[Federal Register: March 18, 2009 (Volume 74, Number = 51)] [Notices] =20 [Page 11586-11593] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr18mr09-71] =20 ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0451] =20 Food and Drug Administration Modernization Act of 1997:=20 Modifications to the List of Recognized Standards, Recognition List=20 Number: 021 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a=20 publication containing modifications the agency is making to the list=20 of standards FDA recognizes for use in premarket reviews (FDA=20 recognized consensus standards). This publication, entitled=20 ``Modifications to the List of Recognized Standards, Recognition List=20 Number: 021'' (Recognition List Number: 021), will assist manufacturers=20 who elect to declare conformity with consensus standards to meet=20 certain requirements for medical devices. DATES: Submit written or electronic comments concerning this document=20 at any time. See section VII of this document for the effective date of=20 the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of=20 ``Modifications to the List of Recognized Standards, Recognition List=20 Number: 021'' to the Division of Small Manufacturers, International and=20 Consumer Assistance, Center for Devices and Radiological Health (HFZ- 220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD=20 20850. Send two self-addressed adhesive labels to assist that office in=20 processing your requests, or fax your request to 240-276-3151. Submit=20 written comments concerning this document, or recommendations for=20 additional standards for recognition, to the contact person (see FOR=20 FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail:=20 standards@cdrh.fda.gov. = This document may also be accessed on FDA's=20 Internet site at http://frwebgate.access.gpo.gov/cgi-bin= /leaving.cgi?from=3DleavingFR.html&log=3Dlinklog&to=3Dhttp://www.= accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. See = section VI of this document for electronic=20 access to the searchable database for the current list of FDA=20 recognized consensus standards, including Recognition List Number: 021=20 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices=20 and Radiological Health (HFZ-84), Food and Drug Administration, 7520=20 Standish Place, Rockville, MD 20855, 240-276-8714. [[Page 11587]] SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act=20 of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal=20 Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended=20 section 514 allows FDA to recognize consensus standards developed by=20 international and national organizations for use in satisfying portions=20 of device premarket review submissions or other requirements. In a notice published in the Federal Register of February 25, 1998=20 (63 FR 9561), FDA announced the availability of a guidance entitled=20 ``Recognition and Use of Consensus Standards.'' The notice described=20 how FDA would implement its standard recognition program and provided=20 the initial list of recognized standards. Modifications to the initial list of recognized standards, as=20 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=20 certain standards recognized by FDA. The agency maintains ``hypertext=20 markup language (HTML)'' and ``portable document format (PDF)''=20 versions of the list of ``FDA Recognized Consensus Standards.'' Both=20 versions are publicly accessible at the agency's Internet site. See=20 section VI of this document for electronic access information.=20 Interested persons should review the supplementary information sheet=20 for the standard to understand fully the extent to which FDA recognizes=20 the standard. II. Modifications to the List of Recognized Standards, Recognition List=20 Number: 021 FDA is announcing the addition, withdrawal, correction, and=20 revision of certain consensus standards the agency will recognize for=20 use in satisfying premarket reviews and other requirements for devices.=20 FDA will incorporate these modifications in the list of FDA Recognized=20 Consensus Standards in the agency's searchable database. FDA will use=20 the term ``Recognition List Number: 021'' to identify these current=20 modifications. In table 2 of this document, FDA describes the following=20 modifications: (1) The withdrawal of standards and their replacement by=20 others; (2) the correction of errors made by FDA in listing previously=20 recognized standards; and (3) the changes to the supplementary=20 information sheets of recognized standards that describe revisions to=20 the applicability of the standards. In section III of this document, FDA lists modifications the agency=20 is making that involve the initial addition of standards not previously=20 recognized by FDA. Table 2 -------------------------------------------------------------------------= --------------------------------------- Replacement Old Recognition No. Recognition No. Standard = Change -------------------------------------------------------------------------= --------------------------------------- A. Anesthesia -------------------------------------------------------------------------= --------------------------------------- 1-49 ..................... ASTM F 1981-99 Standard = Specification for Withdrawn Suction Catheters for use = in the Respiratory Tract -------------------------------------------------------------------------= --------------------------------------- 1-63 1-77 CGA V-1:2005 Standard for = Compressed Gas Withdrawn and replaced Cylinder Valve Outlet and = Inlet with newer version Connection -------------------------------------------------------------------------= --------------------------------------- 1-64 1-78 ASME PVHO-1-2007 Safety = Standard for Withdrawn and replaced Pressure Vessels for = Human Occupancy with newer version -------------------------------------------------------------------------= --------------------------------------- [[Page 11588]] 1-71 ..................... ISO 10651-5:2006 Lung = Ventilators for Withdrawn duplicate Medical Use--Particular = requirements for Basic Safety and = Essential Performance-- Part 5: Gas-powered = Emergency Resuscitators -------------------------------------------------------------------------= --------------------------------------- 1-74 ..................... ISO 5360:2006 Anaesthetic = Vaporizers-- Contact person Agent Specific Filling = Systems -------------------------------------------------------------------------= --------------------------------------- 1-76 1-79 ISO 26825:2008 (E) = Anaesthetic And Withdrawn and replaced Respiratory = Equipment--User-Applied with newer version Labels For Syringes = Containing Drugs Used During = Anaesthesia--Colours, Design and Performance -------------------------------------------------------------------------= --------------------------------------- B. Biocompatibility -------------------------------------------------------------------------= --------------------------------------- 2-71 2-133 ASTM F1408-97 (2008) = Standard Practice for Withdrawn and replaced Subcutaneous Screening = Test for Implant with newer version Materials -------------------------------------------------------------------------= --------------------------------------- 2-73 2-134 ASTM F2065-00(2006) = Standard Practice for Withdrawn and replaced Testing for Alternative = Pathway with newer version Complement Activation in = Serum by Solid Materials -------------------------------------------------------------------------= --------------------------------------- 2-87 ..................... AAMI/ANSI/ISO = 10993-10:2002 Biological Extent of Recognition, Evaluation of Medical = Devices--Part 10: Relevant Guidance, Tests for Irritation and = Delayed-Type and Contact Person Hypersensitivity -------------------------------------------------------------------------= --------------------------------------- 2-88 2-135 AAMI/ANSI/ISO = 10993-12:2007 Biological Withdrawn and replaced Evaluation of Medical = Devices--Part 12: with newer version Sample Preparation and = Reference Materials -------------------------------------------------------------------------= --------------------------------------- 2-127 ..................... ANSI/AAMI BE = 78:2002/A1:2006 Biological Withdrawn Evaluation of Medical = Devices--Part 10: Tests For Irritation and = Delayed-Type = Hypersensitivity--Amendment 1 -------------------------------------------------------------------------= --------------------------------------- C. Cardiovascular/Neurology -------------------------------------------------------------------------= --------------------------------------- 3-67 ..................... ASTM F2129-06 Standard = Test Method for Offices, Devices Conducting Cyclic = Potentiodynamic Affected, Relevant Polarization Measurements = to Determine Guidance, CFR the Corrosion = Susceptibility of Small Citation and Product Implant Devices = Codes, Contact Person -------------------------------------------------------------------------= --------------------------------------- D. General Hospital/General Plastic Surgery -------------------------------------------------------------------------= --------------------------------------- 6-29 ..................... IEC 60601-2-19 1996-10: = Amendment 1-- Relevant guidance Medical Electrical = Equipment Part 2: Particular Requirements = for Safety of Baby Incubators -------------------------------------------------------------------------= --------------------------------------- 6-32 ..................... IEC 60601-2-20 1996-10: = Amendment 1-- Relevant guidance Medical Electrical = Equipment Part 2: Particular Requirements = for the Safety Of Transport Incubators -------------------------------------------------------------------------= --------------------------------------- 6-62 ..................... ISO 8536-6:1995 Infusion = Equipment for Relevant guidance Medical Use--Part 6: = Freeze Drying Closures for Infusion = Bottles -------------------------------------------------------------------------= --------------------------------------- 6-63 ..................... ISO 8536-7-1999: Infusion = Equipment for Relevant guidance Medical Use--Part 7: Caps = Made of Aluminum-Plastics = Combinations For Infusion Bottles -------------------------------------------------------------------------= --------------------------------------- 6-64 ..................... ISO 8536-3-1999, Infusion = Equipment for Relevant guidance Medical Use--Part 3: = Aluminum Caps for Infusion Bottles -------------------------------------------------------------------------= --------------------------------------- 6-119 ..................... ANSI/AAMI = BF7:1989/(R)2002/(R)2007 Blood Reaffirmation 2007, Transfusion Micro-Filters = Title, SDO, Date of = standard, Relevant = guidance -------------------------------------------------------------------------= --------------------------------------- 6-122 ..................... ISO 8536-5-2004:, Infusion = Equipment for Relevant guidance Medical Use--Part 5: = Burette Infusion Sets for Single Use, = Gravity Feed -------------------------------------------------------------------------= --------------------------------------- 6-127 ..................... ISO 1135-4-2004: = Transfusion Equipment for Relevant guidance Medical Use--Part 4: = Transfusion Sets for Single Use -------------------------------------------------------------------------= --------------------------------------- 6-142 ..................... ANSI/AAMI II36:2004 = Medical Electrical Title, Relevant Equipment--Part 2: = Particular guidance Requirements for Safety = of Baby Incubators -------------------------------------------------------------------------= --------------------------------------- 6-143 ..................... ANSI/AAMI II51:2004, = Medical Electrical Title, Relevant Equipment--Part 2: = Particular guidance Requirements for Safety = of Transport Incubators -------------------------------------------------------------------------= --------------------------------------- [[Page 11589]] 6-172 ..................... ISO 8536-1:2006 Infusion = Equipment for Relevant guidance Medical Use--Part 1: = Infusion Glass Bottles -------------------------------------------------------------------------= --------------------------------------- 6-173 ..................... ISO 8536-2:2001 = Corrigendum 1:2003, Relevant guidance Infusion Equipment for = Medical Use--Part 2: Closures for Infusion = Bottles -------------------------------------------------------------------------= --------------------------------------- 6-182 ..................... IEC 60601-2-38 = 1996/Amendment 1:1999, Relevant guidance Medical Electrical = Equipment--Part 2-38: Particular Requirements = for the Safety of Electrically Operated = Hospital Beds -------------------------------------------------------------------------= --------------------------------------- 6-201 ..................... ISO 8536-4:2007 Infusion = Equipment for Relevant guidance Medical Use--Part 4: = Infusion Sets for Single Use, Gravity Feed -------------------------------------------------------------------------= --------------------------------------- 6-215 ..................... ASTM F2132-01(2008)E1 = Standard Title Specification for = Puncture Resistance of Materials Used in = Containers for Discarded Medical Needles = and Other Sharps -------------------------------------------------------------------------= --------------------------------------- E. IVD -------------------------------------------------------------------------= --------------------------------------- 7-138 7-169 CLSI M27-A3 Reference = Method for Broth Withdrawn and replaced Dilution Antifungal = Susceptibility with newer version Testing of Yeasts -------------------------------------------------------------------------= --------------------------------------- 7-54 ..................... CLSI D12-A2, = Immunoprecipitin Analyses: Title Procedures for Evaluating = the Performance of Materials--Second = Edition; Approved Guideline -------------------------------------------------------------------------= --------------------------------------- 7-71 ..................... CLSI H15-A3, Reference and = Selected Contact person Procedures for the = Quantitative Determination of = Hemoglobin in Blood; Approved Standard--Third = Edition -------------------------------------------------------------------------= --------------------------------------- 7-145 ..................... CLSI H42-A2, Enumeration = of Contact person Immunologically Defined = Cell Populations by Flow Cytometry. -------------------------------------------------------------------------= --------------------------------------- 7-73 7-170 CLSI ILA21-A2 Clinical = Evaluation of Withdrawn and replaced Immunoassays = with newer version -------------------------------------------------------------------------= --------------------------------------- 7-130 ..................... CLSI H20-A2, Reference = Leucocyte Contact person Differential Count = (Proportional) and Evaluation of = Instrumental Methods; Approved Standard--Second = Edition -------------------------------------------------------------------------= --------------------------------------- 7-164 ..................... CLSI GP 28-A Microwave = Device Use in the Contact person Histology Laboratory; = Approved Guideline -------------------------------------------------------------------------= --------------------------------------- 7-168 7-171 CLSI M38-A2 Reference = Method for Broth Withdrawn and replaced Dilution Antifungal = Susceptibility with newer version Testing of Filamentous = Fungi -------------------------------------------------------------------------= --------------------------------------- F. Neurology -------------------------------------------------------------------------= --------------------------------------- 3-3 17-1 AAMI NS28:1988/(R) 2006 = Intracranial Transferred, Date of Pressure Monitoring = Devices standard, Extent of = recognition, Relevant = guidance -------------------------------------------------------------------------= --------------------------------------- 3-32 17-2 ASTM F1542-94(2000) = Standard Specification Transferred, Offices, for the Requirements and = Disclosure of Type of standard, Self-Closing Aneurysm = Clips Extent of = recognition, Relevant = guidance, Contact = person -------------------------------------------------------------------------= --------------------------------------- 3-33 17-3 ISO 7197:2006 = Neurosurgical implants-- Transferred--Withdrawn Sterile, Single-use = hydrocephalus Shunts and replaced with and Components = newer version -------------------------------------------------------------------------= --------------------------------------- 3-39 17-4 ASTM F647-94(2006) = Standard Practice for Transferred--Withdrawn Evaluating and Specifying = Implantable and replaced with Shunt Assemblies for = Neurosurgical newer version Application -------------------------------------------------------------------------= --------------------------------------- 3-60 17-5 IEC 60601-2-10 = 1987/Amendment 1 2001 Transferred, Title Medical Electrical = Equipment--Part 2-10: change, Date of Particular Requirements = for the Safety of standard, Relevant Nerve and Muscle = Stimulators guidance, Contact = person -------------------------------------------------------------------------= --------------------------------------- 3-67 17-6 ASTM F2129-06 Standard = Test Method for Offices, Devices Conducting Cyclic = Potentiodynamic affected, Type of Polarization Measurements = to Determine Standard, Product the Corrosion = Susceptibility of Small code, Relevant Implant Devices = guidance, Contact = person -------------------------------------------------------------------------= --------------------------------------- G. OB-GYN/Gastroenterology -------------------------------------------------------------------------= --------------------------------------- [[Page 11590]] 9-30 9-55 ANSI/ AAMI RD62:2006 Water = Treatment Withdrawn and replaced Equipment for = Hemodialysis Applications with newer version -------------------------------------------------------------------------= --------------------------------------- 9-32 9-56 ASTM D3492-08 Standard = Specification for Withdrawn and replaced Rubber Contraceptives = (Male Condoms) with newer version -------------------------------------------------------------------------= --------------------------------------- 9-34 ..................... ISO = 4074:2002/Cor.1:2003(E): Natural Latex Extent of recognition, Rubber = Condoms--Requirements and Test Product codes, Methods, Technical = Corrigendum 1 Relevant guidance -------------------------------------------------------------------------= --------------------------------------- H. Radiology -------------------------------------------------------------------------= --------------------------------------- 12-48 ..................... AIUM AOL, Acoustic Output = Labeling Relevant guidance Standard for Diagnostic = Ultrasound Equipment: A Standard for = How Manufacturers Should = Specify Acoustic Output Data -------------------------------------------------------------------------= --------------------------------------- 12-55 12-186 IEC 60601-2-29 (2008) = Medical Electrical Withdrawn and replaced Equipment--Part 2-29: = Particular with newer version Requirements for the = Basic Safety and Essential Performance of = Radiotherapy Simulators--Third Edition -------------------------------------------------------------------------= --------------------------------------- 12-66 ..................... AIUM MUS, Medical = Ultrasound Safety Relevant guidance -------------------------------------------------------------------------= --------------------------------------- 12-96 12-187 NEMA MS 3-2008 = Determination of Image Withdrawn and replaced Uniformity in Diagnostic = Magnetic with newer version Resonance Images -------------------------------------------------------------------------= --------------------------------------- 12-97 12-188 NEMA MS 1-2008 = Determination of Signal-to- Withdrawn and replaced Noise Ratio (SNR) in = Diagnostic Magnetic with newer version Resonance Imaging -------------------------------------------------------------------------= --------------------------------------- 12-100 ..................... NEMA UD 3-2004, Standard = for Real Time Relevant guidance Display of Thermal and = Mechanical Acoustic Output Indices = on Diagnostic Ultrasound Equipment -------------------------------------------------------------------------= --------------------------------------- 12-105 ..................... NEMA UD 2-2004, Acoustic = Output Title, Relevant Measurement Standard for = Diagnostic guidance Ultrasound Equipment = Version 3 -------------------------------------------------------------------------= --------------------------------------- 12-139 ..................... AIUM AOMS-2005, Acoustic = Output Relevant guidance Measurement Standard for = Diagnostic Ultrasound Equipment -------------------------------------------------------------------------= --------------------------------------- 12-140 ..................... AIUM RTD1-2005, Standard = for Real-Time Relevant guidance Display of Thermal and = Mechanical Acoustic Output Indices = on Diagnostic Ultrasound Equipment = Revision 1 -------------------------------------------------------------------------= --------------------------------------- 12-161 12-189 IEC 60601-2-33 (2008) = Medical Electrical Withdrawn and replaced Equipment--Part 2-33: = Particular with a newer version Requirements for the = Safety of Magnetic Resonance Equipment for = Medical Diagnosis Consolidated Edition 2.2 -------------------------------------------------------------------------= --------------------------------------- 12-182 ..................... IEC 60601-2-37:2007, = Medical Electrical Relevant guidance Equipment--Part 2-37: = Particular Requirements for the = Basic Safety and Essential Performance of = Ultrasonic Medical Diagnostic and = Monitoring Equipment -------------------------------------------------------------------------= --------------------------------------- 12-184 12-190 IEC 61217 (2008) = Radiotherapy Equipment-- Withdrawn and replaced Coordinates, Movements, = and Scales with newer version Consolidated Edition 1.2 -------------------------------------------------------------------------= --------------------------------------- I. Sterility -------------------------------------------------------------------------= --------------------------------------- 14-120 14-257 ASTM D3078--02(2008) = Standard Test Method Withdrawn and replaced for Determination of = Leaks in Flexible with newer version Packaging by Bubble = Emission -------------------------------------------------------------------------= --------------------------------------- 14-148 14-258 ASTM F2250--03(2008) = Standard Practice for Withdrawn and replaced Evaluation of Chemical = Resistance of with newer version Printed Inks and Coatings = on Flexible Packaging Materials -------------------------------------------------------------------------= --------------------------------------- 14-149 14-259 ASTM F2251--03(2008) = Standard Test Method Withdrawn and replaced for Thickness Measurement = of Flexible with newer version Packaging Material -------------------------------------------------------------------------= --------------------------------------- 14-150 14-260 ASTM F2252--03(2008) = Standard Practice for Withdrawn and replaced Evaluating Ink or Coating = Adhesion to with newer version Flexible Packaging = Materials Using Tape -------------------------------------------------------------------------= --------------------------------------- J. Tissue Engineering -------------------------------------------------------------------------= --------------------------------------- 15-11 15-13 ASTM F2212-02(2008)e1, = Standard Guide for Withdrawn and replaced Characterization of Type = I Collagen as a with newer version Starting Material for = Surgical Implants and Substrates for Tissue = Engineered Medical Products -------------------------------------------------------------------------= --------------------------------------- [[Page 11591]] III. Listing of New Entries In table 3 of this document, FDA provides the listing of new=20 entries and consensus standards added as modifications to the list of=20 recognized standards under Recognition List Number: 021. Table 3 -------------------------------------------------------------------------= --------------------------------------- Recognition No. Title of Standard = Reference No. & Date -------------------------------------------------------------------------= --------------------------------------- A. Dental/ENT -------------------------------------------------------------------------= --------------------------------------- 4-160 Maximum Permissible Ambient Noise Levels for = Audiometric ANSI ASA S3.1-1999 (R Test Rooms = 2003) -------------------------------------------------------------------------= --------------------------------------- 4-161 Method for Measuring the Intelligibility of = Speech Over ANSI ASA S3.2-1989 (R Communication Systems = 1999) -------------------------------------------------------------------------= --------------------------------------- 4-162 Procedure for the Computation of Loudness of = Steady Sounds ANSI ASA S3.4-2007 -------------------------------------------------------------------------= --------------------------------------- 4-163 Methods for Calculation of the Speech = Intelligibility Index ANSI ASA S3.5-1997 (R = 2007) -------------------------------------------------------------------------= --------------------------------------- 4-164 Method for Coupler Calibration of Earphones = ANSI ASA S3.7-1995 (R = 2003) -------------------------------------------------------------------------= --------------------------------------- 4-165 Mechanical Coupler for Measurement of Bone = Vibrators ANSI ASA S3.13-1987 (R = 2007) -------------------------------------------------------------------------= --------------------------------------- 4-166 Bioacoustical Terminology = ANSI ASA S3.20-1995 (R = 2003) -------------------------------------------------------------------------= --------------------------------------- 4-167 Methods for Manual Pure-Tone Threshold = Audiometry ANSI ASA S3.21-2004 -------------------------------------------------------------------------= --------------------------------------- 4-168 Occluded Ear Simulator = ANSI ASA S3.25-1989 (R = 2003) -------------------------------------------------------------------------= --------------------------------------- 4-169 Method of Measurement of Performance = Characteristics of ANSI ASA S3.35-2004 Hearing Aids under Simulated Real-Ear Working = Conditions -------------------------------------------------------------------------= --------------------------------------- 4-170 Specification for a Manikin for Simulated in = situ Airborne ANSI ASA S3.36-1985 (R Acoustic Measurements = 2006) -------------------------------------------------------------------------= --------------------------------------- 4-171 Preferred Earhook Nozzle Thread for = Postauricular Hearing ANSI ASA S3.37-1987 (R Aids = 2007) -------------------------------------------------------------------------= --------------------------------------- 4-172 Testing Hearing Aids with a Broad-Band Noise = Signal ANSI ASA S3.42-1992 (R = 2007) -------------------------------------------------------------------------= --------------------------------------- 4-173 Determination of Occupational Noise Exposure and = Estimation ANSI ASA S3.44-1996 (R of Noise-Induced Hearing Impairment = 2006) -------------------------------------------------------------------------= --------------------------------------- 4-174 Procedures for Testing Basic Vestibular Function = ANSI ASA S3.45-1999 -------------------------------------------------------------------------= --------------------------------------- 4-175 Methods of Measurement of Real-Ear Performance = ANSI ASA S3.46-1997 (R Characteristics of Hearing Aids = 2002) -------------------------------------------------------------------------= --------------------------------------- 4-176 Criteria for Evaluating Room Noise = ANSI ASA S12.2-1995 (R = 1999) -------------------------------------------------------------------------= --------------------------------------- 4-177 Rating Noise with Respect to Speech Interference = ANSI ASA S12.65-2006 -------------------------------------------------------------------------= --------------------------------------- B. General -------------------------------------------------------------------------= --------------------------------------- 5-45 Standard Practice for Performance Testing of = Packages for ASTM D7386-08 Single Delivery Systems -------------------------------------------------------------------------= --------------------------------------- C. IVD -------------------------------------------------------------------------= --------------------------------------- 7-172 Defining, Establishing, and Verifying Reference = Intervals in C28-P3 the Clinical Laboratory -------------------------------------------------------------------------= --------------------------------------- 7-173 Harmonization of Glycohemoglobin Measurements = C44-A -------------------------------------------------------------------------= --------------------------------------- 7-174 Estimation of Total Analytical Error for = Clinical Laboratory EP21-A -------------------------------------------------------------------------= --------------------------------------- 7-175 Apolipoprotein Immunoassays: Development and = Recommended ILA15-A Performance Characteristics -------------------------------------------------------------------------= --------------------------------------- 7-176 Immunoassay Interference by Endogenous = Antibodies ILA30-A -------------------------------------------------------------------------= --------------------------------------- [[Page 11592]] 7-177 Performance Standards for Antimicrobial = Susceptibility M100-S18 Testing -------------------------------------------------------------------------= --------------------------------------- 7-178 Quality Control for Commercially Prepared = Microbiological M22-A3 Culture Media -------------------------------------------------------------------------= --------------------------------------- 7-179 Reference Method for Broth Dilution Antifungal = M27-S3 Susceptibility Testing of Yeasts -------------------------------------------------------------------------= --------------------------------------- 7-180 Western Blot Assay for Antibodies to Borrelia = burgdorferi M34-A -------------------------------------------------------------------------= --------------------------------------- 7-181 Abbreviated Identification of Bacteria and = Yeasts M35-A -------------------------------------------------------------------------= --------------------------------------- 7-182 Clinical Use and Interpretation of Serologic = Tests for M36-A Toxoplasma gondii -------------------------------------------------------------------------= --------------------------------------- 7-183 Reference Method for Broth Dilution Antifungal = M38-A2 Susceptibility Testing of Filamentous Fungi -------------------------------------------------------------------------= --------------------------------------- 7-184 Quality Control of Microbiological Transport = Systems M40-A -------------------------------------------------------------------------= --------------------------------------- 7-185 Viral Culture = M41-A -------------------------------------------------------------------------= --------------------------------------- 7-186 Methods for Antifungal Disk Diffusion = Susceptibility Testing M44-A -------------------------------------------------------------------------= --------------------------------------- 7-187 Zone Diameter Interpretive Standards, = Corresponding Minimal M44-S2 Inhibitory Concentration (MIC) Interpretive = Breakpoints, and Quality Control Limits for Antifungal Disk = Diffusion Susceptibility Testing of Yeast -------------------------------------------------------------------------= --------------------------------------- 7-188 Methods for Antimicrobial Dilution and Disk = Susceptibility M45-A Testing of Infrequently Isolated or Fastidious = Bacteria -------------------------------------------------------------------------= --------------------------------------- 7-189 Principles and Procedures for Blood Cultures = M47-A -------------------------------------------------------------------------= --------------------------------------- 7-190 Quality Control for Commercial Microbial = Identification M50-A Systems -------------------------------------------------------------------------= --------------------------------------- 7-191 Collection, Transport, Preparation, and Storage = of Specimens MM13-A -------------------------------------------------------------------------= --------------------------------------- 7-192 Interpretive Criteria for Identification of = Bacteria and MM18-A Fungi by DNA Target Sequencing -------------------------------------------------------------------------= --------------------------------------- 7-193 Evaluation of the Linearity of Quantitative = Measurement EP06-A -------------------------------------------------------------------------= --------------------------------------- 7-194 Protocols for Determination of Limits of = Detection and EP17-A Limits of Quantitation -------------------------------------------------------------------------= --------------------------------------- D. Neurology -------------------------------------------------------------------------= --------------------------------------- 17-7 Neurosurgical implants--Sterile, Single-use = Hydrocephalus ISO 7197:2006/Technical Shunts and Components = Corrigendum1:2007 -------------------------------------------------------------------------= --------------------------------------- E. OB-GYN/Gastroenterology -------------------------------------------------------------------------= --------------------------------------- 9-57 Natural Latex Rubber Condoms--Requirements and = Test Methods, ISO 4074:2002/ Technical Corrigendum 2 = Cor.2:2008(E) -------------------------------------------------------------------------= --------------------------------------- F. Ophthalmic -------------------------------------------------------------------------= --------------------------------------- 10-58 Laser Systems for Corneal Reshaping = ANSI Z80.11-2007 -------------------------------------------------------------------------= --------------------------------------- G. Radiology -------------------------------------------------------------------------= --------------------------------------- 12-191 Ultrasonics--Field Characterization--Test = Methods for the IEC 62359:2005 Determination of Thermal and Mechanical Indices = Related to Medical Diagnostic Ultrasonic Fields -------------------------------------------------------------------------= --------------------------------------- H. Software/Informatic -------------------------------------------------------------------------= --------------------------------------- 13-25 Managing and Validating Laboratory Information = Systems; CLSI AUTO8-A Approved Guideline -------------------------------------------------------------------------= --------------------------------------- 13-26 Autoverification of Clinical Laboratory Test = Results; CLSI AUTO10-A Approved Guideline -------------------------------------------------------------------------= --------------------------------------- 13-27 IT Security of In Vitro Diagnostic Instruments = and Software CLSI AUTO11-A Systems; Approved Standard -------------------------------------------------------------------------= --------------------------------------- 13-28 Remote Access to Clinical Laboratory Diagnostic = Devices via CLSI AUTO9-A the Internet; Approved Standard -------------------------------------------------------------------------= --------------------------------------- I. Sterility -------------------------------------------------------------------------= --------------------------------------- 14-261 Sterilization of Health Care Products--Moist = Heat--Part 1: ANSI/AAMI/ISO 17665-1:2006 Requirements for the Development, Validation, = and Routine Control of a Sterilization Process for Medical = Devices -------------------------------------------------------------------------= --------------------------------------- [[Page 11593]] IV. List of Recognized Standards FDA maintains the agency's current list of FDA recognized consensus=20 standards in a searchable database that may be accessed directly at=20 FDA's Internet site at http://frwebgate.access.gpo.gov/cgi-= bin/leaving.cgi?from=3DleavingFR.html&log=3Dlinklog&to=3Dhttp://w= ww.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. = FDA will incorporate the modifications=20 and minor revisions described in this document into the database and,=20 upon publication in the Federal Register, this recognition of consensus=20 standards will be effective. FDA will announce additional modifications=20 and minor revisions to the list of recognized consensus standards, as=20 needed, in the Federal Register once a year, or more often, if=20 necessary. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for=20 recognition under the new provision of section 514 of the act by=20 submitting such recommendations, with reasons for the recommendation,=20 to the contact person (See FOR FURTHER INFORMATION CONTACT). To be=20 properly considered such recommendations should contain, at a minimum,=20 the following information: (1) Title of the standard; (2) any reference=20 number and date; (3) name and address of the national or international=20 standards development organization; (4) a proposed list of devices for=20 which a declaration of conformity to this standard should routinely=20 apply; and (5) a brief identification of the testing or performance or=20 other characteristics of the device(s) that would be addressed by a=20 declaration of conformity. VI. Electronic Access You may obtain a copy of ``Guidance on the Recognition and Use of=20 Consensus Standards'' by using the Internet. CDRH maintains a site on=20 the Internet for easy access to information including text, graphics,=20 and files that you may download to a personal computer with access to=20 the Internet. Updated on a regular basis, the CDRH home page includes=20 the guidance as well as the current list of recognized standards and=20 other standards related documents. After publication in the Federal=20 Register, this document announcing ``Modification to the List of=20 Recognized Standards, Recognition List Number: 021'' will be available=20 on the CDRH home page. You may access the CDRH home page at http://frweb= gate.access.gpo.gov/cgi-bin/leaving.cgi?from=3DleavingFR.html&log=3Dl= inklog&to=3Dhttp://www.fda.gov/cdrh. You may access ``Guidance on the Recognition and Use of Consensus=20 Standards,'' and the searchable database for ``FDA Recognized Consensus=20 Standards'' through the hyperlink at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=3DleavingFR.ht= ml&log=3Dlinklog&to=3Dhttp://www.fda.gov/cdrh/stdsprog.html. This Federal Register document on modifications in FDA's=20 recognition of consensus standards is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=3DleavingFR.ht= ml&log=3Dlinklog&to=3Dhttp://www.fda.gov/cdrh/fedregin.html. VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR=20 FURTHER INFORMATION CONTACT) written or electronic comments regarding=20 this document. Two copies of any mailed comments are to be submitted,=20 except that individuals may submit one paper copy. Comments are to be=20 identified with the docket number found in brackets in the heading of=20 this document. FDA will consider any comments received in determining=20 whether to amend the current listing of modifications to the list of=20 recognized standards, Recognition List Number: 021. These modifications=20 to the list or recognized standards are effective upon publication of=20 this document in the Federal Register. Dated: March 10, 2009. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E9-5858 Filed 3-17-09; 8:45 am] BILLING CODE 4160-01-S