               Medical Products
----------------------------------------------------------------------------------------------------------------


[[Page 11591]]

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: 021.

                                                     Table 3
----------------------------------------------------------------------------------------------------------------
    Recognition No.                           Title of Standard                          Reference No. & Date
----------------------------------------------------------------------------------------------------------------
A. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-160                   Maximum Permissible Ambient Noise Levels for Audiometric      ANSI ASA S3.1-1999 (R
                         Test Rooms                                                    2003)
----------------------------------------------------------------------------------------------------------------
4-161                   Method for Measuring the Intelligibility of Speech Over       ANSI ASA S3.2-1989 (R
                         Communication Systems                                         1999)
----------------------------------------------------------------------------------------------------------------
4-162                   Procedure for the Computation of Loudness of Steady Sounds    ANSI ASA S3.4-2007
----------------------------------------------------------------------------------------------------------------
4-163                   Methods for Calculation of the Speech Intelligibility Index   ANSI ASA S3.5-1997 (R
                                                                                       2007)
----------------------------------------------------------------------------------------------------------------
4-164                   Method for Coupler Calibration of Earphones                   ANSI ASA S3.7-1995 (R
                                                                                       2003)
----------------------------------------------------------------------------------------------------------------
4-165                   Mechanical Coupler for Measurement of Bone Vibrators          ANSI ASA S3.13-1987 (R
                                                                                       2007)
----------------------------------------------------------------------------------------------------------------
4-166                   Bioacoustical Terminology                                     ANSI ASA S3.20-1995 (R
                                                                                       2003)
----------------------------------------------------------------------------------------------------------------
4-167                   Methods for Manual Pure-Tone Threshold Audiometry             ANSI ASA S3.21-2004
----------------------------------------------------------------------------------------------------------------
4-168                   Occluded Ear Simulator                                        ANSI ASA S3.25-1989 (R
                                                                                       2003)
----------------------------------------------------------------------------------------------------------------
4-169                   Method of Measurement of Performance Characteristics of       ANSI ASA S3.35-2004
                         Hearing Aids under Simulated Real-Ear Working Conditions
----------------------------------------------------------------------------------------------------------------
4-170                   Specification for a Manikin for Simulated in situ Airborne    ANSI ASA S3.36-1985 (R
                         Acoustic Measurements                                         2006)
----------------------------------------------------------------------------------------------------------------
4-171                   Preferred Earhook Nozzle Thread for Postauricular Hearing     ANSI ASA S3.37-1987 (R
                         Aids                                                          2007)
----------------------------------------------------------------------------------------------------------------
4-172                   Testing Hearing Aids with a Broad-Band Noise Signal           ANSI ASA S3.42-1992 (R
                                                                                       2007)
----------------------------------------------------------------------------------------------------------------
4-173                   Determination of Occupational Noise Exposure and Estimation   ANSI ASA S3.44-1996 (R
                         of Noise-Induced Hearing Impairment                           2006)
----------------------------------------------------------------------------------------------------------------
4-174                   Procedures for Testing Basic Vestibular Function              ANSI ASA S3.45-1999
----------------------------------------------------------------------------------------------------------------
4-175                   Methods of Measurement of Real-Ear Performance                ANSI ASA S3.46-1997 (R
                         Characteristics of Hearing Aids                               2002)
----------------------------------------------------------------------------------------------------------------
4-176                   Criteria for Evaluating Room Noise                            ANSI ASA S12.2-1995 (R
                                                                                       1999)
----------------------------------------------------------------------------------------------------------------
4-177                   Rating Noise with Respect to Speech Interference              ANSI ASA S12.65-2006
----------------------------------------------------------------------------------------------------------------
B. General
----------------------------------------------------------------------------------------------------------------
5-45                    Standard Practice for Performance Testing of Packages for     ASTM D7386-08
                         Single Delivery Systems
----------------------------------------------------------------------------------------------------------------
C. IVD
----------------------------------------------------------------------------------------------------------------
7-172                   Defining, Establishing, and Verifying Reference Intervals in  C28-P3
                         the Clinical Laboratory
----------------------------------------------------------------------------------------------------------------
7-173                   Harmonization of Glycohemoglobin Measurements                 C44-A
----------------------------------------------------------------------------------------------------------------
7-174                   Estimation of Total Analytical Error for Clinical Laboratory  EP21-A
----------------------------------------------------------------------------------------------------------------
7-175                   Apolipoprotein Immunoassays: Development and Recommended      ILA15-A
                         Performance Characteristics
----------------------------------------------------------------------------------------------------------------
7-176                   Immunoassay Interference by Endogenous Antibodies             ILA30-A
----------------------------------------------------------------------------------------------------------------

[[Page 11592]]


7-177                   Performance Standards for Antimicrobial Susceptibility        M100-S18
                         Testing
----------------------------------------------------------------------------------------------------------------
7-178                   Quality Control for Commercially Prepared Microbiological     M22-A3
                         Culture Media
----------------------------------------------------------------------------------------------------------------
7-179                   Reference Method for Broth Dilution Antifungal                M27-S3
                         Susceptibility Testing of Yeasts
----------------------------------------------------------------------------------------------------------------
7-180                   Western Blot Assay for Antibodies to Borrelia burgdorferi     M34-A
----------------------------------------------------------------------------------------------------------------
7-181                   Abbreviated Identification of Bacteria and Yeasts             M35-A
----------------------------------------------------------------------------------------------------------------
7-182                   Clinical Use and Interpretation of Serologic Tests for        M36-A
                         Toxoplasma gondii
----------------------------------------------------------------------------------------------------------------
7-183                   Reference Method for Broth Dilution Antifungal                M38-A2
                         Susceptibility Testing of Filamentous Fungi
----------------------------------------------------------------------------------------------------------------
7-184                   Quality Control of Microbiological Transport Systems          M40-A
----------------------------------------------------------------------------------------------------------------
7-185                   Viral Culture                                                 M41-A
----------------------------------------------------------------------------------------------------------------
7-186                   Methods for Antifungal Disk Diffusion Susceptibility Testing  M44-A
----------------------------------------------------------------------------------------------------------------
7-187                   Zone Diameter Interpretive Standards, Corresponding Minimal   M44-S2
                         Inhibitory Concentration (MIC) Interpretive Breakpoints,
                         and Quality Control Limits for Antifungal Disk Diffusion
                         Susceptibility Testing of Yeast
----------------------------------------------------------------------------------------------------------------
7-188                   Methods for Antimicrobial Dilution and Disk Susceptibility    M45-A
                         Testing of Infrequently Isolated or Fastidious Bacteria
----------------------------------------------------------------------------------------------------------------
7-189                   Principles and Procedures for Blood Cultures                  M47-A
----------------------------------------------------------------------------------------------------------------
7-190                   Quality Control for Commercial Microbial Identification       M50-A
                         Systems
----------------------------------------------------------------------------------------------------------------
7-191                   Collection, Transport, Preparation, and Storage of Specimens  MM13-A
----------------------------------------------------------------------------------------------------------------
7-192                   Interpretive Criteria for Identification of Bacteria and      MM18-A
                         Fungi by DNA Target Sequencing
----------------------------------------------------------------------------------------------------------------
7-193                   Evaluation of the Linearity of Quantitative Measurement       EP06-A
----------------------------------------------------------------------------------------------------------------
7-194                   Protocols for Determination of Limits of Detection and        EP17-A
                         Limits of Quantitation
----------------------------------------------------------------------------------------------------------------
D. Neurology
----------------------------------------------------------------------------------------------------------------
17-7                    Neurosurgical implants--Sterile, Single-use Hydrocephalus     ISO 7197:2006/Technical
                         Shunts and Components                                         Corrigendum1:2007
----------------------------------------------------------------------------------------------------------------
E. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-57                    Natural Latex Rubber Condoms--Requirements and Test Methods,  ISO 4074:2002/
                         Technical Corrigendum 2                                       Cor.2:2008(E)
----------------------------------------------------------------------------------------------------------------
F. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-58                   Laser Systems for Corneal Reshaping                           ANSI Z80.11-2007
----------------------------------------------------------------------------------------------------------------
G. Radiology
----------------------------------------------------------------------------------------------------------------
12-191                  Ultrasonics--Field Characterization--Test Methods for the     IEC 62359:2005
                         Determination of Thermal and Mechanical Indices Related to
                         Medical Diagnostic Ultrasonic Fields
----------------------------------------------------------------------------------------------------------------
H. Software/Informatic
----------------------------------------------------------------------------------------------------------------
13-25                   Managing and Validating Laboratory Information Systems;       CLSI AUTO8-A
                         Approved Guideline
----------------------------------------------------------------------------------------------------------------
13-26                   Autoverification of Clinical Laboratory Test Results;         CLSI AUTO10-A
                         Approved Guideline
----------------------------------------------------------------------------------------------------------------
13-27                   IT Security of In Vitro Diagnostic Instruments and Software   CLSI AUTO11-A
                         Systems; Approved Standard
----------------------------------------------------------------------------------------------------------------
13-28                   Remote Access to Clinical Laboratory Diagnostic Devices via   CLSI AUTO9-A
                         the Internet; Approved Standard
----------------------------------------------------------------------------------------------------------------
I. Sterility
----------------------------------------------------------------------------------------------------------------
14-261                  Sterilization of Health Care Products--Moist Heat--Part 1:    ANSI/AAMI/ISO 17665-1:2006
                         Requirements for the Development, Validation, and Routine
                         Control of a Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------


[[Page 11593]]

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 document 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 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. 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 includes 
the guidance as well as the current list of recognized standards and 
other standards related documents. After publication in the Federal 
Register, this document announcing ``Modification to the List of 
Recognized Standards, Recognition List Number: 021'' 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: 021. These modifications 
to the list or recognized standards are effective upon publication of 
this document in the Federal Register.

    Dated: March 10, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-5858 Filed 3-17-09; 8:45 am]

BILLING CODE 4160-01-S
