Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 026, 13631-13638 [2011-5815]

Download as PDF 13631 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Total number of waiver requests annually Annual frequency per response Number of sponsors/ applicants Total average burden hours Total hours Federal Food, Drug, and Cosmetic Act Section 736 .......... Reconsideration Requests ................................................... Appeal Requests .................................................................. 90 3 1 1.2 1 1 75 3 1 16 24 12 1,440 72 12 Total .............................................................................. ........................ ........................ ........................ ........................ 1,524 1 There are no capital operating and maintenance costs associated with this collection of information. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Dated: March 4, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–5737 Filed 3–11–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 026 mstockstill on DSKH9S0YB1PROD with NOTICES Food and Drug Administration, HHS. ACTION: Notice. 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 SUMMARY: VerDate Mar<15>2010 16:20 Mar 11, 2011 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. DATES: Submit written requests for single copies of ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 026’’ 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, Silver Spring, MD 20993. Send two selfaddressed 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 https://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. 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: 026 modifications and other standards related information. ADDRESSES: Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https://www.fda. gov.BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ guidances/default.htm, or https:// www.regulations.gov. AGENCY: consensus standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 026’’ (Recognition List Number: 026), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. Jkt 223001 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, 301–796–6574. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105–115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 as follows: TABLE 1—PREVIOUS PUBLICATIONS OF STANDARD RECOGNITION LISTS February 25, 1998 (63 FR 9561). October 16, 1998 (63 FR 55617). July 12, 1999 (64 FR 37546). November 15, 2000 (65 FR 69022). May 7, 2001 (66 FR 23032). January 14, 2002 (67 FR 1774). October 2, 2002 (67 FR 61893). April 28, 2003 (68 FR 22391). March 8, 2004 (69 FR 10712). June 18, 2004 (69 FR 34176). October 4, 2004 (69 FR 59240). May 27, 2005 (70 FR 30756). November 8, 2005 (70 FR 67713). March 31, 2006 (71 FR 16313). June 23, 2006 (71 FR 36121). November 3, 2006 (71 FR 64718). May 21, 2007 (72 FR 28500). September 12, 2007 (72 FR 52142). December 19, 2007 (72 FR 71924). September 9, 2008 (73 FR 52358). March, 18, 2009 (74 FR 11586). September 8, 2009 (74 FR 46203). May 5, 2010 (75 FR 24711). June 10, 2010 (75 FR 32943). October 4, 2010 (75 FR 61148). E:\FR\FM\14MRN1.SGM 14MRN1 13632 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 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: 026 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: 026’’ to identify these current modifications. In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, (2) the correction of errors made by FDA in listing previously recognized standards, and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS Old recognition No. Replacement recognition No. Title of standard 1 Change A. Anesthesia 1–56 .............. ........................ CGA V–7.1 1997 (R2003) (2008) Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases—First Edition. Reaffirmation. B. Biocompatibility 2–96 .............. 2–162 2–117 ............ ........................ ASTM F1903–10 Standard Practice for Testing For Biological Responses to Particles In Vitro. ANSI/AAMI/ISO 10993–3:2003/(R)2009 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. Withdrawn and replaced with newer version. Extent of recognition. C. Cardiovascular 3–54 .............. ........................ 3–58 .............. ........................ 3–66 .............. ........................ ANSI/AAMI/ISO 7198:1998/2001/(R)2010 Cardiovascular implants—Tubular vascular prostheses. ANSI/AAMI/ISO 5840:2005/(R)2010 Cardiovascular implants—Cardiac valve prostheses. ASTM F 2081–06 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents. Reaffirmation. Reaffirmation. Device affected, Processes impacted, Type of standard, CFR citation and product codes, and Contact person. D. Dental/ENT ........................ ........................ 4–112 ............ ........................ 4–124 ............ 4–191 4–127 ............ 4–192 ADA Specification No. 53 Polymer-Based Crowns and Bridge Resins .... ADA Specification No. 13 Denture Cold-Curing Repair Resins: 1981 (Reaffirmed 2006). ADA Specification No. 16 Dental Impression Paste—Zinc Oxide Eugenol Type. ANSI/ASA S3.22–2009 American National Standard Specification of Hearing Aid Characteristics. ADA Specification 58 Root Canal Files, Type H (Hedstrom) 2007 ........... 4–138 ............ 4–193 ADA Specification No. 15 Artificial Teeth for Dental Prostheses .............. 4–148 ............ 4–194 ADA Specification No. 78 Dental Obturating Cones ................................. 4–158 ............ mstockstill on DSKH9S0YB1PROD with NOTICES 4–89 .............. 4–111 ............ ........................ ISO 10139–1:2005 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use Technical Corrigendum 1:2006. Reaffirmation. Withdrawn. Withdrawn. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn and replaced with newer and replaced with newer and replaced with newer and replaced with newer duplicate. See 4–189. E. General Hospital/General Plastic Surgery 6–144 ............ 6–243 6–145 ............ 6–149 ............ ........................ ........................ VerDate Mar<15>2010 16:20 Mar 11, 2011 ASTM D5712–10 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method. ASTM D3578–05 Standard Specification for Rubber Examination Gloves ASTM D7160–05 (Reapproved 2010) Standard Practice for Determination of Expiration Dating for Medical Gloves. Jkt 223001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM Withdrawn and replaced with a newer version. Reaffirmation. Reaffirmation. 14MRN1 13633 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 6–150 ............ ........................ 6–165 ............ ........................ 6–167 ............ 6–244 6–169 ............ ........................ 6–201 ............ 6–245 6–218 ............ 6–246 ASTM D7161–05 (Reapproved 2010) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions. ASTM D6977–04 (Reapproved 2010) Standard Specification for Polychloroprene Examination Gloves for Medical Application. ASTM D6319–10 Standard Specification for Nitrile Examination Gloves for Medical Application. ASTM D3772–01 (Reapproved 2010) Standard Specification for Natural Rubber Finger Cots. ISO 8536–4 Fifth edition 2010–10–01 Infusion equipment for medical use—Part 4: Infusion sets for single use, gravity feed. USP 33–NF 28 2010 <11> Nonabsorbable Surgical Suture ..................... 6–220 ............ 6–247 USP 33–NF 28 2010 Absorbable Surgical Suture .................................... 6–221 ............ 6–248 USP 33–NF 28 2010 <881> Tensile Strength ........................................... 6–222 ............ 6–249 USP 33–NF 28 2010 <861> Suture–Diameter .......................................... 6–223 ............ 6–250 USP 33–NF 28 2010 <871> Sutures—Needle Attachment ...................... 6–224 ............ 6–251 USP 33 NF–28 2010 <11> Sterile Water for Irrigation ............................. 6–225 ............ 6–252 USP 33 NF–28 2010 <11> Heparin Lock Flush Solution ......................... Title of standard 1 Change Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer F. IVD 7–183 ............ ........................ 7–188 ............ 7–218 CLSI M38–A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi. CLSI M45–A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition. Withdrawn duplicate. See 7–171. Withdrawn and replaced with newer version. G. Materials 8–10 .............. ........................ 8–88 .............. 8–195 8–101 ............ ........................ 8–103 ............ ........................ 8–107 ............ ........................ 8–117 ............ ........................ ASTM F603–00 Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application. ASTM F2024–10 Standard Practice for X–Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings. ASTM F 2118—03 (Reapproved 2009) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials. ASTM F1801—97 (Reapproved 2009)e1 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials. ASTM F746—04 (Reapproved 2009) e1 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials. ASTM F86—04 (Reapproved 2009) Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants. Withdrawn. Withdrawn and replaced with newer version. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. H. OB–GYN/Gastroenterology ........................ 9–48 .............. ........................ 9–50 .............. mstockstill on DSKH9S0YB1PROD with NOTICES 9–47 .............. ........................ 9–51 .............. 9–65 9–52 .............. 9–66 9–55 .............. ........................ VerDate Mar<15>2010 16:20 Mar 11, 2011 AAMI RD16 Cardiovascular implants and artificial organs— Hemodialyzers, hemodiafilters. AAMI RD17 Cardiovascular implants and artificial organs— Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters. ANSI/AAMI RD52:2004/(R)2010 and ANSI/AAMI RD52:2004/A1:2007/ (R)2010, A2:2007/(R)2010, A3:2009, & A4:2009 (Consolidated Text) Dialysate for haemodialysis. ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators. ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and extracorporeal systems—Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters. ANSI/AAMI RD62:2006 and ANSI/AAMI RD62:2006/A1:2009 Water treatment equipment for haemodialysis applications. Jkt 223001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM Withdrawn. See 9–65. Withdrawn. See 9–66. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. 14MRN1 13634 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 Change I. Orthopedics 11–168 .......... ........................ 11–183 .......... ........................ ASTM F 1781–03 (Reapproved 2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants. ASTM F1875–98 (Reapproved 2009) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface. Reaffirmation. Reaffirmation. J. Physical Medicine 16–167 16–31 ............ 16–168 16–32 ............ 16–169 16–33 ............ 16–170 16–34 ............ 16–171 16–35 ............ 16–172 16–36 ............ 16–173 16–37 ............ 16–174 16–38 ............ 16–175 16–39 ............ 16–176 16–40 ............ 16–177 16–41 ............ 16–178 16–42 ............ mstockstill on DSKH9S0YB1PROD with NOTICES 16–30 ............ 16–179 16–43 ............ 16–180 16–44 ............ 16–181 VerDate Mar<15>2010 16:20 Mar 11, 2011 ISO 7176–9: Third edition, 2009–11–15 Wheelchairs—Part 9: Climatic tests for electric wheelchairs. RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability. RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs. RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakes. RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range. RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space. RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs. RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions. RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths. RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs. RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs. RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies. RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces. RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and control systems for electrically powered wheelchairs—Requirements and test methods. RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling. Jkt 223001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. 14MRN1 13635 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 16–45 ............ 16–182 16–46 ............ 16–183 16–47 ............ 16–184 16–48 ............ ........................ 16–49 ............ ........................ 16–160 .......... 16–185 16–161 .......... 16–186 Title of standard 1 Change RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts—Requirements and test methods. RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the performance of stand-up type wheelchairs. RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 22: Set-up procedures. ANSI/RESNA WC/Volume 1–1998, Section 93: Maximum Overall Dimensions. ANSI/RESNA WC/Volume 1–1998, Section 0: Nomenclature, Terms, and Definitions. RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters. ASME A18.1–2008 (Revision of ASME A18.1–2005) Safety Standard for Platform Lifts and Stairway Chairlifts. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn. Withdrawn. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. K. Radiology 12–122 .......... 12–217 12–36 ............ ........................ 12–183 .......... 12–218 IEC 62083 Edition 2.0:2009–09 Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems. IEC 60601–2–9 (1996–10) Medical electrical equipment—Part 2: Particular requirements for the safety of patient contact dosimeters used in radiotherapy with electrically connected radiation detectors—Ed. 2.0.. NEMA PS 3.1—3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. Withdrawn and replaced with newer version. Withdrawn. Withdrawn and replaced with newer version. L. Software/Informatics 13–4 .............. ........................ UL 1998 Standard for Safety Software in Programmable Components, Second Edition. Reaffirmation. M. Sterility 14–301 14–266 .......... 14–302 USP 33:2010 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. USP 33: 2010 <71> Sterility Tests ............................................................ 14–267 .......... 14–303 USP 33:2010 <85> Bacterial Endotoxins Test .......................................... 14–268 .......... 14–304 USP 33:2010 <151> Pyrogen Test ............................................................ 14–269 .......... 14–305 14–270 .......... 14–306 14–271 .......... 14–307 14–272 .......... 14–308 14–273 .......... 14–309 USP 33:2010 <161> Transfusion and Infusion Assemblies and Similar Medical Devices. USP 33:2010 Biological Indicators for Steam Sterilization, Self-Contained. USP 33:2010 Biological Indicator for Dry-Heat Sterilization, Paper Carrier. USP 33:2010 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier. USP 33:2010 Biological Indicator for Steam Sterilization, Paper Carrier 14–278 .......... mstockstill on DSKH9S0YB1PROD with NOTICES 14–265 .......... 14–310 1 All USP 33:2010 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer standard titles in this table conform to the style requirements of the respective organizations. III. Listing of New Entries In table 3 of this document, FDA provides the listing of new entries and VerDate Mar<15>2010 16:20 Mar 11, 2011 Jkt 223001 consensus standards added as modifications to the list of recognized PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 standards under Recognition List Number: 026. E:\FR\FM\14MRN1.SGM 14MRN1 13636 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Recognition No. Title of standard 1 Reference No. and date A. Anesthesia 1–84 .............. Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: Paediatric tracheostomy tubes TECHNICAL CORRIGENDUM 1. ISO 5366–3:2001 TECHNICAL CORRIGENDUM 1. B. Biocompatibility 2–163 ............ 2–164 ............ 2–165 ............ 2–166 ............ 2–167 ............ 2–168 ............ 2–169 ............ 2–170 ............ 2–171 ............ 2–172 ............ Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products. Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices. Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics. Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables. Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials. Biological evaluation of medical devices— Part 9: Framework for identification and quantification of potential degradation products. Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices. Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics. Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables. Biological evaluation of medical devices—Part 19: Physico-chemical, morphological, and topographical characterization of materials. ANSI/AAMI/ISO 10993–9:2009. ANSI/AAMI/ISO 10993–13:2010. ANSI/AAMI/ISO 10993–14:2001. ANSI/AAMI/ISO 10993–16:2010. ISO/TS 10993–19 First edition 2006–06–01. ISO 10993–9 Second edition 2009–12–15. ISO 10993–13 First edition 1998–11–15. ISO 10993–14 First edition 2001–11–15. ISO 10993–16 Second edition 2010–02–15. ANSI/AAMI/ISO TIR10993–19:2006. C. Cardiovascular 3–83 .............. 3–84 .............. 3–85 .............. 3–86 .............. 3–87 .............. 3–88 .............. 3–89 .............. 3–90 .............. 3–91 .............. 3–92 .............. 3–93 .............. 3–94 .............. Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices. Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses Amendment 1: Test methods. Cardiovascular implants—Endovascular devices—Part 2: Vascular stents. Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System. Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents. Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading. Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirements. Cardiovascular implants—Tubular vascular prostheses ........................... Cardiovascular implants—Cardiac valve prostheses ................................ Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices. Cardiovascular implants—Endovascular device—Part 1: Endovascular prostheses AMENDMENT 1: Test methods. Cardiovascular implants—Endovascular devices—Part 2: Vascular stents. ANSI/AAMI/ISO 14708–5:2010. ANSI/AAMI/ISO 25539–1:2003/A1:2005/(R)2009. ANSI/AAMI/ISO 25539–2:2008. ASTM F 2394–07. ASTM F 2477–07. ASTM F 2514–08. ISO 27186 First edition 2010–03–15. ISO 7198 First edition 1998–08–01. ISO 5840 Fourth edition 2005–03–01. ISO 14708–5 First edition 2010–02–01. ISO 25539–1 First edition 2001–11–13 AMENDMENT 1 2005–07–15. ISO 25539–2 First edition 2008–09–01. D. General 5–63 .............. mstockstill on DSKH9S0YB1PROD with NOTICES 5–64 .............. Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements. Small bore connectors for liquids and gases in healthcare applications—Part 1: General requirements. ISO 80369–1 First edition 2010–12–15. AAMI/ISO/FDS–1 80369–01 2010. E. Materials 8–196 ............ 8–197 ............ 8–198 ............ VerDate Mar<15>2010 Implants for surgery—Metallic materials—Part 1: Wrought stainless steel TECHNICAL CORRIGENDUM 1. Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy TECHNICAL CORRIGENDUM 1. Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants. 16:20 Mar 11, 2011 Jkt 223001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 ISO 5832–1:2007 TECHNICAL CORRIGENDUM 1 2008–04–15. ISO 5832–12:2007 TECHNICAL CORRIGENDUM 1 2008–09–15. ASTM F 2102–06e1. E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13637 TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Recognition No. Title of standard 1 8–199 ............ Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants. Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air. Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE). Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants. 8–200 ............ 8–201 ............ 8–202 ............ Reference No. and date ASTM F 2633–07. ASTM F 2003–02 (Reapproved 2008). ASTM F 2214–02 (Reapproved 2008). ASTM F 2183–02 (Reapproved 2008). F. Nanotechnology 18–1 .............. Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS). ASTM E 2490–09. G. Ophthalmic 10–62 ............ 10–63 ............ Ophthalmics—Ophthalmic Instruments—Tonometers .............................. Ophthalmic implants—Intraocular lenses—Guidance on assessment of the need for clinical investigation of intraocular lens design modifications. ANSI Z80.10–2009. ISO/TR 22979–2006. H. Radiology 12–219 .......... 12–220 .......... 12–221 .......... 12–222 .......... 12–223 .......... 12–224 .......... 12–225 .......... 12–226 .......... Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Characteristics of focal spots CORRIGENDUM 1. Safety of laser products—Part 1: Equipment classification and requirements CORRIGENDUM 1. Evaluation and routine testing in medical imaging departments—Part 3– 4: Acceptance tests—Imaging performance of dental X-ray equipment. Evaluation and routine testing in medical imaging departments—Part 3– 5: Acceptance tests—Imaging performance of computed tomography X-ray equipment. Evaluation and routine testing in medical imaging departments—Part 3– 5: Acceptance tests—Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1. Medical electrical equipment—Part 2–44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1. Computed Tomography Dose Check ........................................................ Evaluation and routine testing in medical imaging departments—Part 2– 6: Constancy tests—Imaging performance of computed tomography X-ray equipment. IEC 60336 (Fourth edition—2005). IEC 60825–1 (Second edition—2007). IEC 61223–3–4 First edition 2000–03. IEC 61223–3–5 First edition 2004–08. IEC 61223–3–5 (First edition 2004). IEC 60601–2–44 (Third edition—2009). NEMA XR 25 2010. IEC 61223–2–6 Second edition 2006–11. I. Tissue Engineering 15–25 ............ 15–26 ............ 1 All ASTM F2312—10 Standard Terminology Relating to Tissue Engineered Medical Products. ASTM F2211—04 Standard Classification for Tissue Engineered Medical Products (TEMPs). ASTM F2211–04. standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards mstockstill on DSKH9S0YB1PROD with NOTICES ASTM F2312–10. 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 https:// 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 VerDate Mar<15>2010 16:20 Mar 11, 2011 Jkt 223001 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 FD&C 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 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 E:\FR\FM\14MRN1.SGM 14MRN1 13638 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 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 notice announcing ‘‘Modification to the List of Recognized Standards, Recognition List Number: 026’’ will be available on the CDRH home page. You may access the CDRH home page at https://www.fda.gov/ MedicalDevices. You may access ‘‘Guidance on the Recognition and Use of Consensus Standards,’’ and the searchable database for ‘‘FDA Recognized Consensus Standards’’ at https://www.fda.gov/ MedicalDevices/DeviceRegulationand Guidance/Standards. This Federal Register document on modifications in FDA’s recognition of consensus standards is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. 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: 026. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register. Dated: March 8, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–5815 Filed 3–11–11; 8:45 am] mstockstill on DSKH9S0YB1PROD with NOTICES BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0135] Ensuring the Safety of Imported Foods and Animal Feed: Comparability of Food Safety Systems and Import Practices of Foreign Countries; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public hearing; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing a public hearing regarding new FDA initiatives for ensuring the safety of foods and animal feed imported into the United States. The purpose of the public hearing is to provide stakeholders the opportunity to discuss FDA’s use of international comparability assessments as a mechanism to enhance the safety of imported foods and animal feed and lessons learned through equivalence determinations. In addition, there will be a separate discussion of FDA’s efforts to gather information from regulators in other countries regarding the regulatory policies, practices, and programs they currently use to ensure the safety of foods and animal feed imported into their countries. In a separate notice published elsewhere in this issue of the Federal Register, FDA is announcing a 1-day public meeting to discuss implementation of the imports provisions found in the FDA Food Safety Modernization Act (FSMA). DATES: See ‘‘How to Participate in the Hearing’’ in the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: For questions about registration, to register orally, or to submit a notice of participation by mail, fax, or by e-mail: Courtney Treece, Planning Professionals Ltd., 1210 W. McDermott, suite 111, Allen, TX 75013, 704–258–4983, FAX: 469–854–6992, e-mail: ctreece@planningprofessionals.com. For questions about the hearing, if special accommodations are needed due to a disability, to request onsite parking, or to submit the full text, comprehensive outline, or summary of an oral presentation: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administation, 5100 Paint Branch Pkwy., College Park, MD 20740, 301– 436–1731, e-mail: Juanita.Yates@fda.hhs.gov. SUMMARY: SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:20 Mar 11, 2011 Jkt 223001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 I. Background The Federal Government and the food industry are pursuing proactive efforts to reduce the incidence of food borne illness. The President’s Food Safety Working Group (FSWG) has recommended that food regulators shift towards prioritizing prevention and move aggressively to implement sensible measures designed to prevent problems before they occur (Ref. 1). The newly enacted FSMA (Pub. L. 111–353) also embodies the principle of prevention by requiring those who produce and import food to have systems of preventive controls in place and empowering FDA to hold them accountable to meet their new responsibilities. FDA recognizes that to ensure the safety of imported foods and animal feed and fulfill its public health mission in a global age, it must embrace new approaches that take into account the entire supply chain and its complexity. Consistent with FSMA and the recommendation of the President’s FSWG, FDA is focusing on preventing problems at appropriate points along the global food supply chain. This public hearing is an opportunity for the Agency to obtain views from interested persons concerning certain key aspects of these food safety initiatives: (1) International comparability assessments and (2) gathering information on the policies, practices, and programs used by foreign regulators to ensure the safety of imported foods and animal feed. The public hearing will be conducted in accordance with part 15 (21 CFR part 15), as described in the following paragraphs. (See ‘‘Notice of Hearing Under Part 15’’ in section III of this document.) FDA’s initiatives discussed at the 2day public hearing align with and help support FSMA implementation. Day One of the hearing will open with a general discussion of FSMA from the perspectives of consumers, industry, legislators, and U.S. trading partners. Day Two will cover policies, practices, and programs used by foreign regulators to ensure the safety of imported foods and animal feed. In a separate notice published elsewhere in this issue of the Federal Register, FDA is announcing a 1-day public meeting to discuss implementation of the imports provisions found in title III of FSMA. II. Topics for Discussion at the Hearing A. Day One of Hearing: International Comparability Assessments Under FDA’s proposed model, FDA will consider the food safety system of a foreign country to be ‘‘comparable’’ to E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13631-13638]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5815]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 026

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: 026'' (Recognition List Number: 026), 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: 026'' 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, Silver Spring, MD
20993. 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. 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: 026 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, 301-796-
6574.

I. Background

Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C 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 as
follows:

Table 1--Previous Publications of Standard Recognition Lists
------------------------------------------------------------------------

-------------------------------------------------------------------------
February 25, 1998 (63 FR 9561).
October 16, 1998 (63 FR 55617).
July 12, 1999 (64 FR 37546).
November 15, 2000 (65 FR 69022).
May 7, 2001 (66 FR 23032).
January 14, 2002 (67 FR 1774).
October 2, 2002 (67 FR 61893).
April 28, 2003 (68 FR 22391).
March 8, 2004 (69 FR 10712).
June 18, 2004 (69 FR 34176).
October 4, 2004 (69 FR 59240).
May 27, 2005 (70 FR 30756).
November 8, 2005 (70 FR 67713).
March 31, 2006 (71 FR 16313).
June 23, 2006 (71 FR 36121).
November 3, 2006 (71 FR 64718).
May 21, 2007 (72 FR 28500).
September 12, 2007 (72 FR 52142).
December 19, 2007 (72 FR 71924).
September 9, 2008 (73 FR 52358).
March, 18, 2009 (74 FR 11586).
September 8, 2009 (74 FR 46203).
May 5, 2010 (75 FR 24711).
June 10, 2010 (75 FR 32943).
October 4, 2010 (75 FR 61148).
------------------------------------------------------------------------

[[Page 13632]]

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: 026

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: 026'' 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 recognition Title of standard Change
No. No. \1\
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-56............. .............. CGA V-7.1 1997 Reaffirmation.
(R2003) (2008)
Standard Method of
Determining
Cylinder Valve
Outlet Connections
for Medical Gases--
First Edition.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-96............. 2-162 ASTM F1903-10 Withdrawn and
Standard Practice replaced with
for Testing For newer version.
Biological
Responses to
Particles In Vitro.
2-117............ .............. ANSI/AAMI/ISO 10993- Extent of
3:2003/(R)2009 recognition.
Biological
evaluation of
medical devices--
Part 3: Tests for
genotoxicity,
carcinogenicity,
and reproductive
toxicity.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-54............. .............. ANSI/AAMI/ISO Reaffirmation.
7198:1998/2001/
(R)2010
Cardiovascular
implants--Tubular
vascular prostheses.
3-58............. .............. ANSI/AAMI/ISO Reaffirmation.
5840:2005/(R)2010
Cardiovascular
implants--Cardiac
valve prostheses.
3-66............. .............. ASTM F 2081-06 Device
Standard Guide for affected,
Characterization Processes
and Presentation of impacted, Type
the Dimensional of standard,
Attributes of CFR citation
Vascular Stents. and product
codes, and
Contact
person.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
4-89............. .............. ADA Specification Reaffirmation.
No. 53 Polymer-
Based Crowns and
Bridge Resins.
4-111............ .............. ADA Specification Withdrawn.
No. 13 Denture Cold-
Curing Repair
Resins: 1981
(Reaffirmed 2006).
4-112............ .............. ADA Specification Withdrawn.
No. 16 Dental
Impression Paste--
Zinc Oxide Eugenol
Type.
4-124............ 4-191 ANSI/ASA S3.22-2009 Withdrawn and
American National replaced with
Standard newer version.
Specification of
Hearing Aid
Characteristics.
4-127............ 4-192 ADA Specification 58 Withdrawn and
Root Canal Files, replaced with
Type H (Hedstrom) newer version.
2007.
4-138............ 4-193 ADA Specification Withdrawn and
No. 15 Artificial replaced with
Teeth for Dental newer version.
Prostheses.
4-148............ 4-194 ADA Specification Withdrawn and
No. 78 Dental replaced with
Obturating Cones. newer version.
4-158............ .............. ISO 10139-1:2005 Withdrawn
Dentistry--Soft duplicate. See
lining materials 4-189.
for removable
dentures--Part 1:
Materials for short-
term use Technical
Corrigendum 1:2006.
------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-144............ 6-243 ASTM D5712-10 Withdrawn and
Standard Test replaced with
Method for Analysis a newer
of Aqueous version.
Extractable Protein
in Natural Rubber
and Its Products
Using the Modified
Lowry Method.
6-145............ .............. ASTM D3578-05 Reaffirmation.
Standard
Specification for
Rubber Examination
Gloves.
6-149............ .............. ASTM D7160-05 Reaffirmation.
(Reapproved 2010)
Standard Practice
for Determination
of Expiration
Dating for Medical
Gloves.

[[Page 13633]]

6-150............ .............. ASTM D7161-05 Reaffirmation.
(Reapproved 2010)
Standard Practice
for Determination
of Real Time
Expiration Dating
of Mature Medical
Gloves Stored Under
Typical Warehouse
Conditions.
6-165............ .............. ASTM D6977-04 Reaffirmation.
(Reapproved 2010)
Standard
Specification for
Polychloroprene
Examination Gloves
for Medical
Application.
6-167............ 6-244 ASTM D6319-10 Withdrawn and
Standard replaced with
Specification for newer version.
Nitrile Examination
Gloves for Medical
Application.
6-169............ .............. ASTM D3772-01 Reaffirmation.
(Reapproved 2010)
Standard
Specification for
Natural Rubber
Finger Cots.
6-201............ 6-245 ISO 8536-4 Fifth Withdrawn and
edition 2010-10-01 replaced with
Infusion equipment newer version.
for medical use--
Part 4: Infusion
sets for single
use, gravity feed.
6-218............ 6-246 USP 33-NF 28 2010 Withdrawn and
<11> Nonabsorbable replaced with
Surgical Suture. newer version.
6-220............ 6-247 USP 33-NF 28 2010 Withdrawn and
Absorbable Surgical replaced with
Suture. newer version.
6-221............ 6-248 USP 33-NF 28 2010 Withdrawn and
<881> Tensile replaced with
Strength. newer version.
6-222............ 6-249 USP 33-NF 28 2010 Withdrawn and
<861> Suture- replaced with
Diameter. newer version.
6-223............ 6-250 USP 33-NF 28 2010 Withdrawn and
<871> Sutures-- replaced with
Needle Attachment. newer version.
6-224............ 6-251 USP 33 NF-28 2010 Withdrawn and
<11> Sterile Water replaced with
for Irrigation. newer version.
6-225............ 6-252 USP 33 NF-28 2010 Withdrawn and
<11> Heparin Lock replaced with
Flush Solution. newer version.
------------------------------------------------------------------------
F. IVD
------------------------------------------------------------------------
7-183............ .............. CLSI M38-A2 Withdrawn
Reference Method duplicate. See
for Broth Dilution 7-171.
Antifungal
Susceptibility
Testing of
Filamentous Fungi.
7-188............ 7-218 CLSI M45-A2 Methods Withdrawn and
for Antimicrobial replaced with
Dilution and Disk newer version.
Susceptibility
Testing of
Infrequently
Isolated or
Fastidious
Bacteria; Approved
Guideline--Second
Edition.
------------------------------------------------------------------------
G. Materials
------------------------------------------------------------------------
8-10............. .............. ASTM F603-00 Withdrawn.
Standard
Specification for
High-Purity Dense
Aluminum Oxide for
Surgical Implant
Application.
8-88............. 8-195 ASTM F2024-10 Withdrawn and
Standard Practice replaced with
for X-Ray newer version.
Diffraction
Determination of
Phase Content of
Plasma-Sprayed
Hydroxyapatite
Coatings.
8-101............ .............. ASTM F 2118--03 Reaffirmation.
(Reapproved 2009)
Standard Test
Method for Constant
Amplitude of Force
Controlled Fatigue
Testing of Acrylic
Bone Cement
Materials.
8-103............ .............. ASTM F1801--97 Reaffirmation.
(Reapproved
2009)[epsi]\1\
Standard Practice
for Corrosion
Fatigue Testing of
Metallic Implant
Materials.
8-107............ .............. ASTM F746--04 Reaffirmation.
(Reapproved 2009)
[epsi]\1\ Standard
Test Method for
Pitting or Crevice
Corrosion of
Metallic Surgical
Implant Materials.
8-117............ .............. ASTM F86--04 Reaffirmation.
(Reapproved 2009)
Standard Practice
for Surface
Preparation and
Marking of Metallic
Surgical Implants.
------------------------------------------------------------------------
H. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-47............. .............. AAMI RD16 Withdrawn. See
Cardiovascular 9-65.
implants and
artificial organs--
Hemodialyzers,
hemodiafilters.
9-48............. .............. AAMI RD17 Withdrawn. See
Cardiovascular 9-66.
implants and
artificial organs--
Extracorporeal
blood circuit for
hemodialyzers,
hemodiafilters, and
hemofilters.
9-50............. .............. ANSI/AAMI RD52:2004/ Reaffirmation.
(R)2010 and ANSI/
AAMI RD52:2004/
A1:2007/(R)2010,
A2:2007/(R)2010,
A3:2009, & A4:2009
(Consolidated Text)
Dialysate for
haemodialysis.
9-51............. 9-65 ANSI/AAMI/ISO Withdrawn and
8637:2010 replaced with
Cardiovascular newer version.
implants and
extracorporeal
systems--Hemodialyz
ers,
hemodiafilters,
hemofilters and
hemoconcentrators.
9-52............. 9-66 ANSI/AAMI/ISO Withdrawn and
8638:2010 replaced with
Cardiovascular newer version.
implants and
extracorporeal
systems--Extracorpo
real blood circuit
for hemodialyzers,
hemodiafilters and
hemofilters.
9-55............. .............. ANSI/AAMI RD62:2006 Reaffirmation.
and ANSI/AAMI
RD62:2006/A1:2009
Water treatment
equipment for
haemodialysis
applications.
------------------------------------------------------------------------

[[Page 13634]]

I. Orthopedics
------------------------------------------------------------------------
11-168........... .............. ASTM F 1781-03 Reaffirmation.
(Reapproved 2009)
Standard
Specification for
Elastomeric
Flexible Hinge
Finger Total Joint
Implants.
11-183........... .............. ASTM F1875-98 Reaffirmation.
(Reapproved 2009)
Standard Practice
for Fretting
Corrosion Testing
of Modular Implant
Interfaces: Hip
Femoral Head-Bore
and Cone Taper
Interface.
------------------------------------------------------------------------
J. Physical Medicine
------------------------------------------------------------------------
16-30............ 16-167 ISO 7176-9: Third Withdrawn and
edition, 2009-11-15 replaced with
Wheelchairs--Part newer version.
9: Climatic tests
for electric
wheelchairs.
16-31............ 16-168 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
1: Determination of
static stability.
16-32............ 16-169 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 2:
Determination of
dynamic stability
of electrically
powered wheelchairs.
16-33............ 16-170 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 3:
Determination of
effectiveness of
brakes.
16-34............ 16-171 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 4: Energy
consumption of
electrically
powered wheelchairs
and scooters for
determination of
theoretical
distance range.
16-35............ 16-172 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
5: Determination of
dimensions, mass
and maneuvering
space.
16-36............ 16-173 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 6:
Determination of
maximum speed,
acceleration and
deceleration of
electrically
powered wheelchairs.
16-37............ 16-174 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
7: Method of
Measurement of
Seating and Wheel
Dimensions.
16-38............ 16-175 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
8: Requirements and
test methods for
static, impact and
fatigue strengths.
16-39............ 16-176 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 9: Climatic
tests for
electrically
powered wheelchairs.
16-40............ 16-177 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 10:
Determination of
obstacle-climbing
ability of
electrically
powered wheelchairs.
16-41............ 16-178 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
11: Test dummies.
16-42............ 16-179 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
13: Determination
of coefficient of
friction of test
surfaces.
16-43............ 16-180 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 14: Power
and control systems
for electrically
powered
wheelchairs--Requir
ements and test
methods.
16-44............ 16-181 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
15: Requirements
for information
disclosure,
documentation and
labeling.

[[Page 13635]]

16-45............ 16-182 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
16: Resistance to
ignition of
upholstered parts--
Requirements and
test methods.
16-46............ 16-183 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
20: Determination
of the performance
of stand-up type
wheelchairs.
16-47............ 16-184 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
22: Set-up
procedures.
16-48............ .............. ANSI/RESNA WC/Volume Withdrawn.
1-1998, Section 93:
Maximum Overall
Dimensions.
16-49............ .............. ANSI/RESNA WC/Volume Withdrawn.
1-1998, Section 0:
Nomenclature,
Terms, and
Definitions.
16-160........... 16-185 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 21:
Requirements and
test methods for
electromagnetic
compatibility of
electrically
powered wheelchairs
and motorized
scooters.
16-161........... 16-186 ASME A18.1-2008 Withdrawn and
(Revision of ASME replaced with
A18.1-2005) Safety newer version.
Standard for
Platform Lifts and
Stairway Chairlifts.
------------------------------------------------------------------------
K. Radiology
------------------------------------------------------------------------
12-122........... 12-217 IEC 62083 Edition Withdrawn and
2.0:2009-09 Medical replaced with
electrical newer version.
equipment--Requirem
ents for the safety
of radiotherapy
treatment planning
systems.
12-36............ .............. IEC 60601-2-9 (1996- Withdrawn.
10) Medical
electrical
equipment--Part 2:
Particular
requirements for
the safety of
patient contact
dosimeters used in
radiotherapy with
electrically
connected radiation
detectors--Ed. 2.0..
12-183........... 12-218 NEMA PS 3.1--3.18 Withdrawn and
(2009) Digital replaced with
Imaging and newer version.
Communications in
Medicine (DICOM)
Set.
------------------------------------------------------------------------
L. Software/Informatics
------------------------------------------------------------------------
13-4............. .............. UL 1998 Standard for Reaffirmation.
Safety Software in
Programmable
Components, Second
Edition.
------------------------------------------------------------------------
M. Sterility
------------------------------------------------------------------------
14-265........... 14-301 USP 33:2010 <61> Withdrawn and
Microbiological replaced with
Examination of newer version.
Nonsterile
Products: Microbial
Enumeration Tests.
14-266........... 14-302 USP 33: 2010 <71> Withdrawn and
Sterility Tests. replaced with
newer version.
14-267........... 14-303 USP 33:2010 <85> Withdrawn and
Bacterial replaced with
Endotoxins Test. newer version.
14-268........... 14-304 USP 33:2010 <151> Withdrawn and
Pyrogen Test. replaced with
newer version.
14-269........... 14-305 USP 33:2010 <161> Withdrawn and
Transfusion and replaced with
Infusion Assemblies newer version.
and Similar Medical
Devices.
14-270........... 14-306 USP 33:2010 Withdrawn and
Biological replaced with
Indicators for newer version.
Steam
Sterilization, Self-
Contained.
14-271........... 14-307 USP 33:2010 Withdrawn and
Biological replaced with
Indicator for Dry- newer version.
Heat Sterilization,
Paper Carrier.
14-272........... 14-308 USP 33:2010 Withdrawn and
Biological replaced with
Indicator for newer version.
Ethylene Oxide
Sterilization,
Paper Carrier.
14-273........... 14-309 USP 33:2010 Withdrawn and
Biological replaced with
Indicator for Steam newer version.
Sterilization,
Paper Carrier.
14-278........... 14-310 USP 33:2010 <62> Withdrawn and
Microbiological replaced with
Examination of newer version.
Nonsterile
Products: Tests for
Specified
Microorganisms.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.

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: 026.

[[Page 13636]]

Table 3--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-84.................. Anaesthetic and ISO 5366-3:2001
respiratory equipment-- TECHNICAL
Tracheostomy tubes--Part CORRIGENDUM 1.
3: Paediatric
tracheostomy tubes
TECHNICAL CORRIGENDUM 1.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-163................. Biological evaluation of ANSI/AAMI/ISO 10993-
medical devices--Part 9: 9:2009.
Framework for
identification and
quantification of
potential degradation
products.
2-164................. Biological evaluation of ANSI/AAMI/ISO 10993-
medical devices--Part 13: 13:2010.
Identification and
quantification of
degradation products from
polymeric medical devices.
2-165................. Biological evaluation of ANSI/AAMI/ISO 10993-
medical devices--Part 14: 14:2001.
Identification and
quantification of
degradation products from
ceramics.
2-166................. Biological evaluation of ANSI/AAMI/ISO 10993-
medical devices--Part 16: 16:2010.
Toxicokinetic study
design for degradation
products and leachables.
2-167................. Biological evaluation of ISO/TS 10993-19
medical devices--Part 19: First edition 2006-
Physico-chemical, 06-01.
morphological and
topographical
characterization of
materials.
2-168................. Biological evaluation of ISO 10993-9 Second
medical devices-- Part 9: edition 2009-12-15.
Framework for
identification and
quantification of
potential degradation
products.
2-169................. Biological evaluation of ISO 10993-13 First
medical devices--Part 13: edition 1998-11-15.
Identification and
quantification of
degradation products from
polymeric medical devices.
2-170................. Biological evaluation of ISO 10993-14 First
medical devices--Part 14: edition 2001-11-15.
Identification and
quantification of
degradation products from
ceramics.
2-171................. Biological evaluation of ISO 10993-16 Second
medical devices--Part 16: edition 2010-02-15.
Toxicokinetic study
design for degradation
products and leachables.
2-172................. Biological evaluation of ANSI/AAMI/ISO
medical devices--Part 19: TIR10993-19:2006.
Physico-chemical,
morphological, and
topographical
characterization of
materials.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-83.................. Implants for surgery-- ANSI/AAMI/ISO 14708-
Active implantable 5:2010.
medical devices--Part 5:
Circulatory support
devices.
3-84.................. Cardiovascular implants-- ANSI/AAMI/ISO 25539-
Endovascular devices-- 1:2003/A1:2005/
Part 1: Endovascular (R)2009.
prostheses Amendment 1:
Test methods.
3-85.................. Cardiovascular implants-- ANSI/AAMI/ISO 25539-
Endovascular devices-- 2:2008.
Part 2: Vascular stents.
3-86.................. Standard Guide for ASTM F 2394-07.
Measuring Securement of
Balloon Expandable
Vascular Stent Mounted on
Delivery System.
3-87.................. Standard Test Methods for ASTM F 2477-07.
in vitro Pulsatile
Durability Testing of
Vascular Stents.
3-88.................. Standard Guide for Finite ASTM F 2514-08.
Element Analysis (FEA) of
Metallic Vascular Stents
Subjected to Uniform
Radial Loading.
3-89.................. Active implantable medical ISO 27186 First
devices--Four-pole edition 2010-03-15.
connector system for
implantable cardiac
rhythm management
devices--Dimensional and
test requirements.
3-90.................. Cardiovascular implants-- ISO 7198 First
Tubular vascular edition 1998-08-01.
prostheses.
3-91.................. Cardiovascular implants-- ISO 5840 Fourth
Cardiac valve prostheses. edition 2005-03-01.
3-92.................. Implants for surgery-- ISO 14708-5 First
Active implantable edition 2010-02-01.
medical devices--Part 5:
Circulatory support
devices.
3-93.................. Cardiovascular implants-- ISO 25539-1 First
Endovascular device--Part edition 2001-11-13
1: Endovascular AMENDMENT 1 2005-07-
prostheses AMENDMENT 1: 15.
Test methods.
3-94.................. Cardiovascular implants-- ISO 25539-2 First
Endovascular devices-- edition 2008-09-01.
Part 2: Vascular stents.
------------------------------------------------------------------------
D. General
------------------------------------------------------------------------
5-63.................. Small-bore connectors for ISO 80369-1 First
liquids and gases in edition 2010-12-15.
healthcare applications--
Part 1: General
requirements.
5-64.................. Small bore connectors for AAMI/ISO/FDS-1 80369-
liquids and gases in 01 2010.
healthcare applications--
Part 1: General
requirements.
------------------------------------------------------------------------
E. Materials
------------------------------------------------------------------------
8-196................. Implants for surgery-- ISO 5832-1:2007
Metallic materials--Part TECHNICAL
1: Wrought stainless CORRIGENDUM 1 2008-
steel TECHNICAL 04-15.
CORRIGENDUM 1.
8-197................. Implants for surgery-- ISO 5832-12:2007
Metallic materials--Part TECHNICAL
12: Wrought cobalt- CORRIGENDUM 1 2008-
chromium-molybdenum alloy 09-15.
TECHNICAL CORRIGENDUM 1.
8-198................. Standard Guide for ASTM F 2102-
Evaluating the Extent of 06[epsi]1.
Oxidation in Ultra-High-
Molecular-Weight
Polyethylene Fabricated
Forms Intended for
Surgical Implants.

[[Page 13637]]

8-199................. Standard Specification for ASTM F 2633-07.
Wrought Seamless Nickel-
Titanium Shape Memory
Alloy Tube for Medical
Devices and Surgical
Implants.
8-200................. Standard Practice for ASTM F 2003-02
Accelerated Aging of (Reapproved 2008).
Ultra-High Molecular
Weight Polyethylene after
Gamma Irradiation in Air.
8-201................. Standard Test Method for ASTM F 2214-02
In Situ Determination of (Reapproved 2008).
Network Parameters of
Crosslinked Ultra High
Molecular Weight
Polyethylene (UHMWPE).
8-202................. Standard Test Method for ASTM F 2183-02
Small Punch Testing of (Reapproved 2008).
Ultra-High Molecular
Weight Polyethylene Used
in Surgical Implants.
------------------------------------------------------------------------
F. Nanotechnology
------------------------------------------------------------------------
18-1.................. Standard Guide for ASTM E 2490-09.
Measurement of Particle
Size Distribution of
Nanomaterials in
Suspension by Photon
Correlation Spectroscopy
(PCS).
------------------------------------------------------------------------
G. Ophthalmic
------------------------------------------------------------------------
10-62................. Ophthalmics--Ophthalmic ANSI Z80.10-2009.
Instruments--Tonometers.
10-63................. Ophthalmic implants-- ISO/TR 22979-2006.
Intraocular lenses--
Guidance on assessment of
the need for clinical
investigation of
intraocular lens design
modifications.
------------------------------------------------------------------------
H. Radiology
------------------------------------------------------------------------
12-219................ Medical electrical IEC 60336 (Fourth
equipment--X-ray tube edition--2005).
assemblies for medical
diagnosis--Characteristic
s of focal spots
CORRIGENDUM 1.
12-220................ Safety of laser products-- IEC 60825-1 (Second
Part 1: Equipment edition--2007).
classification and
requirements CORRIGENDUM
1.
12-221................ Evaluation and routine IEC 61223-3-4 First
testing in medical edition 2000-03.
imaging departments--Part
3-4: Acceptance tests--
Imaging performance of
dental X-ray equipment.
12-222................ Evaluation and routine IEC 61223-3-5 First
testing in medical edition 2004-08.
imaging departments--Part
3-5: Acceptance tests--
Imaging performance of
computed tomography X-ray
equipment.
12-223................ Evaluation and routine IEC 61223-3-5 (First
testing in medical edition 2004).
imaging departments--Part
3-5: Acceptance tests--
Imaging performance of
computed tomography X-ray
equipment CORRIGENDUM 1.
12-224................ Medical electrical IEC 60601-2-44
equipment--Part 2-44: (Third edition--
Particular requirements 2009).
for the basic safety and
essential performance of
X-ray equipment for
computed tomography
CORRIGENDUM 1.
12-225................ Computed Tomography Dose NEMA XR 25 2010.
Check.
12-226................ Evaluation and routine IEC 61223-2-6 Second
testing in medical edition 2006-11.
imaging departments--Part
2-6: Constancy tests--
Imaging performance of
computed tomography X-ray
equipment.
------------------------------------------------------------------------
I. Tissue Engineering
------------------------------------------------------------------------
15-25................. ASTM F2312--10 Standard ASTM F2312-10.
Terminology Relating to
Tissue Engineered Medical
Products.
15-26................. ASTM F2211--04 Standard ASTM F2211-04.
Classification for Tissue
Engineered Medical
Products (TEMPs).
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.

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 https://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 FD&C 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

[[Page 13638]]

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 notice announcing ``Modification to the List of Recognized
Standards, Recognition List Number: 026'' will be available on the CDRH
home page. You may access the CDRH home page at https://www.fda.gov/MedicalDevices.
You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' at https://www.fd

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