Skip to Content

Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 021

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 021” (Recognition List Number: 021), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

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

ADDRESSES:

Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 021” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 240-276-3151. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.gov. This document may also be accessed on FDA's Internet site at http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfTopic/​cdrhnew.cfm. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 021 modifications and other standards related information.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, 240-276-8714.Start Printed Page 11587

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards.

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

Table 1—Federal Register Citation

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

These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language (HTML)” and “portable document format (PDF)” versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List Number: 021

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency's searchable database. FDA will use the term “Recognition List Number: 021” to identify these current modifications.

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

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

Table 2

Old Recognition No.Replacement Recognition No.StandardChange
A. Anesthesia
1-49ASTM F 1981-99 Standard Specification for Suction Catheters for use in the Respiratory TractWithdrawn
1-631-77CGA V-1:2005 Standard for Compressed Gas Cylinder Valve Outlet and Inlet ConnectionWithdrawn and replaced with newer version
1-641-78ASME PVHO-1-2007 Safety Standard for Pressure Vessels for Human OccupancyWithdrawn and replaced with newer version
Start Printed Page 11588
1-71ISO 10651-5:2006 Lung Ventilators for Medical Use—Particular requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency ResuscitatorsWithdrawn duplicate
1-74ISO 5360:2006 Anaesthetic Vaporizers—Agent Specific Filling SystemsContact person
1-761-79ISO 26825:2008 (E) Anaesthetic And Respiratory Equipment—User-Applied Labels For Syringes Containing Drugs Used During Anaesthesia—Colours, Design and PerformanceWithdrawn and replaced with newer version
B. Biocompatibility
2-712-133ASTM F1408-97 (2008) Standard Practice for Subcutaneous Screening Test for Implant MaterialsWithdrawn and replaced with newer version
2-732-134ASTM F2065-00(2006) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid MaterialsWithdrawn and replaced with newer version
2-87AAMI/ANSI/ISO 10993-10:2002 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-Type HypersensitivityExtent of Recognition, Relevant Guidance, and Contact Person
2-882-135AAMI/ANSI/ISO 10993-12:2007 Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference MaterialsWithdrawn and replaced with newer version
2-127ANSI/AAMI BE 78:2002/A1:2006 Biological Evaluation of Medical Devices—Part 10: Tests For Irritation and Delayed-Type Hypersensitivity—Amendment 1Withdrawn
C. Cardiovascular/Neurology
3-67ASTM F2129-06 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesOffices, Devices Affected, Relevant Guidance, CFR Citation and Product Codes, Contact Person
D. General Hospital/General Plastic Surgery
6-29IEC 60601-2-19 1996-10: Amendment 1—Medical Electrical Equipment Part 2: Particular Requirements for Safety of Baby IncubatorsRelevant guidance
6-32IEC 60601-2-20 1996-10: Amendment 1—Medical Electrical Equipment Part 2: Particular Requirements for the Safety Of Transport IncubatorsRelevant guidance
6-62ISO 8536-6:1995 Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion BottlesRelevant guidance
6-63ISO 8536-7-1999: Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-Plastics Combinations For Infusion BottlesRelevant guidance
6-64ISO 8536-3-1999, Infusion Equipment for Medical Use—Part 3: Aluminum Caps for Infusion BottlesRelevant guidance
6-119ANSI/AAMI BF7:1989/(R)2002/(R)2007 Blood Transfusion Micro-FiltersReaffirmation 2007, Title, SDO, Date of standard, Relevant guidance
6-122ISO 8536-5-2004:, Infusion Equipment for Medical Use—Part 5: Burette Infusion Sets for Single Use, Gravity FeedRelevant guidance
6-127ISO 1135-4-2004: Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single UseRelevant guidance
6-142ANSI/AAMI II36:2004 Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Baby IncubatorsTitle, Relevant guidance
6-143ANSI/AAMI II51:2004, Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Transport IncubatorsTitle, Relevant guidance
Start Printed Page 11589
6-172ISO 8536-1:2006 Infusion Equipment for Medical Use—Part 1: Infusion Glass BottlesRelevant guidance
6-173ISO 8536-2:2001 Corrigendum 1:2003, Infusion Equipment for Medical Use—Part 2: Closures for Infusion BottlesRelevant guidance
6-182IEC 60601-2-38 1996/Amendment 1:1999, Medical Electrical Equipment—Part 2-38: Particular Requirements for the Safety of Electrically Operated Hospital BedsRelevant guidance
6-201ISO 8536-4:2007 Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity FeedRelevant guidance
6-215ASTM F2132-01(2008)E1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other SharpsTitle
E. IVD
7-1387-169CLSI M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of YeastsWithdrawn and replaced with newer version
7-54CLSI D12-A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved GuidelineTitle
7-71CLSI H15-A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third EditionContact person
7-145CLSI H42-A2, Enumeration of Immunologically Defined Cell Populations by Flow Cytometry.Contact person
7-737-170CLSI ILA21-A2 Clinical Evaluation of ImmunoassaysWithdrawn and replaced with newer version
7-130CLSI H20-A2, Reference Leucocyte Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second EditionContact person
7-164CLSI GP 28-A Microwave Device Use in the Histology Laboratory; Approved GuidelineContact person
7-1687-171CLSI M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous FungiWithdrawn and replaced with newer version
F. Neurology
3-317-1AAMI NS28:1988/(R) 2006 Intracranial Pressure Monitoring DevicesTransferred, Date of standard, Extent of recognition, Relevant guidance
3-3217-2ASTM F1542-94(2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm ClipsTransferred, Offices, Type of standard, Extent of recognition, Relevant guidance, Contact person
3-3317-3ISO 7197:2006 Neurosurgical implants—Sterile, Single-use hydrocephalus Shunts and ComponentsTransferred—Withdrawn and replaced with newer version
3-3917-4ASTM F647-94(2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical ApplicationTransferred—Withdrawn and replaced with newer version
3-6017-5IEC 60601-2-10 1987/Amendment 1 2001 Medical Electrical Equipment—Part 2-10: Particular Requirements for the Safety of Nerve and Muscle StimulatorsTransferred, Title change, Date of standard, Relevant guidance, Contact person
3-6717-6ASTM F2129-06 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesOffices, Devices affected, Type of Standard, Product code, Relevant guidance, Contact person
G. OB-GYN/Gastroenterology
Start Printed Page 11590
9-309-55ANSI/ AAMI RD62:2006 Water Treatment Equipment for Hemodialysis ApplicationsWithdrawn and replaced with newer version
9-329-56ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)Withdrawn and replaced with newer version
9-34ISO 4074:2002/Cor.1:2003(E): Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1Extent of recognition, Product codes, Relevant guidance
H. Radiology
12-48AIUM AOL, Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment: A Standard for How Manufacturers Should Specify Acoustic Output DataRelevant guidance
12-5512-186IEC 60601-2-29 (2008) Medical Electrical Equipment—Part 2-29: Particular Requirements for the Basic Safety and Essential Performance of Radiotherapy Simulators—Third EditionWithdrawn and replaced with newer version
12-66AIUM MUS, Medical Ultrasound SafetyRelevant guidance
12-9612-187NEMA MS 3-2008 Determination of Image Uniformity in Diagnostic Magnetic Resonance ImagesWithdrawn and replaced with newer version
12-9712-188NEMA MS 1-2008 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance ImagingWithdrawn and replaced with newer version
12-100NEMA UD 3-2004, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound EquipmentRelevant guidance
12-105NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3Title, Relevant guidance
12-139AIUM AOMS-2005, Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentRelevant guidance
12-140AIUM RTD1-2005, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1Relevant guidance
12-16112-189IEC 60601-2-33 (2008) Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis Consolidated Edition 2.2Withdrawn and replaced with a newer version
12-182IEC 60601-2-37:2007, Medical Electrical Equipment—Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring EquipmentRelevant guidance
12-18412-190IEC 61217 (2008) Radiotherapy Equipment—Coordinates, Movements, and Scales Consolidated Edition 1.2Withdrawn and replaced with newer version
I. Sterility
14-12014-257ASTM D3078—02(2008) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble EmissionWithdrawn and replaced with newer version
14-14814-258ASTM F2250—03(2008) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging MaterialsWithdrawn and replaced with newer version
14-14914-259ASTM F2251—03(2008) Standard Test Method for Thickness Measurement of Flexible Packaging MaterialWithdrawn and replaced with newer version
14-15014-260ASTM F2252—03(2008) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using TapeWithdrawn and replaced with newer version
J. Tissue Engineering
15-1115-13ASTM F2212-02(2008)e1, Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical ProductsWithdrawn and replaced with newer version
Start Printed Page 11591

III. Listing of New Entries

In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 021.

Table 3

Recognition No.Title of StandardReference No. & Date
A. Dental/ENT
4-160Maximum Permissible Ambient Noise Levels for Audiometric Test RoomsANSI ASA S3.1-1999 (R 2003)
4-161Method for Measuring the Intelligibility of Speech Over Communication SystemsANSI ASA S3.2-1989 (R 1999)
4-162Procedure for the Computation of Loudness of Steady SoundsANSI ASA S3.4-2007
4-163Methods for Calculation of the Speech Intelligibility IndexANSI ASA S3.5-1997 (R 2007)
4-164Method for Coupler Calibration of EarphonesANSI ASA S3.7-1995 (R 2003)
4-165Mechanical Coupler for Measurement of Bone VibratorsANSI ASA S3.13-1987 (R 2007)
4-166Bioacoustical TerminologyANSI ASA S3.20-1995 (R 2003)
4-167Methods for Manual Pure-Tone Threshold AudiometryANSI ASA S3.21-2004
4-168Occluded Ear SimulatorANSI ASA S3.25-1989 (R 2003)
4-169Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working ConditionsANSI ASA S3.35-2004
4-170Specification for a Manikin for Simulated in situ Airborne Acoustic MeasurementsANSI ASA S3.36-1985 (R 2006)
4-171Preferred Earhook Nozzle Thread for Postauricular Hearing AidsANSI ASA S3.37-1987 (R 2007)
4-172Testing Hearing Aids with a Broad-Band Noise SignalANSI ASA S3.42-1992 (R 2007)
4-173Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing ImpairmentANSI ASA S3.44-1996 (R 2006)
4-174Procedures for Testing Basic Vestibular FunctionANSI ASA S3.45-1999
4-175Methods of Measurement of Real-Ear Performance Characteristics of Hearing AidsANSI ASA S3.46-1997 (R 2002)
4-176Criteria for Evaluating Room NoiseANSI ASA S12.2-1995 (R 1999)
4-177Rating Noise with Respect to Speech InterferenceANSI ASA S12.65-2006
B. General
5-45Standard Practice for Performance Testing of Packages for Single Delivery SystemsASTM D7386-08
C. IVD
7-172Defining, Establishing, and Verifying Reference Intervals in the Clinical LaboratoryC28-P3
7-173Harmonization of Glycohemoglobin MeasurementsC44-A
7-174Estimation of Total Analytical Error for Clinical LaboratoryEP21-A
7-175Apolipoprotein Immunoassays: Development and Recommended Performance CharacteristicsILA15-A
7-176Immunoassay Interference by Endogenous AntibodiesILA30-A
Start Printed Page 11592
7-177Performance Standards for Antimicrobial Susceptibility TestingM100-S18
7-178Quality Control for Commercially Prepared Microbiological Culture MediaM22-A3
7-179Reference Method for Broth Dilution Antifungal Susceptibility Testing of YeastsM27-S3
7-180Western Blot Assay for Antibodies to Borrelia burgdorferiM34-A
7-181Abbreviated Identification of Bacteria and YeastsM35-A
7-182Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondiiM36-A
7-183Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous FungiM38-A2
7-184Quality Control of Microbiological Transport SystemsM40-A
7-185Viral CultureM41-A
7-186Methods for Antifungal Disk Diffusion Susceptibility TestingM44-A
7-187Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of YeastM44-S2
7-188Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious BacteriaM45-A
7-189Principles and Procedures for Blood CulturesM47-A
7-190Quality Control for Commercial Microbial Identification SystemsM50-A
7-191Collection, Transport, Preparation, and Storage of SpecimensMM13-A
7-192Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target SequencingMM18-A
7-193Evaluation of the Linearity of Quantitative MeasurementEP06-A
7-194Protocols for Determination of Limits of Detection and Limits of QuantitationEP17-A
D. Neurology
17-7Neurosurgical implants—Sterile, Single-use Hydrocephalus Shunts and ComponentsISO 7197:2006/Technical Corrigendum1:2007
E. OB-GYN/Gastroenterology
9-57Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 2ISO 4074:2002/Cor.2:2008(E)
F. Ophthalmic
10-58Laser Systems for Corneal ReshapingANSI Z80.11-2007
G. Radiology
12-191Ultrasonics—Field Characterization—Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic FieldsIEC 62359:2005
H. Software/Informatic
13-25Managing and Validating Laboratory Information Systems; Approved GuidelineCLSI AUTO8-A
13-26Autoverification of Clinical Laboratory Test Results; Approved GuidelineCLSI AUTO10-A
13-27IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved StandardCLSI AUTO11-A
13-28Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved StandardCLSI AUTO9-A
I. Sterility
14-261Sterilization of Health Care Products—Moist Heat—Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical DevicesANSI/AAMI/ISO 17665-1:2006
Start Printed Page 11593

IV. List of Recognized Standards

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

V. Recommendation of Standards for Recognition by FDA

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

VI. Electronic Access

You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this document announcing “Modification to the List of Recognized Standards, Recognition List Number: 021” will be available on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/​cdrh.

You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” through the hyperlink at http://www.fda.gov/​cdrh/​stdsprog.html.

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

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 021. These modifications to the list or recognized standards are effective upon publication of this document in the Federal Register.

Start Signature

Dated: March 10, 2009.

Daniel G. Schultz,

Director, Center for Devices and Radiological Health.

End Signature End Supplemental Information

[FR Doc. E9-5858 Filed 3-17-09; 8:45 am]

BILLING CODE 4160-01-S