Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2004-N-0451] (formerly Docket No. 2004N-0226)
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 023” (Recognition List Number: 023), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
 DATES: Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.
 ADDRESSES: Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 023” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, 
                        ( print page 24712)
                        rm. 4613, Silver Spring, MD 20993-0002. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-847-8149. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see 
                        **FOR FURTHER INFORMATION CONTACT**
                        ). Submit electronic comments by e-mail: 
                        *standards@cdrh.fda.gov*. This document may also be accessed on FDA's Internet site at 
                        *http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfTopic/​cdrhnew.cfm*. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 023 modifications and other standards related information.
 FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301-796-6574.


SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the 
                    **Federal Register**
                     of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the 
                    **Federal Register**
                    , are identified in table 1 of this document. **Table 1.—Previous Publications of Standard Recognition Lists**
February 25, 1998 (63 FR 9561)
May 27, 2005 (70 FR 30756)October 16, 1998 (63 FR 55617)
November 8, 2005 (70 FR 67713)July 12, 1999 (64 FR 37546)
March 31, 2006 (71 FR 16313)November 15, 2000 (65 FR 69022)
June 23, 2006 (71 FR 36121)May 7, 2001 (66 FR 23032)
November 3, 2006 (71 FR 64718)January 14, 2002 (67 FR 1774)
May 21, 2007 (72 FR 28500)October 2, 2002 (67 FR 61893)
September 12, 2007 (72 FR 52142)April 28, 2003 (68 FR 22391)
December 19, 2007 (72 FR 71924)March 8, 2004 (69 FR 10712)
September 9, 2008 (73 FR 52358)June 18, 2004 (69 FR 34176)
March, 18, 2009 (74 FR 11586)October 4, 2004 (69 FR 59240)
September 8, 2009 (74 FR 46203)
 These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language (HTML)” and “portable document format (PDF)” versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 023 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency's searchable database. FDA will use the term “Recognition List Number: 023” to identify these current modifications. In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA. **Table 2.—Modifications to the List of Recognized Standards**
Old Recognition No.
Replacement Recognition No.
Standard
ChangeA. Biocompatibility2-64
2-153
ANSI/AAMI/ISO 10993-5:2009 Biological Evaluation of Medical Devices—Part 5: Tests for 
                            *in vitro*
                             Cytotoxicity
Withdrawn and replaced with newer version2-67
2-154
ASTM F756—08 Standard Practice for Assessment of Hemolytic Properties of Materials
Withdrawn and replaced with newer version2-82
2-155
ASTM F2147-01 (Reapproved 2006) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
Withdrawn and replaced with newer version2-87

ISO 10993-10:2002 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-Type Hypersensitivity
Title, Extent of recognition, and Relevant guidance2-93

ASTM F 763—04 Standard Practice for Short-Term Screening of Implant Materials
Extent of recognition( print page 24713)2-94

ASTM F 981—04 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
Extent of recognition2-96

ASTM F 1903—98 (Reapproved 2003) Standard Practice for Testing For Biological Responses to Particles 
                            *in vitro*
Title and Extent of recognition2-98

ANSI/ AAMI/ ISO 10993-1:2003 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing
Title, Extent of recognition, and Relevant guidance2-100

ASTM E 1372—95 (Reapproved 2003) Standard Test Method for Conducting a 90-Day Oral Toxicity Study in Rats
Title and Extent of recognition2-108

ASTM F 1905—98 (Reapproved 2003) Standard Practice For Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
Title and Extent of recognition2-114

ASTM F 1877—05 Standard Practice for Characterization of Particles
Extent of recognition2-115

ASTM F 895—84 (Reapproved 2006) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
Title, Extent of recognition, and Relevant guidance2-117

ANSI/AAMI/ISO 10993-3:2003 Biological Evaluation of Medical Devices—Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
Title, Extent of recognition, and contact person2-118

ANSI/AAMI/ISO 10993-11:2006 Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity
Title, Extent of recognition, and Relevant guidance2-119

ASTM F813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
Extent of recognition2-120

ANSI/AAMI/ISO 10993-6:2007 Biological Evaluation of Medical Devices—Part 6: Tests for Local Effects after Implantation
Title and Extent of recognition2-122

ASTM F 719-81 (Reapproved 2007)
                            e
                             Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
Title, Extent of recognition, and Relevant guidance2-123

ASTM F 720-81 (Reapproved 2007) Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
Title, Extent of recognition, and Relevant guidance2-124

ASTM F 750-87 (Reapproved 2007)
                            e
                             Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
Title, Extent of recognition, and Relevant guidance2-125

ASTM F749-98 (Reapproved 2007)
                            e1
                             Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
Title, Extent of recognition, and Relevant guidance2-126

ASTM F748-06 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Extent of recognition and Relevant guidance2-133

ASTM F1408-97 (Reapproved 2008) Standard Practice for Subcutaneous Screening Test for Implant Materials
Extent of recognition2-134

ASTM F2065-00 (Reapproved 2006) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
Extent of recognition2-135

ANSI/ AAMI/ ISO 10993-12:2007 Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference Materials
Title, Extent of recognition, and Relevant guidance2-136

ASTM E1262-88 (Reapproved 2008) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
Title, Extent of recognition, and Relevant guidance2-137

ASTM E1263-97 (Reapproved 2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
Extent of recognition2-138

ASTM E1280-97 (Reapproved 2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity
Extent of recognition and Relevant guidance2-139

ASTM E1397-91 (Reapproved 2008) Standard Practice for the 
                            *In Vitro*
                             Rat Hepatocyte DNA Repair Assay
Extent of recognition( print page 24714)2-140

ASTM E1398-91 (Reapproved 2008) Standard Practice for the 
                            *In Vivo*
                             Rat Hepatocyte DNA Repair Assay
Extent of recognition2-141

ASTM F1984-99 (Reapproved 2008) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
Extent of recognition, Relevant guidance and Contact person2-142

ASTM F1983-99 (Reapproved 2008) Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
Extent of recognition2-143

ASTM F1904-98 (Reapproved 2008) Standard Practice for Testing the Biological Responses to Particles 
                            *in vivo*
Extent of recognition2-144

ASTM F619-03 (Reapproved 2008) Standard Practice for Extraction of Medical Plastics
Extent of recognition and Relevant guidance2-145

ASTM F1439-03 (Reapproved 2008) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
Extent of recognition2-146

ASTM F2148-07
                            e1
                             Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
Extent of recognition and Relevant guidance2-147

USP 32-NF26 Biological Tests <87> 2009 Biological Reactivity Test, In Vitro—Direct Contact Test
Extent of recognition and Relevant guidance2-148

USP 32-NF26 Biological Tests <87> Biological Reactivity Test, In Vitro—Elution Test
Extent of recognition and Relevant guidance2-149

USP 32-NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo, Procedure—Preparation of Sample
Extent of recognition and Relevant guidance2-150

USP 32-NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Intracutaneous Test
Extent of recognition and Relevant guidance2-151

USP 32-NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection Test
Extent of recognition and Relevant guidance2-152

ISO 10993-10:2002/Amd.1:2006(E) Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-Type Hypersensitivity AMENDMENT 1
Extent of recognition and Relevant guidanceB. Cardiology3-2
3-72
ANSI/AAMI EC53:1995/(R) 2008 ECG Cables and Leadwires
Withdrawn and replaced with newer version3-29

IEC 60601-2-30 (1999-12) Medical Electrical Equipment, Part 2: Particular Requirements for the Safety, Including Essential Performance, of Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment
Withdrawn3-45
3-73
ANSI/AAMI/ISO EC57:1998/(R)2008 Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms
Withdrawn and replaced with newer version3-49
3-74
ASTM F2079-02 (Reapproved 2008) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents1
Withdrawn and replaced with newer version3-50

AAMI/ANSI DF2-1996 (Revision of ANSI/AAMI DF2-1989) Cardiac Defibrillator Devices
Withdrawn3-51

AAMI /ANSI DF-39-1993 Automatic External Defibrillators and Remote-Control Defibrillators
Withdrawn3-53
3-75
ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008, ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Manual, Electronic, or Automated Sphygmomanometers
Withdrawn and replaced with newer version( print page 24715)3-63

ISO 11318:2002 Cardiac Defibrillators—Connector Assembly DF-1 for Implantable Defibrillators—Dimensions and Test Requirements
Contact person3-67
3-76
ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Withdrawn and replaced with newer version3-70

AAMI/ANSI SP10:2002/A1:2003—Amendment 1 to ANSI/AAMI SP10:2002 Manual, Electronic, or Automated Sphygmomanometers
Withdrawn3-71

AAMI/ANSI SP10:2002/A2:2006—Amendment 2 to ANSI/AAMI SP10:2002 Manual, Electronic, or Automated Sphygmomanometers
WithdrawnC. Dental/ENT4-78
4-180
ISO 9168:2009 Dentistry—Hose Connectors for Air Driven Dental Handpieces
Withdrawn and replaced with newer version4-87

ADA/ANSI ADA Specification No. 69 - Dental Ceramic:1999
Reaffirmation4-91

ADA/ANSI ADA Specification No. 80 - Dental Material-Determination of Color Stability:2001
Reaffirmation4-99
4-181
ISO 4049:2009 Dentistry-Polymer-Based Filling, Restorative and Luting Materials
Withdrawn and replaced with newer version4-117

ADA/ANSI Specification No. 12 - Denture Base Polymers:2002
Reaffirmation4-119

ADA/ANSI Specification No. 82 - Dental Reversible/Irreversible Hydrocolloid Impression Material Systems: 1998/Reaffirmed 2003
Reaffirmation4-120
4-182
ISO 10139-2:2009 Dentistry—Soft Lining Materials for Removable Dentures—Part 2: Materials for Long-Term Use
Withdrawn and replaced with newer version4-160

ANSI/ASA S3.1-1999 (R 2003) Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
Reaffirmation4-161
4-183
ANSI/ASA S3.2-2009 Method for Measuring the Intelligibility of Speech Over Communication Systems
Withdrawn and replaced with newer version4-164

ANSI/ASA S3.7-1995 (R 2003) Method for Coupler Calibration of Earphones
Reaffirmation4-166

ANSI/ASA S3.20-1995 (R2003) Bioacoustical Terminology
Reaffirmation4-167

ANSI/ASA S3.21-2004 Methods for Manual Pure-Tone threshold Audiometry
Reaffirmation4-168
4-184
ANSI/ASA S3.25-2009 Occluded Ear Simulator
Withdrawn and replaced with newer version4-174
4-185
ANSI/ASA S3.45-2009 Procedures for Testing Basic Vestibular Function
Withdrawn and replaced with newer version4-176
4-186
ANSI/ASA S12.2-2008 Criteria for Evaluating Room Noise
Withdrawn and replaced with newer versionD. General5-18
5-51
ASTM D-4332-01 (Reapproved 2006) Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
Withdrawn and replaced with newer version5-29

AAMI/ANSI HE74-2001/ Human Factors Design Process for Medical Devices
ReaffirmationE. In Vitro Diagnostics7-35
7-205
CLSI H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test
Withdrawn and replaced with newer version( print page 24716)7-42
7-206
CLSI I/LA20-A2 Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities
Withdrawn and replaced with newer version7-97
7-207
CLSI GP16-A3 Urinalysis
Withdrawn and replaced with newer version7-187
7-208
CLSI M44-S2 Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts
Withdrawn and replaced with newer version7-37

NCCLS I/LA06-A Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Specimen Handling, and Use of Test Products in the Clinical Laboratory
WithdrawnF. Materials8-104
8-189
ASTM F 1108—04 (Reapproved 2009) Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
Withdrawn and replaced with newer version8-145
8-190
ASTM F 90-09 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
Withdrawn and replaced with newer versionG. Physical Medicine16-19
16-162
ISO 7176-4:2008 Wheelchairs—Part 4: Energy Consumption of Electric Wheelchairs and Scooters for Determination of Theoretical Distance Range
Withdrawn and replaced with newer version16-20
16-163
ISO 7176-5:2008 Wheelchairs—Part 5: Determination of Dimensions, Mass and Manoeuvring Space
Withdrawn and replaced with newer version16-23
16-164
ISO 7176-10:2008 Wheelchairs—Part 10: Determination of Obstacle-Climbing Ability of Electrically Powered Wheelchairs
Withdrawn and replaced with newer version16-26
16-165
ISO 7176-14:2008 Wheelchairs—Part 14 Power and Control Systems for Electrically Powered Wheelchairs and Scooters—Requirements and Test Methods
Withdrawn and replaced with newer versionH. Sterility14-117

ANSI/AAMI ST35:2003 Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings
Withdrawn14-263
14-280
ANSI/AAMI ST79:2006 and A1:2008, A2:2009 (Consolidated Text) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
Withdrawn and replaced with newer version14-256
14-286
ASTM F2095-07e1 Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
Withdrawn and replaced with newer version14-255
14-281
ASTM F17-08 Standard Terminology Relating to Flexible Barrier Packaging1
Withdrawn and replaced with newer version14-245
14-282
ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method1
Withdrawn and replaced with newer version14-237
14-283
ASTM F 88/F 88M—09 Standard Test Method for Seal Strength of Flexible Barrier Materials1
Withdrawn and replaced with newer version14-199
14-284
ASTM D4169-08 Standard Practice for Performance Testing of Shipping Containers and Systems1
Withdrawn and replaced with newer version14-228

ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health Care Products - Ethylene oxide - Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
Guidance( print page 24717)14-70
14-285
ANSI/AAMI/ISO 14161:2009 Sterilization of Health Care Products - Biological Indicators - Guidance for the Selection, Use and Interpretation of Results
Withdrawn and replaced with newer versionI. Tissue Engineering15-6
15-16
ASTM F2450-09 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products1
Withdrawn and replaced with newer version15-9
15-17
ASTM F2311-08 Standard Guide for Classification of Therapeutic Skin Substitutes1
Withdrawn and replaced with newer version15-13
15-18
ASTM F2212-09 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)1
Withdrawn and replaced with newer version
 III. Listing of New Entries In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 023. **Table 3.—New Entries to the List of Recognized Standards**
Recognition No.
Title of Standard
Reference No. & DateA. Cardiology3-77
Active Implantable Medical Devices—Electromagnetic Compatibility—EMC Test Protocols for Implantable Cardiac Pacemakers and Implantable Cardioverter Defibrillators
ANSI/AAMI PC69:2007B. In Vitro Diagnostics7-209
Performance Metrics for Continuous Interstitial Glucose Monitoring
POCT 05-AC. Orthopedics11-219
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
ASTM F 2026-08D. Physical Medicine16-166
Wheelchairs—Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters, and Battery Chargers
ISO 7176-21:2009E. Sterility14-286
Processing of Reusable Surgical Textiles for Use in Health Care Facilities
ANSI/AAMI ST65:2008
 IV. List of Recognized Standards FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at 
                    *http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfStandards/​search.cfm*. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the 
                    **Federal Register**
                    , this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the 
                    **Federal Register**
                     once a year, or more often, if necessary. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (See 
                    **FOR FURTHER INFORMATION CONTACT**
                    ). To be properly considered such recommendations should contain, at a minimum, the following information: (1) title of the standard; (2) any reference number and date; (3) name and address of the national or international standards development organization; (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply; and (5) a brief identification of the testing or performance or other characteristics of the devices that would be addressed by a declaration of conformity. VI. Electronic Access You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal 
                    ( print page 24718)
                    computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the 
                    **Federal Register**
                    , this notice announcing “Modification to the List of Recognized Standards, Recognition List Number: 023” will be available on the CDRH home page. You may access the CDRH home page at 
                    *http://www.fda.gov/​cdrh*. You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” through the hyperlink at 
                    *http://www.fda.gov/​cdrh/​stdsprog.html*. This 
                    **Federal Register**
                     document on modifications in FDA's recognition of consensus standards is available at 
                    *http://www.fda.gov/​cdrh/​fedregin.html*. VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see 
                    **FOR FURTHER INFORMATION CONTACT**
                    ) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 023. These modifications to the list or recognized standards are effective upon publication of this notice in the 
                    **Federal Register**
                    . Dated: April 30, 2010. Leslie Kux, Acting Assistant Commissioner for Policy.


[FR Doc. 2010-10562 Filed 5-4-10; 8:45 am] BILLING CODE 4160-01-S