Food and Drug Administration Modernization Act of 1997: Modifications to List of Recognized Standards (Recognition List Number 023)

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Federal Register: May 5, 2010 (Volume 75, Number 86)

Notices

Page 24711-24718

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr05my10-102

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2004-N-0451

(formerly Docket No. 2004N-0226)

Food and Drug Administration Modernization Act of 1997:

Modifications to the List of Recognized Standards, Recognition List

Number: 023

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled

``Modifications to the List of Recognized Standards, Recognition List

Number: 023'' (Recognition List Number: 023), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES: Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.

ADDRESSES: Submit written requests for single copies of

``Modifications to the List of Recognized Standards, Recognition List

Number: 023'' to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health,

Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66,

Page 24712

rm. 4613, Silver Spring, MD 20993-0002. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-847-8149. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION

CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.gov.

This document may also be accessed on FDA's Internet site at http:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 023 modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New

Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301- 796-6574.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal

Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

In a notice published in the Federal Register of February 25, 1998

(63 FR 9561), FDA announced the availability of a guidance entitled

``Recognition and Use of Consensus Standards.'' The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards.

Modifications to the initial list of recognized standards, as published in the Federal Register, are identified in table 1 of this document.

Table 1.--Previous Publications of Standard Recognition Lists

February 25, 1998 (63 FR 9561)

May 27, 2005 (70 FR 30756)

October 16, 1998 (63 FR 55617)

November 8, 2005 (70 FR 67713)

July 12, 1999 (64 FR 37546)

March 31, 2006 (71 FR 16313)

November 15, 2000 (65 FR 69022)

June 23, 2006 (71 FR 36121)

May 7, 2001 (66 FR 23032)

November 3, 2006 (71 FR 64718)

January 14, 2002 (67 FR 1774)

May 21, 2007 (72 FR 28500)

October 2, 2002 (67 FR 61893)

September 12, 2007 (72 FR 52142)

April 28, 2003 (68 FR 22391)

December 19, 2007 (72 FR 71924)

March 8, 2004 (69 FR 10712)

September 9, 2008 (73 FR 52358)

June 18, 2004 (69 FR 34176)

March, 18, 2009 (74 FR 11586)

October 4, 2004 (69 FR 59240)

September 8, 2009 (74 FR 46203)

These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains ``hypertext markup language (HTML)'' and ``portable document format (PDF)'' versions of the list of ``FDA Recognized Consensus Standards.'' Both versions are publicly accessible at the agency's Internet site. See section VI of this document for electronic access information.

Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List

Number: 023

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices.

FDA will incorporate these modifications in the list of FDA Recognized

Consensus Standards in the agency's searchable database. FDA will use the term ``Recognition List Number: 023'' to identify these current modifications.

In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA.

Table 2.--Modifications to the List of Recognized Standards

Replacement

Old Recognition No.

Recognition No.

Standard

Change

A. Biocompatibility

2-64

2-153

ANSI/AAMI/ISO 10993-5:2009 Biological

Withdrawn and replaced

Evaluation of Medical Devices--Part 5:

with newer version

Tests for in vitro Cytotoxicity

2-67

2-154

ASTM F756--08 Standard Practice for

Withdrawn and replaced

Assessment of Hemolytic Properties of

with newer version

Materials

2-82

2-155

ASTM F2147-01 (Reapproved 2006) Standard

Withdrawn and replaced

Practice for Guinea Pig: Split Adjuvant and with newer version

Closed Patch Testing for Contact Allergens

2-87

................... ISO 10993-10:2002 Biological Evaluation of

Title, Extent of

Medical Devices--Part 10: Tests for

recognition, and

Irritation and Delayed-Type

Relevant guidance

Hypersensitivity

2-93

................... ASTM F 763--04 Standard Practice for Short- Extent of recognition

Term Screening of Implant Materials

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2-94

................... ASTM F 981--04 Standard Practice for

Extent of recognition

Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to

Effect of Materials on Muscle and Bone

2-96

................... ASTM F 1903--98 (Reapproved 2003) Standard

Title and Extent of

Practice for Testing For Biological

recognition

Responses to Particles in vitro

2-98

................... ANSI/ AAMI/ ISO 10993-1:2003 Biological

Title, Extent of

Evaluation of Medical Devices--Part 1:

recognition, and

Evaluation and Testing

Relevant guidance

2-100

................... ASTM E 1372--95 (Reapproved 2003) Standard

Title and Extent of

Test Method for Conducting a 90-Day Oral

recognition

Toxicity Study in Rats

2-108

................... ASTM F 1905--98 (Reapproved 2003) Standard

Title and Extent of

Practice For Selecting Tests for

recognition

Determining the Propensity of Materials to

Cause Immunotoxicity

2-114

................... ASTM F 1877--05 Standard Practice for

Extent of recognition

Characterization of Particles

2-115

................... ASTM F 895--84 (Reapproved 2006) Standard

Title, Extent of

Test Method for Agar Diffusion Cell Culture recognition, and

Screening for Cytotoxicity

Relevant guidance

2-117

................... ANSI/AAMI/ISO 10993-3:2003 Biological

Title, Extent of

Evaluation of Medical Devices--Part 3:

recognition, and

Tests for Genotoxicity, Carcinogenicity,

contact person and Reproductive Toxicity

2-118

................... ANSI/AAMI/ISO 10993-11:2006 Biological

Title, Extent of

Evaluation of Medical Devices--Part 11:

recognition, and

Tests for Systemic Toxicity

Relevant guidance

2-119

................... ASTM F813-07 Standard Practice for Direct

Extent of recognition

Contact Cell Culture Evaluation of

Materials for Medical Devices

2-120

................... ANSI/AAMI/ISO 10993-6:2007 Biological

Title and Extent of

Evaluation of Medical Devices--Part 6:

recognition

Tests for Local Effects after Implantation

2-122

................... ASTM F 719-81 (Reapproved 2007)e Standard

Title, Extent of

Practice for Testing Biomaterials in

recognition, and

Rabbits for Primary Skin Irritation

Relevant guidance

2-123

................... ASTM F 720-81 (Reapproved 2007) Standard

Title, Extent of

Practice for Testing Guinea Pigs for

recognition, and

Contact Allergens: Guinea Pig Maximization

Relevant guidance

Test

2-124

................... ASTM F 750-87 (Reapproved 2007)e Standard

Title, Extent of

Practice for Evaluating Material Extracts

recognition, and by Systemic Injection in the Mouse

Relevant guidance

2-125

................... ASTM F749-98 (Reapproved 2007)e1 Standard

Title, Extent of

Practice for Evaluating Material Extracts

recognition, and by Intracutaneous Injection in the Rabbit

Relevant guidance

2-126

................... ASTM F748-06 Standard Practice for Selecting Extent of recognition

Generic Biological Test Methods for

and Relevant guidance

Materials and Devices

2-133

................... ASTM F1408-97 (Reapproved 2008) Standard

Extent of recognition

Practice for Subcutaneous Screening Test for Implant Materials

2-134

................... ASTM F2065-00 (Reapproved 2006) Standard

Extent of recognition

Practice for Testing for Alternative

Pathway Complement Activation in Serum by

Solid Materials

2-135

................... ANSI/ AAMI/ ISO 10993-12:2007 Biological

Title, Extent of

Evaluation of Medical Devices--Part 12:

recognition, and

Sample Preparation and Reference Materials

Relevant guidance

2-136

................... ASTM E1262-88 (Reapproved 2008) Standard

Title, Extent of

Guide for Performance of Chinese Hamster

recognition, and

Ovary Cell/Hypoxanthine Guanine

Relevant guidance

Phosphoribosyl Transferase Gene Mutation

Assay

2-137

................... ASTM E1263-97 (Reapproved 2008) Standard

Extent of recognition

Guide for Conduct of Micronucleus Assays in

Mammalian Bone Marrow Erythrocytes

2-138

................... ASTM E1280-97 (Reapproved 2008) Standard

Extent of recognition

Guide for Performing the Mouse Lymphoma

and Relevant guidance

Assay for Mammalian Cell Mutagenicity

2-139

................... ASTM E1397-91 (Reapproved 2008) Standard

Extent of recognition

Practice for the In Vitro Rat Hepatocyte

DNA Repair Assay

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2-140

................... ASTM E1398-91 (Reapproved 2008) Standard

Extent of recognition

Practice for the In Vivo Rat Hepatocyte DNA

Repair Assay

2-141

................... ASTM F1984-99 (Reapproved 2008) Standard

Extent of recognition,

Practice for Testing for Whole Complement

Relevant guidance and

Activation in Serum by Solid Materials

Contact person

2-142

................... ASTM F1983-99 (Reapproved 2008) Standard

Extent of recognition

Practice for Assessment of Compatibility of

Absorbable/Resorbable Biomaterials for

Implant Applications

2-143

................... ASTM F1904-98 (Reapproved 2008) Standard

Extent of recognition

Practice for Testing the Biological

Responses to Particles in vivo

2-144

................... ASTM F619-03 (Reapproved 2008) Standard

Extent of recognition

Practice for Extraction of Medical Plastics and Relevant guidance

2-145

................... ASTM F1439-03 (Reapproved 2008) Standard

Extent of recognition

Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant

Materials

2-146

................... ASTM F2148-07e1 Standard Practice for

Extent of recognition

Evaluation of Delayed Contact

and Relevant guidance

Hypersensitivity Using the Murine Local

Lymph Node Assay (LLNA)

2-147

................... USP 32-NF26 Biological Tests 2009

Extent of recognition

Biological Reactivity Test, In Vitro--

and Relevant guidance

Direct Contact Test

2-148

................... USP 32-NF26 Biological Tests Biological Extent of recognition

Reactivity Test, In Vitro--Elution Test

and Relevant guidance

2-149

................... USP 32-NF26 Biological Tests Biological Extent of recognition

Reactivity Tests, In Vivo, Procedure--

and Relevant guidance

Preparation of Sample

2-150

................... USP 32-NF26 Biological Tests Biological Extent of recognition

Reactivity Tests, In Vivo, Classification

and Relevant guidance of Plastics--Intracutaneous Test

2-151

................... USP 32-NF26 Biological Tests Biological Extent of recognition

Reactivity Tests, In Vivo, Classification

and Relevant guidance of Plastics--Systemic Injection Test

2-152

................... ISO 10993-10:2002/Amd.1:2006(E) Biological

Extent of recognition

Evaluation of Medical Devices--Part 10:

and Relevant guidance

Tests for Irritation and Delayed-Type

Hypersensitivity AMENDMENT 1

B. Cardiology

3-2

3-72

ANSI/AAMI EC53:1995/(R) 2008 ECG Cables and Withdrawn and replaced

Leadwires

with newer version

3-29

................... IEC 60601-2-30 (1999-12) Medical Electrical Withdrawn

Equipment, Part 2: Particular Requirements for the Safety, Including Essential

Performance, of Automatic Cycling Non-

Invasive Blood Pressure Monitoring

Equipment

3-45

3-73

ANSI/AAMI/ISO EC57:1998/(R)2008 Testing and Withdrawn and replaced

Reporting Performance Results of Cardiac

with newer version

Rhythm and ST-Segment Measurement

Algorithms

3-49

3-74

ASTM F2079-02 (Reapproved 2008) Standard

Withdrawn and replaced

Test Method for Measuring Intrinsic Elastic with newer version

Recoil of Balloon-Expandable Stents\1\

3-50

................... AAMI/ANSI DF2-1996 (Revision of ANSI/AAMI

Withdrawn

DF2-1989) Cardiac Defibrillator Devices

3-51

................... AAMI /ANSI DF-39-1993 Automatic External

Withdrawn

Defibrillators and Remote-Control

Defibrillators

3-53

3-75

ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI

Withdrawn and replaced

SP10:2002/A1:2003/(R)2008 & ANSI/AAMI

with newer version

SP10:2002/A2:2006/(R)2008, ANSI/AAMI

SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/

A1:2003/(R)2008 & ANSI/AAMI SP10:2002/

A2:2006/(R)2008 Manual, Electronic, or

Automated Sphygmomanometers

Page 24715

3-63

................... ISO 11318:2002 Cardiac Defibrillators--

Contact person

Connector Assembly DF-1 for Implantable

Defibrillators--Dimensions and Test

Requirements

3-67

3-76

ASTM F2129-08 Standard Test Method for

Withdrawn and replaced

Conducting Cyclic Potentiodynamic

with newer version

Polarization Measurements to Determine the

Corrosion Susceptibility of Small Implant

Devices

3-70

................... AAMI/ANSI SP10:2002/A1:2003--Amendment 1 to Withdrawn

ANSI/AAMI SP10:2002 Manual, Electronic, or

Automated Sphygmomanometers

3-71

................... AAMI/ANSI SP10:2002/A2:2006--Amendment 2 to Withdrawn

ANSI/AAMI SP10:2002 Manual, Electronic, or

Automated Sphygmomanometers

C. Dental/ENT

4-78

4-180

ISO 9168:2009 Dentistry--Hose Connectors for Withdrawn and replaced

Air Driven Dental Handpieces

with newer version

4-87

................... ADA/ANSI ADA Specification No. 69 - Dental

Reaffirmation

Ceramic:1999

4-91

................... ADA/ANSI ADA Specification No. 80 - Dental

Reaffirmation

Material-Determination of Color

Stability:2001

4-99

4-181

ISO 4049:2009 Dentistry-Polymer-Based

Withdrawn and replaced

Filling, Restorative and Luting Materials

with newer version

4-117

................... ADA/ANSI Specification No. 12 - Denture Base Reaffirmation

Polymers:2002

4-119

................... ADA/ANSI Specification No. 82 - Dental

Reaffirmation

Reversible/Irreversible Hydrocolloid

Impression Material Systems: 1998/

Reaffirmed 2003

4-120

4-182

ISO 10139-2:2009 Dentistry--Soft Lining

Withdrawn and replaced

Materials for Removable Dentures--Part 2:

with newer version

Materials for Long-Term Use

4-160

................... ANSI/ASA S3.1-1999 (R 2003) Maximum

Reaffirmation

Permissible Ambient Noise Levels for

Audiometric Test Rooms

4-161

4-183

ANSI/ASA S3.2-2009 Method for Measuring the Withdrawn and replaced

Intelligibility of Speech Over

with newer version

Communication Systems

4-164

................... ANSI/ASA S3.7-1995 (R 2003) Method for

Reaffirmation

Coupler Calibration of Earphones

4-166

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

Reaffirmation

Terminology

4-167

................... ANSI/ASA S3.21-2004 Methods for Manual Pure- Reaffirmation

Tone threshold Audiometry

4-168

4-184

ANSI/ASA S3.25-2009 Occluded Ear Simulator

Withdrawn and replaced with newer version

4-174

4-185

ANSI/ASA S3.45-2009 Procedures for Testing

Withdrawn and replaced

Basic Vestibular Function

with newer version

4-176

4-186

ANSI/ASA S12.2-2008 Criteria for Evaluating Withdrawn and replaced

Room Noise

with newer version

D. General

5-18

5-51

ASTM D-4332-01 (Reapproved 2006) Standard

Withdrawn and replaced

Practice for Conditioning Containers,

with newer version

Packages, or Packaging Components for

Testing

5-29

................... AAMI/ANSI HE74-2001/ Human Factors Design

Reaffirmation

Process for Medical Devices

E. In Vitro Diagnostics

7-35

7-205

CLSI H47-A2 One-Stage Prothrombin Time (PT) Withdrawn and replaced

Test and Activated Partial Thromboplastin

with newer version

Time (APTT) Test

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7-42

7-206

CLSI I/LA20-A2 Analytical Performance

Withdrawn and replaced

Characteristics and Clinical Utility of

with newer version

Immunological Assays for Human

Immunoglobulin E (IgE) Antibodies and

Defined Allergen Specificities

7-97

7-207

CLSI GP16-A3 Urinalysis

Withdrawn and replaced with newer version

7-187

7-208

CLSI M44-S2 Zone Diameter Interpretive

Withdrawn and replaced

Standards, Corresponding Minimal Inhibitory with newer version

Concentration (MIC) Interpretive

Breakpoints, and Quality Control Limits for

Antifungal Disk Diffusion Susceptibility

Testing of Yeasts

7-37

................... NCCLS I/LA06-A Detection and Quantitation of Withdrawn

Rubella IgG Antibody: Evaluation and

Performance Criteria for Multiple Component

Test Products, Specimen Handling, and Use of Test Products in the Clinical Laboratory

F. Materials

8-104

8-189

ASTM F 1108--04 (Reapproved 2009) Standard

Withdrawn and replaced

Specification for Titanium-6Aluminum-

with newer version 4Vanadium Alloy Castings for Surgical

Implants (UNS R56406)

8-145

8-190

ASTM F 90-09 Standard Specification for

Withdrawn and replaced

Wrought Cobalt-20Chromium-15Tungsten-

with newer version 10Nickel Alloy for Surgical Implant

Applications (UNS R30605)

G. Physical Medicine

16-19

16-162

ISO 7176-4:2008 Wheelchairs--Part 4: Energy Withdrawn and replaced

Consumption of Electric Wheelchairs and

with newer version

Scooters for Determination of Theoretical

Distance Range

16-20

16-163

ISO 7176-5:2008 Wheelchairs--Part 5:

Withdrawn and replaced

Determination of Dimensions, Mass and

with newer version

Manoeuvring Space

16-23

16-164

ISO 7176-10:2008 Wheelchairs--Part 10:

Withdrawn and replaced

Determination of Obstacle-Climbing Ability with newer version of Electrically Powered Wheelchairs

16-26

16-165

ISO 7176-14:2008 Wheelchairs--Part 14 Power Withdrawn and replaced and Control Systems for Electrically

with newer version

Powered Wheelchairs and Scooters--

Requirements and Test Methods

H. Sterility

14-117

................... ANSI/AAMI ST35:2003 Handling and Biological Withdrawn

Decontamination of Reusable Medical Devices in Health Care Facilities and in

Nonclinical Settings

14-263

14-280

ANSI/AAMI ST79:2006 and A1:2008, A2:2009

Withdrawn and replaced

(Consolidated Text) Comprehensive Guide to with newer version

Steam Sterilization and Sterility Assurance in Health Care Facilities

14-256

14-286

ASTM F2095-07e1 Standard Test Methods for

Withdrawn and replaced

Pressure Decay Leak Test for Flexible

with newer version

Packages With and Without Restraining

Plates

14-255

14-281

ASTM F17-08 Standard Terminology Relating to Withdrawn and replaced

Flexible Barrier Packaging\1\

with newer version

14-245

14-282

ASTM F2338-09 Standard Test Method for

Withdrawn and replaced

Nondestructive Detection of Leaks in

with newer version

Packages by Vacuum Decay Method\1\

14-237

14-283

ASTM F 88/F 88M--09 Standard Test Method for Withdrawn and replaced

Seal Strength of Flexible Barrier

with newer version

Materials\1\

14-199

14-284

ASTM D4169-08 Standard Practice for

Withdrawn and replaced

Performance Testing of Shipping Containers with newer version and Systems\1\

14-228

................... ANSI/AAMI/ISO 11135-1:2007 Sterilization of Guidance

Health Care Products - Ethylene oxide -

Part 1: Requirements for Development,

Validation, and Routine Control of a

Sterilization Process for Medical Devices

Page 24717

14-70

14-285

ANSI/AAMI/ISO 14161:2009 Sterilization of

Withdrawn and replaced

Health Care Products - Biological

with newer version

Indicators - Guidance for the Selection,

Use and Interpretation of Results

I. Tissue Engineering

15-6

15-16

ASTM F2450-09 Standard Guide for Assessing

Withdrawn and replaced

Microstructure of Polymeric Scaffolds for

with newer version

Use in Tissue Engineered Medical

Products\1\

15-9

15-17

ASTM F2311-08 Standard Guide for

Withdrawn and replaced

Classification of Therapeutic Skin

with newer version

Substitutes\1\

15-13

15-18

ASTM F2212-09 Standard Guide for

Withdrawn and replaced

Characterization of Type I Collagen as

with newer version

Starting Material for Surgical Implants and

Substrates for Tissue Engineered Medical

Products (TEMPs)\1\

III. Listing of New Entries

In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 023.

Table 3.--New Entries to the List of Recognized Standards

Reference No. &

Recognition No.

Title of Standard

Date

A. Cardiology

3-77

Active Implantable Medical Devices-- ANSI/AAMI

Electromagnetic Compatibility--EMC

PC69:2007

Test Protocols for Implantable

Cardiac Pacemakers and Implantable

Cardioverter Defibrillators

B. In Vitro Diagnostics

7-209

Performance Metrics for Continuous

POCT 05-A

Interstitial Glucose Monitoring

C. Orthopedics

11-219

Standard Specification for

ASTM F 2026-08

Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

D. Physical Medicine

16-166

Wheelchairs--Requirements and Test

ISO 7176-21:2009

Methods for Electromagnetic

Compatibility of Electrically

Powered Wheelchairs and Scooters, and Battery Chargers

E. Sterility

14-286

Processing of Reusable Surgical

ANSI/AAMI

Textiles for Use in Health Care

ST65:2008

Facilities

IV. List of Recognized Standards

FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at

FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (See FOR FURTHER INFORMATION CONTACT). To be properly considered such recommendations should contain, at a minimum, the following information: (1) title of the standard; (2) any reference number and date; (3) name and address of the national or international standards development organization; (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply; and (5) a brief identification of the testing or performance or other characteristics of the devices that would be addressed by a declaration of conformity.

VI. Electronic Access

You may obtain a copy of ``Guidance on the Recognition and Use of

Consensus Standards'' by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal

Page 24718

computer with access to the Internet. Updated on a regular basis, the

CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this notice announcing

``Modification to the List of Recognized Standards, Recognition List

Number: 023'' will be available on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/cdrh.

You may access ``Guidance on the Recognition and Use of Consensus

Standards,'' and the searchable database for ``FDA Recognized Consensus

Standards'' through the hyperlink at http://www.fda.gov/cdrh/ stdsprog.html.

This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.fda.gov/ cdrh/fedregin.html.

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see FOR

FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 023. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register.

Dated: April 30, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

FR Doc. 2010-10562 Filed 5-4-10; 8:45 am

BILLING CODE 4160-01-S

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