
[Federal Register: September 8, 2009 (Volume 74, Number 172)]
[Notices]               
[Page 46203-46214]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se09-79]                         

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

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: 022

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 46204]]

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: 022'' (Recognition List Number: 022), 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: 022'' 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, 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: 022 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 of the act 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.--Federal Register Citation
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)        ...................................
------------------------------------------------------------------------

    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: 022

    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: 022'' 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
----------------------------------------------------------------------------------------------------------------
1-37                   1-80                   CGA C-9:2004 (Reaffirmed 2008) Standard     Withdrawn and replaced
                                               Color Marking of Compressed Gas             with newer version
                                               Containers for Medical Use
----------------------------------------------------------------------------------------------------------------

[[Page 46205]]


1-68                   1-81                   CGA V-5:2008 Diameter-Index Safety System   Withdrawn and replaced
                                               Noninterchangeable Low Pressure             with newer version
                                               Connections for Medical Gas Applications
----------------------------------------------------------------------------------------------------------------
1-51                   .....................  ASTM F1100-90 (1997) Standard               Withdrawn
                                               Specification for Ventilators Intended
                                               for Use in Critical Care
----------------------------------------------------------------------------------------------------------------
1-59                   .....................  ASTM F1456-01 Standard Specification for    Withdrawn
                                               Minimum Performance and Safety
                                               Requirements for Capnometers
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-64                   .....................  ANSI/AAMI/ISO 10993-5:1999 Biological       Contact person, Extent
                                               Evaluation of Medical Devices--Part 5:      of recognition and
                                               Tests for In Vitro Cytotoxicity             Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-82                   .....................  ASTM F2147-01 Standard Practice for Guinea  Contact person and
                                               Pig: Split Adjuvant and Closed Patch        Extent of recognition
                                               Testing for Contact Allergens
----------------------------------------------------------------------------------------------------------------
2-83                   2-136                  ASTM E1262-88 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Guide for Performance of Chinese Hamster    with newer version
                                               Ovary Cell/Hypoxanthine Guanine
                                               Phosphoribosyl Transferase Gene Mutation
                                               Assay
----------------------------------------------------------------------------------------------------------------
2-84                   2-137                  ASTM E1263-97 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Guide for Conduct of Micronucleus Assays    with newer version
                                               in Mammalian Bone Marrow Erythrocytes
----------------------------------------------------------------------------------------------------------------
2-85                   2-138                  ASTM E1280-97 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Guide for Performing the Mouse Lymphoma     with newer version
                                               Assay for Mammalian Cell Mutagenicity
----------------------------------------------------------------------------------------------------------------
2-87                   .....................  ISO 10993-10:2002 Biological Evaluation of  Extent of recognition
                                               Medical Devices--Part 10: Tests for         and Relevant guidance
                                               Irritation and Delayed-type
                                               Hypersensitivity
----------------------------------------------------------------------------------------------------------------
2-90                   2-139                  ASTM E1397-91 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Practice for In Vitro Rat Hepatocyte DNA    with newer version
                                               Repair Assay
----------------------------------------------------------------------------------------------------------------
2-91                   2-140                  ASTM E1398-91 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Practice for In Vivo Rat Hepatocyte DNA     with newer version
                                               Repair Assay
----------------------------------------------------------------------------------------------------------------
2-93                   .....................  ASTM F763-04 Standard Practice for Short-   Extent of recognition
                                               Term Screening of Implant Materials         and Contact person
----------------------------------------------------------------------------------------------------------------
2-94                   .....................  ASTM F981-04 Standard Practice for          Extent of recognition
                                               Assessment of Compatibility of              and Contact person
                                               Biomaterials for Surgical Implants with
                                               Respect to Effect of Materials on Muscle
                                               and Bone
----------------------------------------------------------------------------------------------------------------
2-95                   2-141                  ASTM F1984-99 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Practice for Testing for Whole Complement   with newer version
                                               Activation in Serum by Solid Materials
----------------------------------------------------------------------------------------------------------------
2-97                   2-142                  ASTM F1983-99 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Practice for Assessment of Compatibility    with newer version
                                               of Absorbable/Resorbable Biomaterials for
                                               Implant Applications
----------------------------------------------------------------------------------------------------------------
2-98                   .....................  ANSI/AAMI/ISO 10993-1:2003 Biological       Title, Extent of
                                               Evaluation of Medical Devices--Part 1:      recognition, Relevant
                                               Evaluation and Testing                      guidance and Contact
                                                                                           person
----------------------------------------------------------------------------------------------------------------
2-99                   2-143                  ASTM F1904-98 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Practice for Testing the Biological         with newer version
                                               Responses to Particles in vivo
----------------------------------------------------------------------------------------------------------------
2-100                  .....................  ASTM E1372-95 (Reapproved 2003) Standard    Contact person
                                               Test Method for Conducting a 90-Day Oral
                                               Toxicity Study in Rats
----------------------------------------------------------------------------------------------------------------
2-106                  2-144                  ASTM F619-03 (Reapproved 2008) Standard     Withdrawn and replaced
                                               Practice for Extraction of Medical          with newer version
                                               Plastics
----------------------------------------------------------------------------------------------------------------
2-108                  .....................  ASTM F1905-98(2003) Standard Practice for   Contact person and
                                               Selecting Tests for Determining the         Extent of recognition
                                               Propensity of Materials to Cause
                                               Immunotoxicity
----------------------------------------------------------------------------------------------------------------
2-114                  .....................  ASTM F1877-05 Standard Practice for         Extent of recognition
                                               Characterization of Particles               and Contact person
----------------------------------------------------------------------------------------------------------------

[[Page 46206]]


2-115                  .....................  ASTM F895-84 (Reapproved 2006) Standard     Extent of recognition,
                                               Test Method for Agar Diffusion Cell         Relevant guidance and
                                               Culture Screening for Cytotoxicity          Contact person
----------------------------------------------------------------------------------------------------------------
2-116                  2-145                  ASTM F1439-03 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Guide for Performance of Lifetime           with newer version
                                               Bioassay for the Tumorigenic Potential of
                                               Implant Materials
----------------------------------------------------------------------------------------------------------------
2-118                  .....................  ANSI/AAMI/ISO 10993-11:2006 Biological      Extent of recognition,
                                               Evaluation of Medical Devices--Part 11:     Relevant guidance and
                                               Tests for Systemic Toxicity                 Contact person
----------------------------------------------------------------------------------------------------------------
2-119                  .....................  ASTM F813-07 Standard Practice for Direct   Contact person
                                               Contact Cell Culture Evaluation of
                                               Materials for Medical Devices
----------------------------------------------------------------------------------------------------------------
2-121                  2-146                  ASTM F2148-071 Standard Practice for        Withdrawn and replaced
                                               Evaluation of Delayed Contact               with newer version
                                               Hypersensitivity Using the Murine Local
                                               Lymph Node Assay (LLNA)
----------------------------------------------------------------------------------------------------------------
2-122                  .....................  ASTM F719-81 (Reapproved 2007)1 Standard    Contact person and
                                               Practice for Testing Biomaterials in        Relevant guidance
                                               Rabbits for Primary Skin Irritation
----------------------------------------------------------------------------------------------------------------
2-124                  .....................  ASTM F750-87 (Reapproved 2007)1 Standard    Extent of recognition,
                                               Practice for Evaluating Material Extracts   Relevant guidance and
                                               by Systemic Injection in the Mouse          Contact person
----------------------------------------------------------------------------------------------------------------
2-125                  .....................  ASTM F749-98 (Reapproved 2007)1 Standard    Extent of recognition,
                                               Practice for Evaluating Material Extracts   Relevant guidance and
                                               by Intracutaneous Injection in the Rabbit   Contact person
----------------------------------------------------------------------------------------------------------------
2-126                  .....................  ASTM F748-06 Standard Practice for          Extent of recognition,
                                               Selecting Generic Biological Test Methods   Relevant guidance and
                                               for Materials and Devices                   Contact person
----------------------------------------------------------------------------------------------------------------
2-128                  2-147                  USP 32-NF26 Biological Tests <87> 2009      Withdrawn and replaced
                                               Biological Reactivity Test, In Vitro--      with newer version
                                               Direct Contact Test
----------------------------------------------------------------------------------------------------------------
2-129                  2-148                  USP 32-NF26 Biological Tests <88>           Withdrawn and replaced
                                               Biological Reactivity Test, In Vitro--      with newer version
                                               Elution Test
----------------------------------------------------------------------------------------------------------------
2-130                  2-149                  USP 32-NF26 Biological Tests <88>           Withdrawn and replaced
                                               Biological Reactivity Tests, In Vivo        with newer version
                                               Procedure--Preparation of Sample
----------------------------------------------------------------------------------------------------------------
2-131                  2-150                  USP 32-NF26 Biological Tests <88>           Withdrawn and replaced
                                               Biological Reactivity Test, In Vivo,        with newer version
                                               Classification of Plastics--
                                               Intracutaneous Test
----------------------------------------------------------------------------------------------------------------
2-132                  2-151                  USP 32-NF26 Biological Tests <88>           Withdrawn and replaced
                                               Biological Reactivity Tests, In Vivo,       with newer version
                                               Classification of Plastics--Systemic
                                               Injection Test
----------------------------------------------------------------------------------------------------------------
2-133                  .....................  ASTM F1408-97 (Reapproved 2008) Standard    Contact person
                                               Practice for Subcutaneous Screening Test
                                               for Implant Materials
----------------------------------------------------------------------------------------------------------------
2-134                  .....................  ASTM F2065-00 (2006) Standard Practice for  Contact person
                                               Testing for Alternative Pathway
                                               Complement Activation in Serum by Solid
                                               Materials
----------------------------------------------------------------------------------------------------------------
2-135                  .....................  AAMI/ANSI/ISO 10993-12:2007 Biological      Extent of recognition,
                                               Evaluation of Medical Devices--Part 12:     Relevant guidance and
                                               Sample Preparation and Reference            Contact person
                                               Materials
----------------------------------------------------------------------------------------------------------------
C. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-69                   4-178                  ISO 6872:2008 Dentistry--Ceramic Materials  Withdrawn and replaced
                                                                                           with newer version
----------------------------------------------------------------------------------------------------------------
4-73                   4-179                  ISO 7405: 2008 Dentistry--Evaluation of     Withdrawn and replaced
                                               Biocompatibility of Medical Devices Used    with newer version
                                               in Dentistry
----------------------------------------------------------------------------------------------------------------
4-175                  .....................  ANSI ASA S3.46-1997 (R 2007) Methods of     Reaffirmation
                                               Measurement of Real-Ear Performance
                                               Characteristics of Hearing Aids
----------------------------------------------------------------------------------------------------------------
D. General
----------------------------------------------------------------------------------------------------------------

[[Page 46207]]


5-12                   5-47                   ISO 10012:2003 Measurement Management       Withdrawn and replaced
                                               Systems--Requirements for Measurement       with newer version
                                               Processes and Measuring Equipment
----------------------------------------------------------------------------------------------------------------
5-15                   5-48                   ANSI/ASQ Z1.9-2008 Sampling Procedures and  Withdrawn and replaced
                                               Tables for Inspection by Variables for      with newer version
                                               Percent Nonconforming
----------------------------------------------------------------------------------------------------------------
5-27                   .....................  IEC 60601-1-1 Ed. 2.0 2000 Medical          Title
                                               Electrical Equipment--Part 1-1: General
                                               Requirements for Safety--Collateral
                                               Standard: Safety requirements for Medical
                                               Electrical Systems
----------------------------------------------------------------------------------------------------------------
5-36                   .....................  ISO/TR 16142:2006 Medical Devices--         Title
                                               Guidance on the Selection of Standards in
                                               Support of Recognized Essential
                                               Principles of Safety and Performance of
                                               Medical Devices
----------------------------------------------------------------------------------------------------------------
5-41                   .....................  IEC 60601-1-4 (2000) Consol. Ed. 1.1        Title
                                               Medical Electrical Equipment--Part 1-4:
                                               General Requirements for Safety--
                                               Collateral Standard: Programmable
                                               Electrical Medical Systems
----------------------------------------------------------------------------------------------------------------
5-44                   5-49                   IEC 60601-1-8, Ed. 1 Medical Electrical     Withdrawn and re-
                                               Equipment--Part 1-8: General Requirements   recognized previous
                                               for Safety--Collateral Standard: Alarm      version
                                               Systems--Requirements, Tests and
                                               Guidelines--General Requirements and
                                               Guidelines for Alarm Systems in Medical
                                               Equipment
----------------------------------------------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-63                   6-216                  ISO 8536-7:2009 Infusion Equipment for      Withdrawn and replaced
                                               Medical Use--Part 7: Caps Made of           with newer version
                                               Aluminum-plastics Combinations for
                                               Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-112                  .....................  ANSI/AAMI PB70:2003 Liquid Barrier          Contact person
                                               Performance and Classification of
                                               Protective Apparel and Drapes Intended
                                               for Use in Health Care Facilities
----------------------------------------------------------------------------------------------------------------
6-118                  .....................  ASTM F2196-02 Standard Specification for    CFR citation and
                                               Circulating Liquid and Forced Air Patient   product code
                                               Temperature Management Devices
----------------------------------------------------------------------------------------------------------------
6-144                  .....................  ASTM D5712--051 Standard Test Method for    Title and Contact
                                               Analysis of Aqueous Extractable Protein     person
                                               in Natural Rubber and Its Products Using
                                               the Modified Lowry Method
----------------------------------------------------------------------------------------------------------------
6-145                  .....................  ASTM D3578-051 Standard Specification for   Title and Contact
                                               Rubber Examination Gloves                   person
----------------------------------------------------------------------------------------------------------------
6-147                  .....................  ASTM D6978-05 Standard Practice for         Contact person and
                                               Assessment of Resistance of Medical         Relevant guidance
                                               Gloves to Permeation by Chemotherapy
                                               Drugs
----------------------------------------------------------------------------------------------------------------
6-149                  .....................  ASTM D7160-05 Standard Practice for         Contact person
                                               Determination of Expiration Dating for
                                               Medical Gloves
----------------------------------------------------------------------------------------------------------------
6-150                  .....................  ASTM D7161-05 Standard Practice for         Contact person
                                               Determination of Real Time Expiration
                                               Dating of Mature Medical Gloves Stored
                                               Under Typical Warehouse Conditions
----------------------------------------------------------------------------------------------------------------
6-165                  .....................  ASTM D6977-041 Standard Specification for   Title and Contact
                                               Polychloroprene Examination Gloves for      person
                                               Medical Application
----------------------------------------------------------------------------------------------------------------
6-167                  .....................  ASTM D6319-00a (Reapproved 2005)1 Standard  Title and Contact
                                               Specification for Nitrile Examination       person
                                               Gloves for Medical Application
----------------------------------------------------------------------------------------------------------------
6-168                  .....................  ASTM D3577-091 Standard Specification for   Withdrawn and replaced
                                               Rubber Surgical Gloves                      with newer version
----------------------------------------------------------------------------------------------------------------
6-175                  .....................  ASTM D5151-06 Standard Test Method for      Contact person
                                               Detection of Holes in Medical Gloves
----------------------------------------------------------------------------------------------------------------
6-178                  .....................  ASTM D6124-06 Standard Test Method for      Contact person
                                               Residual Powder on Medical Gloves
----------------------------------------------------------------------------------------------------------------
6-183                  .....................  ASTM D5250-061 Standard Specification for   Title and Contact
                                               Poly(vinyl chloride) Gloves for Medical     person
                                               Application
----------------------------------------------------------------------------------------------------------------
6-186                  6-217                  ASTM F1670-08 Standard Test Method for      Withdrawn and replaced
                                               Resistance of Materials Used in             with newer version
                                               Protective Clothing to Penetration by
                                               Synthetic Blood
----------------------------------------------------------------------------------------------------------------

[[Page 46208]]


6-205                  6-218                  USP 32:2009 Nonabsorbable Surgical Suture   Withdrawn and replaced
                                                                                           with newer version
----------------------------------------------------------------------------------------------------------------
6-206                  6-219                  USP 32<11>:2009 Sterile Sodium Chloride     Withdrawn and replaced
                                               for Irrigation                              with newer version
----------------------------------------------------------------------------------------------------------------
6-207                  6-220                  USP 32:2009 Absorbable Surgical Suture      Withdrawn and replaced
                                                                                           with newer version
----------------------------------------------------------------------------------------------------------------
6-208                  6-221                  USP 32<881>:2009 Tensile Strength           Withdrawn and replaced
                                                                                           with newer version
----------------------------------------------------------------------------------------------------------------
6-209                  6-222                  USP 32<861>:2009 Sutures--Diameter          Withdrawn and replaced
                                                                                           with newer version
----------------------------------------------------------------------------------------------------------------
6-210                  6-223                  USP 32<871>:2009 Sutures Needle Attachment  Withdrawn and replaced
                                                                                           with newer version
----------------------------------------------------------------------------------------------------------------
6-211                  6-224                  USP 32<11>:2009 Sterile Water for           Withdrawn and replaced
                                               Irrigation                                  with newer version
----------------------------------------------------------------------------------------------------------------
6-212                  6-225                  USP 32<11>:2009 Heparin Lock Flush          Withdrawn and replaced
                                               Solution                                    with newer version
----------------------------------------------------------------------------------------------------------------
6-213                  6-226                  USP 32<11>:2009 Sodium Chloride Injection   Withdrawn and replaced
                                                                                           with newer version
----------------------------------------------------------------------------------------------------------------
F. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-156                  7-195                  CLSI M02-A10, Performance Standards for     Withdrawn and replaced
                                               Antimicrobial Disk Susceptibility Tests     with newer version
----------------------------------------------------------------------------------------------------------------
7-158                  7-196                  CLSI M07-A8, Methods for Dilution           Withdrawn and replaced
                                               Antimicrobial Susceptibility Tests for      with newer version
                                               Bacteria that Grow Aerobically
----------------------------------------------------------------------------------------------------------------
7-160                  7-197                  CLSI M35-A2, Abbreviated Identification of  Withdrawn and replaced
                                               Bacteria and Yeast                          with newer version
----------------------------------------------------------------------------------------------------------------
7-78                   7-198                  CLSI M23-A3, Development of In Vitro        Withdrawn and replaced
                                               Susceptibility Testing Criteria and         with newer version
                                               Quality Control Parameters
----------------------------------------------------------------------------------------------------------------
7-177                  7-199                  CLSI M100-S19 Performance Standards for     Withdrawn and replaced
                                               Antimicrobial Susceptibility Testing        with newer version
----------------------------------------------------------------------------------------------------------------
7-161                  7-200                  CLSI M48-A, Laboratory Detection and        Withdrawn and replaced
                                               Identification of Mycobacteria              with newer version
----------------------------------------------------------------------------------------------------------------
7-102                  .....................  NCCLS H1-A5, Tubes and Additives for        Contact Person
                                               Venous Blood Specimen Collection
----------------------------------------------------------------------------------------------------------------
7-101                  .....................  NCCLS H51-A, Assays of vonWillebrand        Contact Person
                                               Factor Antigen and Ristocetin Cofactor
                                               Activity
----------------------------------------------------------------------------------------------------------------
7-165                  .....................  CLSI H20-A2, Reference Leukocyte (WBC)      Contact Person
                                               Differential Count (Proportional) and
                                               Evaluation of Instrumental Methods
----------------------------------------------------------------------------------------------------------------
7-103                  7-201                  CLSI H3-A6, Procedures for the Collection   Withdrawn and replaced
                                               of Diagnostic Blood Specimens by            with newer version
                                               Venipuncture
----------------------------------------------------------------------------------------------------------------
7-81                   7-202                  CLSI C28-A3 Defining, Establishing, and     Withdrawn and replaced
                                               Verifying Reference Intervals in the        with newer version
                                               Clinical Laboratory
----------------------------------------------------------------------------------------------------------------
7-144                  7-203                  CLSI H04-A6, Procedures and Devices for     Withdrawn and replaced
                                               the Collection of Diagnostic Capillary      with newer version
                                               Blood Specimens
----------------------------------------------------------------------------------------------------------------
G. Materials
----------------------------------------------------------------------------------------------------------------
8-32                   8-163                  ASTM F1586-08 Standard Specification for    Withdrawn and replaced
                                               Wrought Nitrogen Strengthened 21 Chromium-  with newer version
                                               10Nickel-3Manganese-2.5Molybdenum
                                               Stainless Steel Bar for Surgical Implants
                                               (UNS S31675)
----------------------------------------------------------------------------------------------------------------

[[Page 46209]]


8-44                   8-164                  ASTM F136-081 Standard Specification for    Withdrawn and replaced
                                               Wrought Titanium-6 Aluminum-4 Vanadium      with newer version
                                               ELI (Extra Low Interstitial) Alloy for
                                               Surgical Implant Applications (UNS
                                               R56401)
----------------------------------------------------------------------------------------------------------------
8-49                   8-165                  ASTM F1058-08 Standard Specification for    Withdrawn and replaced
                                               Wrought 40Cobalt-20Chromium-16Iron-         with newer version
                                               15Nickel-7Molybdenum Alloy Wire and Strip
                                               for Surgical Implant Applications (UNS
                                               R30003 and UNS R30008)
----------------------------------------------------------------------------------------------------------------
8-50                   8-166                  ASTM F1091-08 Standard Specification for    Withdrawn and replaced
                                               Wrought Cobalt-20 Chromium-15 Tungsten-10   with newer version
                                               Nickel Alloy Surgical Fixation Wire (UNS
                                               R30605)
----------------------------------------------------------------------------------------------------------------
8-52                   8-167                  ASTM F1350-08 Standard Specification for    Withdrawn and replaced
                                               Wrought 18 Chromium-14 Nickel-2.5           with newer version
                                               Molybdenum Stainless Steel Surgical
                                               Fixation Wire (UNS S31673)
----------------------------------------------------------------------------------------------------------------
8-53                   8-168                  ASTM F1472-081 Standard Specification for   Withdrawn and replaced
                                               Wrought Titanium -6Aluminum -4Vanadium      with newer version
                                               Alloy for Surgical Implant Applications
                                               (UNS R56400)
----------------------------------------------------------------------------------------------------------------
8-76                   8-169                  ASTM F138-08 Standard Specification for     Withdrawn and replaced
                                               Wrought 18 Chromium-14 Nickel-2.5           with newer version
                                               Molybdenum Stainless Steel Bar and Wire
                                               for Surgical Implants (UNS S31673)
----------------------------------------------------------------------------------------------------------------
8-79                   8-170                  ASTM F961-08 Standard Specification for     Withdrawn and replaced
                                               35Cobalt-35 Nickel-20 Chromium-10           with newer version
                                               Molybdenum Alloy Forgings for Surgical
                                               Implants (UNS R30035)
----------------------------------------------------------------------------------------------------------------
8-81                   8-171                  ASTM F1609-08 Standard Specification for    Withdrawn and replaced
                                               Calcium Phosphate Coatings for              with newer version
                                               Implantable Materials
----------------------------------------------------------------------------------------------------------------
8-86                   8-172                  ASTM F1926/F1926M-08 Standard Test Method   Withdrawn and replaced
                                               for Evaluation of the Environmental         with newer version
                                               Stability of Calcium Phosphate Granules,
                                               Fabricated Forms, and Coatings
----------------------------------------------------------------------------------------------------------------
8-94                   8-173                  ASTM F601-03 (Reapproved 2008) Standard     Withdrawn and replaced
                                               Practice for Fluorescent Penetrant          with newer version
                                               Inspection of Metallic Surgical Implants
----------------------------------------------------------------------------------------------------------------
8-95                   8-174                  ASTM F629-02 (Reapproved 2007)1 Standard    Withdrawn and replaced
                                               Practice for Radiography of Cast Metallic   with newer version
                                               Surgical Implants
----------------------------------------------------------------------------------------------------------------
8-110                  8-175                  ASTM F1377-08 Standard Specification for    Withdrawn and replaced
                                               Cobalt-28 Chromium-6 Molybdenum Powder      with newer version
                                               for Coating of Orthopedic Implants (UNS
                                               R30075)
----------------------------------------------------------------------------------------------------------------
8-118                  8-176                  ASTM F2503-08 Standard Practice for         Withdrawn and replaced
                                               Marking Medical Devices and Other Items     with newer version
                                               for Safety in the Magnetic Resonance
                                               Environment
----------------------------------------------------------------------------------------------------------------
8-133                  8-177                  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
----------------------------------------------------------------------------------------------------------------
8-143                  8-178                  ASTM F648-071 Standard Specification for    Withdrawn and replaced
                                               Ultra-High-Molecular-Weight Polyethylene    with newer version
                                               Powder and Fabricated Form for Surgical
                                               Implants
----------------------------------------------------------------------------------------------------------------
8-144                  8-179                  ASTM F754-08 Standard Specification for     Withdrawn and replaced
                                               Implantable Polytetrafluoroethylene         with newer version
                                               (PTFE) Sheet, Tube, and Rod Shapes
                                               Fabricated from Granular Molding Powders
----------------------------------------------------------------------------------------------------------------
8-146                  8-180                  ASTM F2066-08 Standard Specification for    Withdrawn and replaced
                                               Wrought Titanium-15 Molybdenum Alloy for    with newer version
                                               Surgical Implant Applications (UNS
                                               R58150)
----------------------------------------------------------------------------------------------------------------
8-148                  8-181                  ASTM F899-09 Standard Specification for     Withdrawn and replaced
                                               Wrought Stainless Steels for Surgical       with newer version
                                               Instruments
----------------------------------------------------------------------------------------------------------------
8-152                  8-182                  ASTM F1537-08 Standard Specification for    Withdrawn and replaced
                                               Wrought Cobalt-28-Chromium-6-Molybdenum     with newer version
                                               Alloys for Surgical Implants (UNS R31537,
                                               UNS R31538, and UNS R31539)
----------------------------------------------------------------------------------------------------------------
8-160                  8-183                  ASTM F560-08 Standard Specification for     Withdrawn and replaced
                                               Unalloyed Tantalum for Surgical Implant     with newer version
                                               Applications (UNS R05200, UNS R05400)
----------------------------------------------------------------------------------------------------------------

[[Page 46210]]


8-161                  8-184                  ASTM F2516-072 Standard Test Method for     Withdrawn and replaced
                                               Tension Testing of Nickel-Titanium          with newer version
                                               Superelastic Materials
----------------------------------------------------------------------------------------------------------------
8-162                  8-185                  ASTM F451-08 Standard Specification for     Withdrawn and replaced
                                               Acrylic Bone Cement                         with newer version
----------------------------------------------------------------------------------------------------------------
H. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-34                   .....................  ISO 4074:2002/Cor.1:2003(E):, Natural       Relevant guidance
                                               Latex Rubber Condoms--Requirements and
                                               Test Methods, Technical Corrigendum 1
----------------------------------------------------------------------------------------------------------------
9-41                   9-58                   ASTM D6324-08 Standard Test Methods for     Withdrawn and replaced
                                               Male Condoms Made from Polyurethane         with newer version
----------------------------------------------------------------------------------------------------------------
9-43                   .....................  ISO 16038:2005 Rubber condoms--Guidance on  Relevant guidance
                                               the Use of ISO 4074 in the Quality
                                               Management of Natural Rubber Latex
                                               Condoms
----------------------------------------------------------------------------------------------------------------
9-56                   .....................  ASTM D3492-08 Standard Specification for    Relevant guidance
                                               Rubber Contraceptives (Male Condoms)
----------------------------------------------------------------------------------------------------------------
9-57                   .....................  ISO 4074:2002/Cor.2:2008(E) Natural Latex   Relevant guidance
                                               Rubber Condoms--Requirements and Test
                                               Methods, Technical Corrigendum 2
----------------------------------------------------------------------------------------------------------------
I. Orthopedics
----------------------------------------------------------------------------------------------------------------
11-172                 11-211                 ASTM F1798-97 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Guide for Evaluating the Static and         with newer version
                                               Fatigue Properties of Interconnection
                                               Mechanisms and Subassemblies Used in
                                               Spinal Arthrodesis Implants
----------------------------------------------------------------------------------------------------------------
11-178                 11-212                 ASTM F1440-92 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Practice for Cyclic Fatigue Testing of      with newer version
                                               Metallic Stemmed Hip Arthroplasty Femoral
                                               Components Without Torsion
----------------------------------------------------------------------------------------------------------------
11-192                 11-213                 ASTM F1223-08 Standard Test Method for      Withdrawn and replaced
                                               Determination of Total Knee Replacement     with newer version
                                               Constraint
----------------------------------------------------------------------------------------------------------------
11-198                 11-214                 ASTM F0382-99 (Reapproved 2008) Standard    Withdrawn and replaced
                                               Specification and Test Method for           with newer version
                                               Metallic Bone Plates
----------------------------------------------------------------------------------------------------------------
11-204                 11-215                 ASTM F897-02 (Reapproved 2007) Standard     Withdrawn and replaced
                                               Test Method for Measuring Fretting          with newer version
                                               Corrosion of Osteosynthesis Plates and
                                               Screws
----------------------------------------------------------------------------------------------------------------
11-205                 11-216                 ASTM F1264-03 (Reapproved 2007)1 Standard   Withdrawn and replaced
                                               Specification and Test Methods for          with newer version
                                               Intramedullary Fixation Devices
----------------------------------------------------------------------------------------------------------------
11-209                 11-217                 ASTM F2083-081 Standard Specification for   Withdrawn and replaced
                                               Total Knee Prosthesis                       with newer version
----------------------------------------------------------------------------------------------------------------
J. Radiology
----------------------------------------------------------------------------------------------------------------
12-17                  12-192                 NEMA MS 8-2008 Characterization of the      Withdrawn and replaced
                                               Specific Absorption Rate for Magnetic       with new version
                                               Resonance Imaging Systems
----------------------------------------------------------------------------------------------------------------
12-48                  12-193                 AIUM AOL 2008 Acoustic Output Labeling      Withdrawn and replaced
                                               Standard for Diagnostic Ultrasound          with newer version
                                               Equipment Revision 1- A Standard for How
                                               Manufacturers Should Specify Acoustic
                                               Output Data
----------------------------------------------------------------------------------------------------------------
12-58                  12-194                 ANSI/HPS N43.6-2007 Sealed Radioactive      Withdrawn and replaced
                                               Sources--Classification                     with newer version
----------------------------------------------------------------------------------------------------------------
12-69                  12-195                 NEMA MS 6-2008 Determination of Signal-to-  Withdrawn and replaced
                                               Noise Ratio and Image Uniformity for        with newer version
                                               Single-Channel Non-Volume Coils in
                                               Diagnostic MR Imaging
----------------------------------------------------------------------------------------------------------------
12-95                  12-196                 NEMA MS 2-2008 Determination of Two-        Withdrawn and replaced
                                               Dimensional Geometric Distortion in         with newer version
                                               Diagnostic Magnetic Resonance Images
----------------------------------------------------------------------------------------------------------------
12-100                 .....................  NEMA UD 3-2004 Standard for Real Time       Contact person
                                               Display of Thermal and Mechanical
                                               Acoustic Output Indices on Diagnostic
                                               Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------

[[Page 46211]]


12-105                 .....................  NEMA UD 2-2004 Acoustic Output Measurement  Contact person
                                               Standard for Diagnostic Ultrasound
                                               Equipment Version 3
----------------------------------------------------------------------------------------------------------------
12-139                 .....................  AIUM AOMS-2004 Acoustic Output Measurement  Title and Contact
                                               Standard for Diagnostic Ultrasound          person
                                               Equipment
----------------------------------------------------------------------------------------------------------------
12-140                 .....................  AIUM RTD1-2004 Standard for Real-Time       Title and Contact
                                               Display of Thermal and Mechanical           person
                                               Acoustic Output Indices on Diagnostic
                                               Ultrasound Equipment Revision 1
----------------------------------------------------------------------------------------------------------------
12-146                 .....................  IEC 60601-2-17 (2004) Medical Electrical    Title
                                               Equipment--Part 2-17: Particular
                                               Requirements for the Safety of
                                               Automatically-controlled Brachytherapy
                                               Afterloading Equipment
----------------------------------------------------------------------------------------------------------------
12-147                 .....................  IEC 60601-2-5: (2000) Medical Electrical    Title
                                               Equipment--Part 2-5: Particular
                                               Requirements for the Safety of Ultrasonic
                                               Physiotherapy Equipment Ed. 2.0
----------------------------------------------------------------------------------------------------------------
12-169                 12-197                 IEC 60601-2-22 (1995) Medical Electrical    Withdrawn and re-
                                               Equipment--Part 2-22: Particular            recognized previous
                                               Requirements for Basic Safety and           version
                                               Essential Performance of Surgical,
                                               Cosmetic, Therapeutic and Diagnostic
                                               Laser Equipment--Edition 2.0
----------------------------------------------------------------------------------------------------------------
12-178                 .....................  IEC 60601-2-45 Ed. 2.0, (2001), Medical     Title
                                               electrical equipment--Part 2-45:
                                               Particular requirements for the safety of
                                               mammographic X-ray equipment and
                                               mammographic stereotactic devices
----------------------------------------------------------------------------------------------------------------
12-182                 12-198                 IEC 60601-2-37 (2004), (2005) Amendment 2,  Withdrawn and re-
                                               Medical Electrical Equipment--Part 2-37:    recognized previous
                                               Particular Requirements for the Safety of   version
                                               Ultrasonic Medical Diagnostic and
                                               Monitoring Equipment
----------------------------------------------------------------------------------------------------------------
12-185                 12-199                 IEC 60601-1-3: 1994 Medical Electrical      Withdrawn and re-
                                               Equipment--Part 1: General Requirements     recognize previous
                                               for Safety 3. Collateral Standard:          version
                                               General Requirements for Radiation
                                               Protection in Diagnostic X-ray Equipment--
                                               First Edition
----------------------------------------------------------------------------------------------------------------
12-186                 12-200                 IEC 60601-2-29 (1999) Medical Electrical    Withdrawn and re-
                                               Equipment Part 2-29: Particular             recognized previous
                                               Requirements for the Safety of              version
                                               Radiotherapy Simulators--Second Edition
----------------------------------------------------------------------------------------------------------------
K. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-16                  13-29                  CLSI LIS01-A2 Specification for Low-Level   Withdrawn and replaced
                                               Protocol to Transfer Messages Between       with newer version
                                               Clinical Laboratory Instruments and
                                               Computer Systems
----------------------------------------------------------------------------------------------------------------
L. Sterility
----------------------------------------------------------------------------------------------------------------
14-55                  .....................  ANSI/AAMI/ISO 14160:1998/(R) 2008           Reaffirmation
                                               Sterilization of Single-use Medical
                                               Devices Incorporating Materials of Animal
                                               Origin--Validation and Routine Control of
                                               Sterilization by Liquid Chemical
                                               Sterilants
----------------------------------------------------------------------------------------------------------------
14-88                  .....................  ANSI/AAMI/ ISO 14937:2000 Sterilization of  Contact person
                                               Health Care Products--General
                                               Requirements for Characterization of a
                                               Sterilizing Agent and the Development,
                                               Validation, and Routine Control of a
                                               Sterilization Process for Medical
                                               Devices.
----------------------------------------------------------------------------------------------------------------
14-116                 .....................  ANSI/AAMI ST72:2002 Bacterial Endotoxins--  Relevant guidance and
                                               Test Methodologies, Routine Monitoring,     Extent of recognition
                                               and Alternatives to Batch Testing
----------------------------------------------------------------------------------------------------------------
14-135                 .....................  ANSI/AAMI ST63:2002 Sterilization of        Relevant Guidance
                                               Health Care Products--Requirements for
                                               the Development, Validation, and Routine
                                               Control of an Industrial Sterilization
                                               Process for Medical Devices--Dry Heat
----------------------------------------------------------------------------------------------------------------
14-164                 .....................  ANSI/AAMI ST81:2004 Sterilization of        Contact Person
                                               Medical Devices--Information to be
                                               Provided by the Manufacturer for the
                                               Processing of Resterilizable Medical
                                               Devices
----------------------------------------------------------------------------------------------------------------
14-195                 .....................  ANSI/AAMI/ISO 11140-1:2005 Sterilization    Relevant Guidance,
                                               of Health Care Products--Chemical           Extent of Recognition
                                               Indicators--Part 1: General Requirements    and Contact person
----------------------------------------------------------------------------------------------------------------

[[Page 46212]]


14-220                 14-263                 ANSI/AAMI ST79:2006/A1:2008 Comprehensive   Withdrawn and replaced
                                               Guide to Steam Sterilization and            with newer version
                                               Sterility Assurance in Health Care
                                               Facilities
----------------------------------------------------------------------------------------------------------------
14-223                 .....................  ANSI/AAMI/ISO 11138-1:2006 Sterilization    Relevant Guidance
                                               of Health Care Products--Biological
                                               Indicators--Part 1: General Requirements
----------------------------------------------------------------------------------------------------------------
14-224                 .....................  ANSI/AAMI/ISO 11137-1:2006 Sterilization    Relevant Guidance
                                               of Health Care Products--Radiation--Part
                                               1: Requirements for Development,
                                               Validation, and Routine Control of a
                                               Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------
14-225                 .....................  ANSI/AAMI/ISO 11137-2:2006 Sterilization    Relevant Guidance
                                               of Health Care Products--Radiation--Part
                                               2: Establishing the Sterilization Dose
----------------------------------------------------------------------------------------------------------------
14-226                 .....................  ANSI/AAMI/ISO 11137-3:2006 Sterilization    Relevant Guidance
                                               of Health Care Products--Radiation--Part
                                               3: Guidance on Dosimetric Aspects
----------------------------------------------------------------------------------------------------------------
14-228                 .....................  ANSI/AAMI/ISO 11135-1:2007 Sterilization    Relevant Guidance
                                               of Health Care Products--Ethylene oxide--
                                               Part 1: Requirements for Development,
                                               Validation, and Routine Control of a
                                               Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------
14-261                 .....................  ANSI/AAMI/ISO 17665-1:2006 Sterilization    Relevant Guidance
                                               of Health Care Products--Moist Heat--Part
                                               1: Requirements for the Development,
                                               Validation, and Routine Control of a
                                               Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------
14-119                 .....................  ANSI/AAMI ST55:2003/(R)2008 Table-top       Reaffirmation
                                               Steam Sterilizers
----------------------------------------------------------------------------------------------------------------
14-71                  14-264                 ANSI/AAMI ST8:2008 Hospital Steam           Withdrawn and replaced
                                               Sterilizers                                 with newer version
----------------------------------------------------------------------------------------------------------------
14-249                 14-265                 USP 32:2009 <61> Microbiological            Withdrawn and replaced
                                               Examination of Nonsterile Products:         with newer version
                                               Microbial Enumeration Tests
----------------------------------------------------------------------------------------------------------------
14-250                 14-266                 USP 32:2009 <71> Sterility Tests            Withdrawn and replaced
                                                                                           with newer version
----------------------------------------------------------------------------------------------------------------
14-251                 14-267                 USP 32:2009 <85> Bacterial Endotoxins Test  Withdrawn and replaced
                                                                                           with newer version
----------------------------------------------------------------------------------------------------------------
14-252                 14-268                 USP 32:2009 <151> Pyrogen Test (USP Rabbit  Withdrawn and replaced
                                               Test)                                       with newer version
----------------------------------------------------------------------------------------------------------------
14-253                 14-269                 USP 32:2009 <161> Transfusion and Infusion  Withdrawn and replaced
                                               Assemblies and Similar Medical Devices      with newer version
----------------------------------------------------------------------------------------------------------------
14-254                 14-270                 USP 32:2009 Biological Indicator for Steam  Withdrawn and replaced
                                               Sterilization--Self Contained               with newer version
----------------------------------------------------------------------------------------------------------------
14-246                 14-271                 USP 32:2009 Biological Indicator for Dry-   Withdrawn and replaced
                                               Heat Sterilization, Paper Carrier           with newer version
----------------------------------------------------------------------------------------------------------------
14-247                 14-272                 USP 32:2009 Biological Indicator for        Withdrawn and replaced
                                               Ethylene Oxide Sterilization, Paper         with newer version
                                               Carrier
----------------------------------------------------------------------------------------------------------------
14-248                 14-273                 USP 32:2009 Biological Indicator for Steam  Withdrawn and replaced
                                               Sterilization, Paper Carrier                with newer version
----------------------------------------------------------------------------------------------------------------
14-238                 .....................  ANSI/AAMI/ISO 11140-5:2007 Sterilization    Contact person and
                                               of Health Care Products--Chemical           Relevant guidance
                                               Indicators--Part 5: Class 2 Indicators
                                               for Bowie and Dick-type Air Removal Tests
----------------------------------------------------------------------------------------------------------------
14-171                 14-274                 ANSI/AAMI/ISO 15882:2008 Chemical           Withdrawn and replaced
                                               Indicators--Guidance on the Selection,      with newer version
                                               Use, and Interpretation of Results
----------------------------------------------------------------------------------------------------------------
14-49                  14-275                 ANSI/AAMI ST41:2008 Ethylene oxide          Withdrawn and replaced
                                               Sterilization in Health Care Facilities:    with newer version
                                               Safety and Effectiveness
----------------------------------------------------------------------------------------------------------------
14-136                 .....................  ANSI/AAMI ST67:2003/(R) 2008 Sterilization  Reaffirmation and
                                               of Health Care Products--Requirements for   Relevant guidance
                                               Products Labeled ``STERILE''
----------------------------------------------------------------------------------------------------------------


[[Page 46213]]

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: 022.

                                                    Table 3.
----------------------------------------------------------------------------------------------------------------
    Recognition No.                           Title of Standard                          Reference No. & Date
----------------------------------------------------------------------------------------------------------------
A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-152                   Biological Evaluation of Medical Devices--Part 10: Tests for  ISO 10993 10:2002/
                         Irritation and Delayed-type Hypersensitivity Amendment 1      Amd.1:2006(E)
----------------------------------------------------------------------------------------------------------------
B. General
----------------------------------------------------------------------------------------------------------------
5-46                    Sampling Procedures for Inspection by Attributes--Part 1:     ISO 2859-1:1999/Cor 1:2001
                         Sampling Schemes Indexed by Acceptance Quality Limit (AQL)
                         for Lot-by-lot Inspection
----------------------------------------------------------------------------------------------------------------
5-50                    Medical Devices--Application of Usability Engineering to      IEC 62366:2007
                         Medical Devices
----------------------------------------------------------------------------------------------------------------
C. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-204                   Reference Method for Broth Dilution Antifungal                CLSI M27-A3
                         Susceptibility Testing of Yeasts
----------------------------------------------------------------------------------------------------------------
D. Materials
----------------------------------------------------------------------------------------------------------------
8-186                   Standard Guide for Assessment of the Ultra High Molecular     ASTM F 2759--09
                         Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal
                         Devices
----------------------------------------------------------------------------------------------------------------
8-187                   Implants for Surgery--Hydroxyapatite--Part 1: Ceramic         ISO 13779-1:2008(E)
                         Hydroxyapatite
----------------------------------------------------------------------------------------------------------------
8-188                   Implants for Surgery--Hydroxyapatite--Part 2: Coatings of     ISO 13779-2:2008(E)
                         Hydroxyapatite
----------------------------------------------------------------------------------------------------------------
E. Neurology
----------------------------------------------------------------------------------------------------------------
17-8                    Implants for Surgery--Active Implantable Medical Devices      ISO 14708-3 2008-11-15
                         Part 3: Implantable Neurostimulators (Neurology)
----------------------------------------------------------------------------------------------------------------
F. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-59                    Hemodialysis Systems                                          ANSI/AAMI RD5:2003/(R)
                                                                                       2008
----------------------------------------------------------------------------------------------------------------
G. Orthopedics
----------------------------------------------------------------------------------------------------------------
11-218                  Implants for surgery--Wear of Total Knee-joint Prostheses--   ISO 14243-3:2004 Technical
                         Part 3: Loading and Displacement Parameters for Wear-         Corrigendum 1
                         testing Machines with Displacement Control and
                         Corresponding Environmental Conditions for Test
----------------------------------------------------------------------------------------------------------------
H. Sterility
----------------------------------------------------------------------------------------------------------------
14-276                  Sterilization of Health Care Products--Moist Heat--Part 2:    ISO/TS 17665-2:2009
                         Guidance on the Application of ISO 17665-1
----------------------------------------------------------------------------------------------------------------
14-277                  Microbiological Examination of Nonsterile Products: Tests     USP32:2009 <62>
                         for Specified Microorganisms
----------------------------------------------------------------------------------------------------------------
14-278                  Biological Evaluation of Medical Devices--Part 7: Ethylene    ANSI/AAMI/ISO 10993-7:2008
                         Oxide Sterilization Residuals
----------------------------------------------------------------------------------------------------------------
I. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-14                   Standard Guide for Interpreting Images of Polymeric Tissue    ASTM F2603-06
                         Scaffolds
----------------------------------------------------------------------------------------------------------------
15-15                   Standard Test Method for Determining the Chemical             ASTM F2259-03 (Reapproved
                         Composition and Sequence in Alginate by Proton Nuclear        2008)
                         Magnetic Resonance (1H NMR) Spectroscopy
----------------------------------------------------------------------------------------------------------------

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.

[[Page 46214]]

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: 022'' 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: 022. These modifications 
to the list or recognized standards are effective upon publication of 
this document in the Federal Register.

    Dated: August 26, 2009.
Catherine M. Cook,
Associate Director for Regulation and Policy.
[FR Doc. E9-21609 Filed 9-4-09; 8:45 am]

BILLING CODE 4160-01-S
