Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 029, 50114-50121 [2012-20323]

Download as PDF 50114 Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES 23, 2012. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Comments: FDA is holding this public workshop through co-sponsorship with ASTM International to obtain information on test methods for establishing correlations between in vitro and in vivo degradation of absorbable devices. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is December 28, 2012. Regardless of attendance at the public workshop, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or electronic comments to https://www.regulations.gov. It is only necessary to send one set of comments. Please 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, and will be posted to the docket at https:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM– 1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at https:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select this public workshop from the posted events list). SUPPLEMENTARY INFORMATION: I. Background Recent studies have identified promising results for the use of absorbable materials in implantable devices for endovascular therapies such as fully absorbable cardiovascular stents where the stent platform degrades, in addition to absorbable coatings. The use of these materials for cardiovascular indications, however, poses new risks VerDate Mar<15>2010 16:25 Aug 17, 2012 Jkt 226001 due to the critical fatigue and mechanical loading demands that the implant must withstand and perform. Moreover, the optimal preclinical/bench testing paradigm to predict clinical performance of fully absorbable cardiovascular devices is not yet defined. This public workshop will discuss the use of absorbable materials (including synthetic polymers as well as erodible metals) in medical devices across a broad range of indications with the aim of defining successful and unsuccessful methods to predict clinical performance, and will subsequently apply lessons learned to unique challenges for cardiovascular indications. Therefore, we invite presenters to share their experience with respect to cardiovascular and noncardiovascular medical devices, both those that are fully absorbable and those with only a component or coating that is absorbable. This public workshop will bring together the expertise of academia and industry professionals to define test methods as well as to educate and inform industry, academia, and device regulators on the performance and predictability of absorbable medical device degradation. Workshop participants will seek to define the critical factors for preclinical/bench testing and clinical predictability. They will then apply lessons learned from marketed devices for non-cardiovascular indications to the emerging uses of absorbable devices to treat cardiovascular disease. II. Topics for Discussion at the Public Workshop Topics to be discussed at the public workshop include, but are not limited to: • Correlations of in vitro and in vivo absorption • Quantitative characterization of absorption kinetics • Test methods to identify interactions of absorption with mechanical loading • Test methods to assess mechanical performance of the absorbable product The lessons learned from both early cardiovascular and well-established non-cardiovascular device experiences will be presented. These lessons will be discussed in the context of emerging cardiovascular uses of absorbable materials as part of a panel session at the end of the workshop. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Dated: August 14, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–20322 Filed 8–17–12; 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: 029 AGENCY: 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 consensus standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 029’’ (Recognition List Number: 029), 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: 029’’ 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 email: 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 SUMMARY: E:\FR\FM\20AUN1.SGM 20AUN1 50115 Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 029 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3628, 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 of this document. TABLE 1—PREVIOUS PUBLICATION 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). March 14, 2011 (76 FR 13631). August 2, 2011 (76 FR 46300). March 16, 2012 (77 FR 15765). 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: 029 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: 029’’ 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. Biocompatibility 2–115 ............ 2–189 ........... 2–164 ............ 2–190 ........... 2–165 ............ ...................... ASTM F895–11 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity. ANSI/AAMI/ISO 10993–13:2010 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices. ANSI/AAMI/ISO 10993–14:2001/(R)2011 Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. B. Cardiovascular mstockstill on DSK4VPTVN1PROD with NOTICES 3–37 .............. 1–87 ............. 3–44 .............. 3–55 .............. ...................... ...................... 3–56 .............. ...................... VerDate Mar<15>2010 16:25 Aug 17, 2012 IEC 60601–2–23(1999–12) Medical electrical equipment—Part 2–23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment. ANSI/AAMI BP22:1994/(R)2011 Blood pressure transducers .................... ASTM F1830–97 (Reapproved 2005) Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps. ASTM F1841–97 (Reapproved 2005) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps. Jkt 226001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM Transferred to Anesthesia. Reaffirmation. Extent of recognition. Extent of recognition. 20AUN1 50116 Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 3–62 .............. 3–102 ........... Title of standard 1 Change IEC 60601–2–31 Edition 2.1 2011–09 Medical electrical equipment—Part 2–31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source. Withdrawn and replaced with newer version. C. General 5–28 .............. ...................... 5–30 .............. ...................... 5–40 .............. ...................... 5–52 .............. 5–71 ............. 5–56 .............. ...................... 5–59 .............. 5–72 ............. 5–61 .............. ...................... IEC 60601–1–2, (Second Edition, 2001), Medical Electrical Equipment— Part 1–2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests. ANSI/AAMI/IEC 60601–1–2:2001, Medical Electrical Equipment—Part 1– 2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests. ISO 14971 Second edition 2007–03–01, Medical devices—Application of risk management to medical devices. ANSI/AAMI ES60601–1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment— Part 1: General requirements for basic safety and essential performance (IEC 60601–1:2005, MOD). ISO 15223–2 First edition 2010–01–15, Medical devices—Symbols to be used with medical devices labels, labeling, and information to be supplied—Part 2: Symbol development, selection and validation. ISO/FDIS 15223–1 2012 Medical devices—Symbols to be used with medical device labels, labeling and information to be supplied—Part 1: General requirements. ANSI/AAMI/ISO 15223–1:2007, Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied— Part 1: General requirements. Withdrawn. Withdrawn. Extent of recognition. Withdrawn and replaced with new version. Contact person. Withdrawn and replaced with new version. Withdrawn. D. General Hospital/General Plastic Surgery ...................... 6–114 ............ 6–274 ........... 6–115 ............ 6–275 ........... 6–117 ............ ...................... 6–118 ............ ...................... 6–119 ............ 6–132 ............ ...................... ...................... 6–172 ............ 6–276 ........... 6–175 ............ ...................... 6–178 ............ ...................... 6–183 ............ ...................... 6–202 ............ ...................... 6–236 ............ mstockstill on DSK4VPTVN1PROD with NOTICES 6–110 ............ ...................... 6–237 ............ ...................... 6–238 ............ ...................... VerDate Mar<15>2010 16:25 Aug 17, 2012 ASTM F 882–84 (Reapproved 2002), Standard Performance and Safety Specification for Cryosurgical Medical Instruments. ISO 11608–1 Second edition 2012–04–01 Needle-based injection systems for medical use—Requirements and test methods—Part 1: Needle-based injection systems. ISO 11608–2 Second edition 2012–04–01 Needle-based injection systems for medical use—Requirements and test methods—Part 2: Needles. ASTM F2172–02 (Reapproved 2011), Standard Specification for Blood/ Intravenous Fluid/Irrigation Fluid Warmers. ASTM F2196–02, Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices. ANSI/AAMI BF7:1989/(R)2011 Blood transfusion microfilters .................... ISO 11810–1 First edition 2005–02–15, Lasers and laser-related equipment—Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers—Part 1: Primary ignition and penetration. ISO 8536–1 Fourth edition 2011–09–01 Infusion equipment for medical use—Part 1: Infusion glass bottles. ASTM D5151–06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6124–06 (Reapproved 2011) Standard Test Method for Residual Powder on Medical Gloves. ASTM D5250–06 (Reapproved 2011) Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. ISO 11810–2:2007, Lasers and laser-related equipment—Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers—Part 2: Secondary ignition. IEC 80601–2–59 Edition 1.0 2008–10 Medical electrical equipment—Part 2–59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening. IEC 80601–2–59 (First edition—2008) Medical electrical equipment— Part 2–59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening CORRIGENDUM1. IEC 80601–2–35 Edition 2.0 2009–10, Medical electrical equipment— Part 2–35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use. Jkt 226001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM Withdrawn. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Contact person. Withdrawn. See 6–238. Reaffirmation. Contact person. Withdrawn and replaced with newer version. Reaffirmation. Reaffirmation and Contact person. Reaffirmation and contact person. Title and contact person. Title and contact person. Title and contact person. Contact person. 20AUN1 50117 Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 6–241 ............ ...................... 6–242 ............ ...................... 6–245 ............ ...................... 6–273 ............ ...................... Title of standard 1 Change ISO 1135–4 Fourth edition 2010–04–15, Transfusion equipment for medical use—Part 4: Transfusion sets for single use. ISO 8536–2 Third edition 2010–03–15, Infusion equipment for medical use—Part 2: Closures for infusion bottles. ISO 8536–4 Fifth edition 2010–10–01, Infusion equipment for medical use—Part 4: Infusion sets for single use, gravity feed. ISO 23908 First edition 2011–06–11, Sharps injury protection—Requirements and test methods—Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling. Contact person. Contact person. Contact person. Contact person. E. In Vitro Diagnostics 7–54 .............. ...................... 7–76 .............. ...................... 7–146 ............ ...................... 7–148 ............ ...................... 7–157 ............ 7–228 ........... 7–171 ............ ...................... 7–179 ............ ...................... 7–184 ............ ...................... 7–195 ............ 7–229 ........... 7–196 ............ 7–230 ........... 7–197 ............ ...................... 7–198 ............ ...................... 7–200 ............ ...................... 7–215 ............ ...................... 7–216 ............ 7–231 ........... 7–217 ............ ...................... 7–218 ............ ...................... CLSI D12–A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved Guideline. NCCLS M15–A, Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline. CLSI M6–A2, Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition. CLSI M28–A2, Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline—Second Edition. CLSI M11–A8, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. CLSI M38–A2, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard—Second Edition. CLSI M27–S3, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Third Informational Supplement. CLSI M40–A, Quality Control of Microbiological Transport Systems; Approved Standard. CLSI M02–A11, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Eleventh Edition. CLSI M07–A9, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Ninth Edition. CLSI M35–A2, Abbreviated Identification of Bacteria and Yeast; Approved Guideline—Second Edition. CLSI M23–A3, Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline—Third Edition. CLSI M48–A, Laboratory Detection and Identification of Mycobacteria; Approved Guideline. CLSI M44–A2, Method for Antifungal Disk Diffusion Susceptibility Testing of Yeast; Approved Guideline-Second Edition. CLSI M100–S22, Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement. CLSI M44–S3, Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement. CLSI M45–A2, Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition. Withdrawn. Contact person and type of standard. Contact person and title. Contact person and title. Withdrawn and replaced with newer version. Contact person and title. Contact person and title. Contact person and title. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Contact person and title. Contact person and title. Contact person and title. Contact person. Withdrawn and replaced with newer version. Contact person. Contact person. F. Materials 8–216 ........... 8–111 ............ mstockstill on DSK4VPTVN1PROD with NOTICES 8–108 ............ ...................... 8–112 ............ ...................... 8–113 ............ ...................... 8–127 ............ ...................... 8–128 ............ ...................... VerDate Mar<15>2010 16:25 Aug 17, 2012 ASTM F1295–11 Standard Specification for Wrought Titanium6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700). ASTM F1160–05 (Reapproved 2011) Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings. ASTM F1044–05 (Reapproved 2011) Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings. ASTM F1147–05 (Reapproved 2011) Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings. ISO 5834–2:2006, Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded forms. ASTM F2213–06 (Reapproved 2011) Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment. Jkt 226001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM Withdrawn and replaced with newer version. Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn. See 8–208. Reaffirmation ance. 20AUN1 and relevant guid- 50118 Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 8–130 ............ 8–217 ........... 8–131 ............ 8–218 ........... 8–164 ............ 8–219 ........... 8–174 ............ 8–220 ........... 8–180 ............ 8–221 ........... 8–182 ............ 8–222 ........... 8–186 ............ 8–223 ........... 8–210 ............ 8–227 ........... Title of standard 1 Change ASTM F620–11 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition. ASTM F799–11 Standard Specification for Cobalt-28Chromium6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539). ASTM F136–11 Standard Specification for Wrought Titanium6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). ASTM F629–11 Standard Practice for Radiography of Cast Metallic Surgical Implants. ASTM F2066–11 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150). ASTM F1537–11 Standard Specification for Wrought Cobalt28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539). ASTM F2759–11 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices. ASTM F2182–11a Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging. 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. G. Orthopedics 11–175 .......... ...................... 11–185 .......... ...................... 11–186 .......... 11–235 ......... 11–195 .......... ...................... 11–203 .......... ...................... 11–220 .......... ...................... 11–230 .......... 11–236 ......... ASTM F1582–98 (Reapproved 2011) Standard Terminology Relating to Spinal Implants. ASTM F2267–04 (Reapproved 2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. ASTM F2077–11 Test Methods For Intervertebral Body Fusion Devices ASTM F1612–95 (2005), Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion. ASTM F1541–02 (Reapproved 2011) Standard Specification and Test Methods for External Skeletal Fixation Devices. ASTM F2068–09, Standard Specification for Femoral Prostheses—Metallic Implants. ASTM F1717–11a Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn. See 11–225. Reaffirmation and contact person. Extent of recognition and CFR citations. Withdrawn and replaced with newer version. H. Physical Medicine 16–172 .......... ...................... 16–186 .......... 16–189 ......... ANSI/RESNA WC/Volume 1—1998, Section 5: Determination of Overall Dimensions, Mass, and Turning Space—Wheelchair. ASME A18.1–2011 (Revision of ASME A18.1–2008) Safety Standard for Platform Lifts and Stairway Chairlifts. Duplicate. See 16–188. Withdrawn and replaced with newer version. I. Radiology ...................... ANSI/IESNA RP–27.2–00 Recommended Practice for Photobiological Safety for Lamps & Lamp Systems—Measurement Techniques. 12–153 .......... ...................... ANSI/IESNA RP–27.1–05 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General Requirements. 12–179 .......... mstockstill on DSK4VPTVN1PROD with NOTICES 12–102 .......... ...................... ANSI/IESNA RP–27.3–07 Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and Labeling. CFR citation and product codes, devices affected, processes impacted, and contact person. CFR citation and product codes, devices affected, processes impacted, and contact person. Extent of recognition, CFR citation and product codes, devices affected, processes impacted, type of standard, contact person, and relevant guidance. J. Software/Informatics 13–8 .............. VerDate Mar<15>2010 ...................... 18:24 Aug 17, 2012 IEC 62304 First edition 2006–05 Medical device software—Software life cycle processes. Jkt 226001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM Extent of recognition. 20AUN1 50119 Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 Change K. Sterility 14–55 ............ 14–358 ......... 14–123 .......... 14–359 ......... 14–227 .......... ...................... 14–229 .......... ...................... 14–264 .......... 14–277 .......... ...................... ...................... 14–292 .......... 14–360 ......... 14–311 .......... ...................... 1 All ANSI/AAMI/ISO 14160:2011 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices. ASTM F2096–11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test). ANSI/AAMI/ISO 11737–1:2006 (R) 2011, Sterilization of health care products—Microbiological methods—Part 1: Determination of the population of microorganisms on product. ASTM F1980–07 (Reapproved 2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. AAMI/ANSI ST8:2008, Hospital steam sterilizers ....................................... ISO TS 17665–2:2009, Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ISO 17665–1. ANSI/AAMI ST72:2011 Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing. AAMI/ANSI ST55:2010, Table-top steam sterilizers ................................... Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation and contact person. Reaffirmation. Contact person. Extent of recognition and contact person. Withdrawn and replaced with newer version. Contact person. standard titles in this table conform to the style requirements of the respective organizations. 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: 029. TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Recognition No. Title of standard 1 Reference No. and date A. Anesthesia 1–86 ............. 1–87 ............. 1–88 ............. 1–89 ............. Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systems. Medical electrical equipment—Part 2–23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment. Medical electrical equipment—Part 2–12: Particular requirements for basic safety and essential performance of critical care ventilators. Medical electrical equipment—Part 2–12: Particular requirements for basic safety and essential performance of critical care ventilators. ISO 8185 Third edition 2007–07–01. 60601–2–23 Edition 3.0 2011–02. ISO 80601–2–12 First edition 2011–04– 15. ISO 80601–2–12:2011 TECHNICAL CORRIGENDUM 1. B. Cardiovascular 3–101 ........... 3–103 ........... 3–104 ........... Medical electrical equipment—Part 2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. Cardiovascular implants—Endovascular devices—Part 3: Vena cava filters .............. Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices. ANSI/AAMI/IEC 60601–2–27:2011. ISO 25539–3 First edition 2011–12–01. ASTM F2914–12. C. General Hospital/General Plastic Surgery 6–277 ........... Prefilled syringes—Part 4: Glass barrels for injectables .............................................. 6–278 ........... 6–279 ........... Prefilled syringes—Part 5: Plunger stoppers for injectables ........................................ Medical electrical equipment—Part 2–19: Particular requirements for the basic safety and essential performance of infant incubators CORRIGENDUM 1. Medical electrical equipment—Part 2–20: Particular requirements for the basic safety and essential performance of infant transport incubators CORRIGENDUM 1. Medical electrical equipment—Part 2–35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use CORRIGENDUM 1. mstockstill on DSK4VPTVN1PROD with NOTICES 6–280 ........... 6–281 ........... ISO 11040–4 Second edition 2007–02– 01. ISO 11040–5 Third edition 2012–01–15. IEC 60601–2–19 (Second edition—2009). IEC 60601–2–20 (Second edition—2009). IEC 80601–2–35 (Second edition—2009). D. Materials 8–224 ........... VerDate Mar<15>2010 Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-MolecularWeight Polyethylene Fabricated Forms Intended for Surgical Implants. 16:25 Aug 17, 2012 Jkt 226001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 ASTM F2102—06 Ö1. E:\FR\FM\20AUN1.SGM 20AUN1 50120 Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Recognition No. Title of standard 1 8–225 ........... Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air. Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application. 8–226 ........... Reference No. and date ASTM F2003—02 (Reapproved 2008). ASTM F603—12. E. OB–GYN/Gastroenterology 9–75 ............. 9–76 ............. 9–77 ............. 9–78 ............. Optics and Optical instruments—Medical endoscopes and endoscopic accessories—Part 3: Determination of field of view and direction of view of endoscopes with optics. Water for haemodialysis and related therapies ............................................................ Guidance for the preparation and quality management of fluids for haemodialysis and related therapies. Quality of dialysis fluid for haemodialysis and related therapies ................................. ISO 8600–3 First edition 1997–07–01. ISO 13959 Second edition 2009–04–15. ISO 23500 First edition 2011–05–15. ISO 11663 First edition 2009–04–15. F. Ophthalmic 10–73 ........... 10–74 ........... American National Standard for Ophthalmics—Instruments—General-Purpose Clinical Visual Acuity Charts. Ophthalmic instruments—Fundus cameras .................................................................. ANSI Z80.21–2010. ISO 10940 Second edition 2009–08–01. G. Orthopedic 11–237 ......... 11–238 ......... 11–239 ......... 11–240 ......... 11–241 ......... 11–242 ......... 11–243 ......... Implants for surgery—Partial and total hip joint prostheses—Part 6: Determination of endurance properties of head and neck region of stemmed femoral components. Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials. Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads. Standard Specification and Test Method for Metallic Bone Plates .............................. Standard Specification and Test Methods for Metallic Medical Bone Screws ............. Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments. Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs. ISO 7206–6 First edition 1992–03–l5. ASTM F 2033–12. ASTM F2345–03 (Reapproved 2008). ASTM F382–99 (Reapproved 2008). ASTM F543–07 Ö1. ASTM F1839–08 Ö2. ASTM F2346–05 (Reapproved 2011). H. Radiology 12–249 ......... Photobiological safety of lamps and lamp systems ...................................................... IEC 62471 First edition 2006–07. I. Software/Informatics 13–31 ........... 13–32 ........... Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard. Medical device software—Software life cycle processes ............................................. CLSI AUTO12–A. ANSI/AAMI/IEC 62304:2006. J. Sterility 14–361 ......... Sterilization of health care products—Liquid chemical sterilizing agents for singleuse medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices. ISO 14160 Second edition 2011–07–01. mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 16:25 Aug 17, 2012 Jkt 226001 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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 E:\FR\FM\20AUN1.SGM 20AUN1 Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices the device(s) that would be addressed by a declaration of conformity. DEPARTMENT OF HEALTH AND HUMAN SERVICES VI. Electronic Access Food and Drug Administration You may obtain a copy of ‘‘Guidance on the Recognition and Use of Consensus Standards’’ by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards-related documents. After publication in the Federal Register, this notice announcing ‘‘Modification to the List of Recognized Standards, Recognition List Number: 029’’ 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 mstockstill on DSK4VPTVN1PROD with NOTICES Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) either electronic or written comments regarding this document. 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: 029. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register. Dated: August 14, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–20323 Filed 8–17–12; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 16:25 Aug 17, 2012 Jkt 226001 50121 Dated: August 9, 2012. Karen Midthun, Director, Center for Biologics Evaluation and Research. [FR Doc. 2012–20280 Filed 8–17–12; 8:45 am] [Docket No. FDA–2012–N–0840] BILLING CODE 4160–01–P Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70 DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for DEXTRAN 70 (6% Dextran 70 and 0.9% NaCl or/5% Dextrose 500 mL Glass Bottle) held by Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045. Hospira, Inc., has notified the Agency in writing that this product is no longer marketed and has requested that approval of the application be withdrawn. SUMMARY: DATES: Effective August 20, 2012. FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301–827–6210. Hospira, Inc., has requested that FDA withdraw approval of NDA 080–819, DEXTRAN 70 (6% Dextran 70 and 0.9% NaCl or/ 5% Dextrose 500 mL Glass Bottle) under the process in § 314.150(c)(21 CFR 314.150(c)), stating that the product is no longer marketed. By its own request, Hospira, Inc., has also waived its opportunity for a hearing provided under § 314.150(a). Withdrawal of approval of an application under § 314.150(c) is without prejudice to refiling. Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Biologics Evaluation and Research, by the Commissioner of Food and Drugs, approval of NDA 080– 819, DEXTRAN 70 [6% Dextran 70 and 0.9% NaCl or/5% Dextrose 500 mL Glass Bottle], and all amendments and supplements thereto, is hereby withdrawn, effective August 20, 2012. Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). SUPPLEMENTARY INFORMATION: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Indian Health Service Office of Direct Service and Contracting Tribes National Indian Health Outreach and Education Program Funding Opportunity Announcement Type: New Limited Competition. Funding Announcement Number: HHS–2012–IHS–NIHOE–0003. Catalog of Federal Domestic Assistance Number: 93.933. Key Dates Application Deadline Date: September 10, 2012. Review Date: September 12, 2012. Earliest Anticipated Start Date: September 30, 2012. I. Funding Opportunity Description Statutory Authority The Indian Health Service (IHS) is accepting competitive cooperative agreement applications for the Office of Direct Service and Contracting Tribes on the National Indian Health Outreach and Education (NIHOE–III) program funding opportunity that includes outreach and education activities on the following: The Patient Protection and Affordable Care Act, Public Law 111– 148 (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010, Public Law 111–152, collectively known as the Affordable Care Act (ACA) and the Indian Health Care Improvement Act (IHCIA), as amended. This national outreach and educational program is authorized under the Snyder Act, codified at 25 U.S.C. 13, and the Transfer Act, codified at 42 U.S.C. 2001(a). This program is described in the Catalog of Federal Domestic Assistance under CFDA number 93.933. Background The NIHOE–III programs carry out health program objectives in the American Indian/Alaska Native (AI/AN) community in the interest of improving Indian health care for all 566 Federallyrecognized Tribes including Tribal governments operating their own health care delivery systems through selfdetermination contracts and compacts E:\FR\FM\20AUN1.SGM 20AUN1

Agencies

[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Pages 50114-50121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20323]

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

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: 029

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: 029'' (Recognition List Number: 029), 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: 029'' 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 email:
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

[[Page 50115]]

VI of this document for electronic access to the searchable database
for the current list of FDA recognized consensus standards, including
Recognition List Number: 029 modifications and other standards related
information.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3628, 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 of this
document.

Table 1--Previous Publication 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).
March 14, 2011 (76 FR 13631).
August 2, 2011 (76 FR 46300).
March 16, 2012 (77 FR 15765).
------------------------------------------------------------------------

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: 029

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: 029'' 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 recognition
Old recognition No. No. Title of standard \1\ Change
----------------------------------------------------------------------------------------------------------------
A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-115..................... 2-189..................... ASTM F895-11 Standard Test Withdrawn and replaced
Method for Agar Diffusion with newer version.
Cell Culture Screening for
Cytotoxicity.
2-164..................... 2-190..................... ANSI/AAMI/ISO 10993-13:2010 Withdrawn and replaced
Biological evaluation of with newer version.
medical devices--Part 13:
Identification and
quantification of degradation
products from polymeric
medical devices.
2-165..................... .......................... ANSI/AAMI/ISO 10993-14:2001/ Reaffirmation.
(R)2011 Biological evaluation
of medical devices--Part 14:
Identification and
quantification of degradation
products from ceramics.
----------------------------------------------------------------------------------------------------------------
B. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-37...................... 1-87...................... IEC 60601-2-23(1999-12) Transferred to
Medical electrical equipment-- Anesthesia.
Part 2-23: Particular
requirements for the safety,
including essential
performance, of
transcutaneous partial
pressure monitoring equipment.
3-44...................... .......................... ANSI/AAMI BP22:1994/(R)2011 Reaffirmation.
Blood pressure transducers.
3-55...................... .......................... ASTM F1830-97 (Reapproved Extent of recognition.
2005) Standard Practice for
Selection of Blood for in
vitro Evaluation of Blood
Pumps.
3-56...................... .......................... ASTM F1841-97 (Reapproved Extent of recognition.
2005) Standard Practice for
Assessment of Hemolysis in
Continuous Flow Blood Pumps.

[[Page 50116]]

3-62...................... 3-102..................... IEC 60601-2-31 Edition 2.1 Withdrawn and replaced
2011-09 Medical electrical with newer version.
equipment--Part 2-31:
Particular requirements for
the basic safety and
essential performance of
external cardiac pacemakers
with internal power source.
----------------------------------------------------------------------------------------------------------------
C. General
----------------------------------------------------------------------------------------------------------------
5-28...................... .......................... IEC 60601-1-2, (Second Withdrawn.
Edition, 2001), Medical
Electrical Equipment--Part 1-
2: General Requirements for
Safety--Collateral Standard:
Electromagnetic
Compatibility--Requirements
and Tests.
5-30...................... .......................... ANSI/AAMI/IEC 60601-1-2:2001, Withdrawn.
Medical Electrical Equipment--
Part 1-2: General
Requirements for Safety--
Collateral Standard:
Electromagnetic
Compatibility--Requirements
and Tests.
5-40...................... .......................... ISO 14971 Second edition 2007- Extent of recognition.
03-01, Medical devices--
Application of risk
management to medical devices.
5-52...................... 5-71...................... ANSI/AAMI ES60601-1:2005/ Withdrawn and replaced
(R)2012 and C1:2009/(R)2012 with new version.
and A2:2010/(R)2012
(Consolidated Text), Medical
electrical equipment--Part 1:
General requirements for
basic safety and essential
performance (IEC 60601-
1:2005, MOD).
5-56...................... .......................... ISO 15223-2 First edition 2010- Contact person.
01-15, Medical devices--
Symbols to be used with
medical devices labels,
labeling, and information to
be supplied--Part 2: Symbol
development, selection and
validation.
5-59...................... 5-72...................... ISO/FDIS 15223-1 2012 Medical Withdrawn and replaced
devices--Symbols to be used with new version.
with medical device labels,
labeling and information to
be supplied--Part 1: General
requirements.
5-61...................... .......................... ANSI/AAMI/ISO 15223-1:2007, Withdrawn.
Medical devices--Symbols to
be used with medical device
labels, labeling, and
information to be supplied--
Part 1: General requirements.
----------------------------------------------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-110..................... .......................... ASTM F 882-84 (Reapproved Withdrawn.
2002), Standard Performance
and Safety Specification for
Cryosurgical Medical
Instruments.
6-114..................... 6-274..................... ISO 11608-1 Second edition Withdrawn and replaced
2012-04-01 Needle-based with newer version.
injection systems for medical
use--Requirements and test
methods--Part 1: Needle-based
injection systems.
6-115..................... 6-275..................... ISO 11608-2 Second edition Withdrawn and replaced
2012-04-01 Needle-based with newer version.
injection systems for medical
use--Requirements and test
methods--Part 2: Needles.
6-117..................... .......................... ASTM F2172-02 (Reapproved Contact person.
2011), Standard Specification
for Blood/Intravenous Fluid/
Irrigation Fluid Warmers.
6-118..................... .......................... ASTM F2196-02, Standard Withdrawn. See 6-238.
Specification for Circulating
Liquid and Forced Air Patient
Temperature Management
Devices.
6-119..................... .......................... ANSI/AAMI BF7:1989/(R)2011 Reaffirmation.
Blood transfusion
microfilters.
6-132..................... .......................... ISO 11810-1 First edition 2005- Contact person.
02-15, Lasers and laser-
related equipment--Test
method and classification for
the laser-resistance of
surgical drapes and/or
patient-protective covers--
Part 1: Primary ignition and
penetration.
6-172..................... 6-276..................... ISO 8536-1 Fourth edition 2011- Withdrawn and replaced
09-01 Infusion equipment for with newer version.
medical use--Part 1: Infusion
glass bottles.
6-175..................... .......................... ASTM D5151-06 (Reapproved Reaffirmation.
2011) Standard Test Method
for Detection of Holes in
Medical Gloves.
6-178..................... .......................... ASTM D6124-06 (Reapproved Reaffirmation and
2011) Standard Test Method Contact person.
for Residual Powder on
Medical Gloves.
6-183..................... .......................... ASTM D5250-06 (Reapproved Reaffirmation and
2011) Standard Specification contact person.
for Poly(vinyl chloride)
Gloves for Medical
Application.
6-202..................... .......................... ISO 11810-2:2007, Lasers and Title and contact
laser-related equipment--Test person.
method and classification for
the laser-resistance of
surgical drapes and/or
patient-protective covers--
Part 2: Secondary ignition.
6-236..................... .......................... IEC 80601-2-59 Edition 1.0 Title and contact
2008-10 Medical electrical person.
equipment--Part 2-59:
Particular requirements for
the basic safety and
essential performance of
screening thermographs for
human febrile temperature
screening.
6-237..................... .......................... IEC 80601-2-59 (First edition-- Title and contact
2008) Medical electrical person.
equipment--Part 2-59:
Particular requirements for
the basic safety and
essential performance of
screening thermographs for
human febrile temperature
screening CORRIGENDUM1.
6-238..................... .......................... IEC 80601-2-35 Edition 2.0 Contact person.
2009-10, Medical electrical
equipment--Part 2-35:
Particular requirements for
the basic safety and
essential performance of
heating devices using
blankets, pads or mattresses
and intended for heating in
medical use.

[[Page 50117]]

6-241..................... .......................... ISO 1135-4 Fourth edition 2010- Contact person.
04-15, Transfusion equipment
for medical use--Part 4:
Transfusion sets for single
use.
6-242..................... .......................... ISO 8536-2 Third edition 2010- Contact person.
03-15, Infusion equipment for
medical use--Part 2: Closures
for infusion bottles.
6-245..................... .......................... ISO 8536-4 Fifth edition 2010- Contact person.
10-01, Infusion equipment for
medical use--Part 4: Infusion
sets for single use, gravity
feed.
6-273..................... .......................... ISO 23908 First edition 2011- Contact person.
06-11, Sharps injury
protection--Requirements and
test methods--Sharps
protection features for
single-use hypodermic
needles, introducers for
catheters and needles used
for blood sampling.
----------------------------------------------------------------------------------------------------------------
E. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-54...................... .......................... CLSI D12-A2, Immunoprecipitin Withdrawn.
Analyses: Procedures for
Evaluating the Performance of
Materials--Second Edition;
Approved Guideline.
7-76...................... .......................... NCCLS M15-A, Laboratory Contact person and type
Diagnosis of Blood-borne of standard.
Parasitic Diseases; Approved
Guideline.
7-146..................... .......................... CLSI M6-A2, Protocols for Contact person and
Evaluating Dehydrated Mueller- title.
Hinton Agar; Approved
Standard--Second Edition.
7-148..................... .......................... CLSI M28-A2, Procedures for Contact person and
the Recovery and title.
Identification of Parasites
From the Intestinal Tract;
Approved Guideline--Second
Edition.
7-157..................... 7-228..................... CLSI M11-A8, Methods for Withdrawn and replaced
Antimicrobial Susceptibility with newer version.
Testing of Anaerobic
Bacteria; Approved Standard-
Eighth Edition.
7-171..................... .......................... CLSI M38-A2, Reference Method Contact person and
for Broth Dilution Antifungal title.
Susceptibility Testing of
Filamentous Fungi; Approved
Standard--Second Edition.
7-179..................... .......................... CLSI M27-S3, Reference Method Contact person and
for Broth Dilution Antifungal title.
Susceptibility Testing of
Yeasts; Third Informational
Supplement.
7-184..................... .......................... CLSI M40-A, Quality Control of Contact person and
Microbiological Transport title.
Systems; Approved Standard.
7-195..................... 7-229..................... CLSI M02-A11, Performance Withdrawn and replaced
Standards for Antimicrobial with newer version.
Disk Susceptibility Tests;
Approved Standard--Eleventh
Edition.
7-196..................... 7-230..................... CLSI M07-A9, Methods for Withdrawn and replaced
Dilution Antimicrobial with newer version.
Susceptibility Tests for
Bacteria That Grow
Aerobically; Approved
Standard--Ninth Edition.
7-197..................... .......................... CLSI M35-A2, Abbreviated Contact person and
Identification of Bacteria title.
and Yeast; Approved
Guideline--Second Edition.
7-198..................... .......................... CLSI M23-A3, Development of In Contact person and
Vitro Susceptibility Testing title.
Criteria and Quality Control
Parameters; Approved
Guideline--Third Edition.
7-200..................... .......................... CLSI M48-A, Laboratory Contact person and
Detection and Identification title.
of Mycobacteria; Approved
Guideline.
7-215..................... .......................... CLSI M44-A2, Method for Contact person.
Antifungal Disk Diffusion
Susceptibility Testing of
Yeast; Approved Guideline-
Second Edition.
7-216..................... 7-231..................... CLSI M100-S22, Performance Withdrawn and replaced
Standards for Antimicrobial with newer version.
Susceptibility Testing;
Twenty-Second Informational
Supplement.
7-217..................... .......................... CLSI M44-S3, Zone Diameter Contact person.
Interpretive Standards,
Corresponding Minimal
Inhibitory Concentration
(MIC) Interpretive
Breakpoints, and Quality
Control Limits for Antifungal
Disk Diffusion Susceptibility
Testing of Yeasts; Third
Informational Supplement.
7-218..................... .......................... CLSI M45-A2, Methods for Contact person.
Antimicrobial Dilution and
Disk Susceptibility Testing
of Infrequently Isolated or
Fastidious Bacteria; Approved
Guideline--Second Edition.
----------------------------------------------------------------------------------------------------------------
F. Materials
----------------------------------------------------------------------------------------------------------------
8-108..................... 8-216..................... ASTM F1295-11 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Titanium-6Aluminum-7Niobium
Alloy for Surgical Implant
Applications (UNS R56700).
8-111..................... .......................... ASTM F1160-05 (Reapproved Reaffirmation.
2011) Standard Test Method
for Shear and Bending Fatigue
Testing of Calcium Phosphate
and Metallic Medical and
Composite Calcium Phosphate/
Metallic Coatings.
8-112..................... .......................... ASTM F1044-05 (Reapproved Reaffirmation.
2011) Standard Test Method
for Shear Testing of Calcium
Phosphate Coatings and
Metallic Coatings.
8-113..................... .......................... ASTM F1147-05 (Reapproved Reaffirmation.
2011) Standard Test Method
for Tension Testing of
Calcium Phosphate and
Metallic Coatings.
8-127..................... .......................... ISO 5834-2:2006, Implants for Withdrawn. See 8-208.
surgery--Ultra-high-molecular-
weight polyethylene--Part 2:
Moulded forms.
8-128..................... .......................... ASTM F2213-06 (Reapproved Reaffirmation and
2011) Standard Test Method relevant guidance.
for Measurement of
Magnetically Induced Torque
on Medical Devices in the
Magnetic Resonance
Environment.

[[Page 50118]]

8-130..................... 8-217..................... ASTM F620-11 Standard Withdrawn and replaced
Specification for Titanium with newer version.
Alloy Forgings for Surgical
Implants in the Alpha Plus
Beta Condition.
8-131..................... 8-218..................... ASTM F799-11 Standard Withdrawn and replaced
Specification for Cobalt- with newer version.
28Chromium-6Molybdenum Alloy
Forgings for Surgical
Implants (UNS R31537, R31538,
R31539).
8-164..................... 8-219..................... ASTM F136-11 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Titanium-6Aluminum-4Vanadium
ELI (Extra Low Interstitial)
Alloy for Surgical Implant
Applications (UNS R56401).
8-174..................... 8-220..................... ASTM F629-11 Standard Practice Withdrawn and replaced
for Radiography of Cast with newer version.
Metallic Surgical Implants.
8-180..................... 8-221..................... ASTM F2066-11 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Titanium-15 Molybdenum Alloy
for Surgical Implant
Applications (UNS R58150).
8-182..................... 8-222..................... ASTM F1537-11 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Cobalt-28Chromium-6Molybdenum
Alloys for Surgical Implants
(UNS R31537, UNS R31538, and
UNS R31539).
8-186..................... 8-223..................... ASTM F2759-11 Standard Guide Withdrawn and replaced
for Assessment of the Ultra with newer version.
High Molecular Weight
Polyethylene (UHMWPE) Used in
Orthopedic and Spinal Devices.
8-210..................... 8-227..................... ASTM F2182-11a Standard Test Withdrawn and replaced
Method for Measurement of with newer version.
Radio Frequency Induced
Heating On or Near Passive
Implants During Magnetic
Resonance Imaging.
----------------------------------------------------------------------------------------------------------------
G. Orthopedics
----------------------------------------------------------------------------------------------------------------
11-175.................... .......................... ASTM F1582-98 (Reapproved Reaffirmation.
2011) Standard Terminology
Relating to Spinal Implants.
11-185.................... .......................... ASTM F2267-04 (Reapproved Reaffirmation.
2011) Standard Test Method
for Measuring Load Induced
Subsidence of Intervertebral
Body Fusion Device Under
Static Axial Compression.
11-186.................... 11-235.................... ASTM F2077-11 Test Methods For Withdrawn and replaced
Intervertebral Body Fusion with newer version.
Devices.
11-195.................... .......................... ASTM F1612-95 (2005), Standard Withdrawn. See 11-225.
Practice for Cyclic Fatigue
Testing of Metallic Stemmed
Hip Arthroplasty Femoral
Components with Torsion.
11-203.................... .......................... ASTM F1541-02 (Reapproved Reaffirmation and
2011) Standard Specification contact person.
and Test Methods for External
Skeletal Fixation Devices.
11-220.................... .......................... ASTM F2068-09, Standard Extent of recognition
Specification for Femoral and CFR citations.
Prostheses--Metallic Implants.
11-230.................... 11-236.................... ASTM F1717-11a Standard Test Withdrawn and replaced
Methods for Spinal Implant with newer version.
Constructs in a Vertebrectomy
Model.
----------------------------------------------------------------------------------------------------------------
H. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-172.................... .......................... ANSI/RESNA WC/Volume 1--1998, Duplicate. See 16-188.
Section 5: Determination of
Overall Dimensions, Mass, and
Turning Space--Wheelchair.
16-186.................... 16-189.................... ASME A18.1-2011 (Revision of Withdrawn and replaced
ASME A18.1-2008) Safety with newer version.
Standard for Platform Lifts
and Stairway Chairlifts.
----------------------------------------------------------------------------------------------------------------
I. Radiology
----------------------------------------------------------------------------------------------------------------
12-102.................... .......................... ANSI/IESNA RP-27.2-00 CFR citation and product
Recommended Practice for codes, devices
Photobiological Safety for affected, processes
Lamps & Lamp Systems-- impacted, and contact
Measurement Techniques. person.
12-153.................... .......................... ANSI/IESNA RP-27.1-05 CFR citation and product
Recommended Practice for codes, devices
Photobiological Safety for affected, processes
Lamps and Lamp Systems-- impacted, and contact
General Requirements. person.
12-179.................... .......................... ANSI/IESNA RP-27.3-07 Extent of recognition,
Recommended Practice for CFR citation and
Photobiological Safety for product codes, devices
Lamps--Risk Group affected, processes
Classification and Labeling. impacted, type of
standard, contact
person, and relevant
guidance.
----------------------------------------------------------------------------------------------------------------
J. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-8...................... .......................... IEC 62304 First edition 2006- Extent of recognition.
05 Medical device software--
Software life cycle processes.
----------------------------------------------------------------------------------------------------------------

[[Page 50119]]

K. Sterility
----------------------------------------------------------------------------------------------------------------
14-55..................... 14-358.................... ANSI/AAMI/ISO 14160:2011 Withdrawn and replaced
Sterilization of health care with newer version.
products--Liquid chemical
sterilizing agents for single-
use medical devices utilizing
animal tissues and their
derivatives--Requirements for
characterization,
development, validation and
routine control of a
sterilization process for
medical devices.
14-123.................... 14-359.................... ASTM F2096-11 Standard Test Withdrawn and replaced
Method for Detecting Gross with newer version.
Leaks in Packaging by
Internal Pressurization
(Bubble Test).
14-227.................... .......................... ANSI/AAMI/ISO 11737-1:2006 (R) Reaffirmation and
2011, Sterilization of health contact person.
care products--
Microbiological methods--Part
1: Determination of the
population of microorganisms
on product.
14-229.................... .......................... ASTM F1980-07 (Reapproved Reaffirmation.
2011) Standard Guide for
Accelerated Aging of Sterile
Barrier Systems for Medical
Devices.
14-264.................... .......................... AAMI/ANSI ST8:2008, Hospital Contact person.
steam sterilizers.
14-277.................... .......................... ISO TS 17665-2:2009, Extent of recognition
Sterilization of health care and contact person.
products--Moist heat--Part 2:
Guidance on the application
of ISO 17665-1.
14-292.................... 14-360.................... ANSI/AAMI ST72:2011 Bacterial Withdrawn and replaced
endotoxins--Test methods, with newer version.
routine monitoring, and
alternatives to batch testing.
14-311.................... .......................... AAMI/ANSI ST55:2010, Table-top Contact person.
steam sterilizers.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

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: 029.

Table 3--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-86.................. Respiratory tract ISO 8185 Third
humidifiers for medical edition 2007-07-01.
use--Particular
requirements for
respiratory
humidification systems.
1-87.................. Medical electrical 60601-2-23 Edition
equipment--Part 2-23: 3.0 2011-02.
Particular requirements
for the basic safety and
essential performance of
transcutaneous partial
pressure monitoring
equipment.
1-88.................. Medical electrical ISO 80601-2-12 First
equipment--Part 2-12: edition 2011-04-15.
Particular requirements
for basic safety and
essential performance of
critical care ventilators.
1-89.................. Medical electrical ISO 80601-2-12:2011
equipment--Part 2-12: TECHNICAL
Particular requirements CORRIGENDUM 1.
for basic safety and
essential performance of
critical care ventilators.
------------------------------------------------------------------------
B. Cardiovascular
------------------------------------------------------------------------
3-101................. Medical electrical ANSI/AAMI/IEC 60601-
equipment--Part 2-27: 2-27:2011.
Particular requirements
for the basic safety and
essential performance of
electrocardiographic
monitoring equipment.
3-103................. Cardiovascular implants-- ISO 25539-3 First
Endovascular devices-- edition 2011-12-01.
Part 3: Vena cava filters.
3-104................. Standard Guide for ASTM F2914-12.
Identification of Shelf-
life Test Attributes for
Endovascular Devices.
------------------------------------------------------------------------
C. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-277................. Prefilled syringes--Part ISO 11040-4 Second
4: Glass barrels for edition 2007-02-01.
injectables.
6-278................. Prefilled syringes--Part ISO 11040-5 Third
5: Plunger stoppers for edition 2012-01-15.
injectables.
6-279................. Medical electrical IEC 60601-2-19
equipment--Part 2-19: (Second edition--
Particular requirements 2009).
for the basic safety and
essential performance of
infant incubators
CORRIGENDUM 1.
6-280................. Medical electrical IEC 60601-2-20
equipment--Part 2-20: (Second edition--
Particular requirements 2009).
for the basic safety and
essential performance of
infant transport
incubators CORRIGENDUM 1.
6-281................. Medical electrical IEC 80601-2-35
equipment--Part 2-35: (Second edition--
Particular requirements 2009).
for the basic safety and
essential performance of
heating devices using
blankets, pads or
mattresses and intended
for heating in medical
use CORRIGENDUM 1.
------------------------------------------------------------------------
D. Materials
------------------------------------------------------------------------
8-224................. Standard Guide for ASTM F2102--06
Evaluating the Extent of [euro]\1\.
Oxidation in Ultra-High-
Molecular-Weight
Polyethylene Fabricated
Forms Intended for
Surgical Implants.

[[Page 50120]]

8-225................. Standard Practice for ASTM F2003--02
Accelerated Aging of (Reapproved 2008).
Ultra-High Molecular
Weight Polyethylene after
Gamma Irradiation in Air.
8-226................. Standard Specification for ASTM F603--12.
High-Purity Dense
Aluminum Oxide for
Medical Application.
------------------------------------------------------------------------
E. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-75.................. Optics and Optical ISO 8600-3 First
instruments--Medical edition 1997-07-01.
endoscopes and endoscopic
accessories--Part 3:
Determination of field of
view and direction of
view of endoscopes with
optics.
9-76.................. Water for haemodialysis ISO 13959 Second
and related therapies. edition 2009-04-15.
9-77.................. Guidance for the ISO 23500 First
preparation and quality edition 2011-05-15.
management of fluids for
haemodialysis and related
therapies.
9-78.................. Quality of dialysis fluid ISO 11663 First
for haemodialysis and edition 2009-04-15.
related therapies.
------------------------------------------------------------------------
F. Ophthalmic
------------------------------------------------------------------------
10-73................. American National Standard ANSI Z80.21-2010.
for Ophthalmics--
Instruments--General-
Purpose Clinical Visual
Acuity Charts.
10-74................. Ophthalmic instruments-- ISO 10940 Second
Fundus cameras. edition 2009-08-01.
------------------------------------------------------------------------
G. Orthopedic
------------------------------------------------------------------------
11-237................ Implants for surgery-- ISO 7206-6 First
Partial and total hip edition 1992-03-l5.
joint prostheses--Part 6:
Determination of
endurance properties of
head and neck region of
stemmed femoral
components.
11-238................ Standard Specification for ASTM F 2033-12.
Total Hip Joint
Prosthesis and Hip
Endoprosthesis Bearing
Surfaces Made of
Metallic, Ceramic, and
Polymeric Materials.
11-239................ Standard Test Methods for ASTM F2345-03
Determination of Static (Reapproved 2008).
and Cyclic Fatigue
Strength of Ceramic
Modular Femoral Heads.
11-240................ Standard Specification and ASTM F382-99
Test Method for Metallic (Reapproved 2008).
Bone Plates.
11-241................ Standard Specification and ASTM F543-07
Test Methods for Metallic [euro]\1\.
Medical Bone Screws.
11-242................ Standard Specification for ASTM F1839-08
Rigid Polyurethane Foam [euro]\2\.
for Use as a Standard
Material for Testing
Orthopaedic Devices and
Instruments.
11-243................ Standard Test Methods for ASTM F2346-05
Static and Dynamic (Reapproved 2011).
Characterization of
Spinal Artificial Discs.
------------------------------------------------------------------------
H. Radiology
------------------------------------------------------------------------
12-249................ Photobiological safety of IEC 62471 First
lamps and lamp systems. edition 2006-07.
------------------------------------------------------------------------
I. Software/Informatics
------------------------------------------------------------------------
13-31................. Specimen Labels: Content CLSI AUTO12-A.
and Location, Fonts, and
Label Orientation;
Approved Standard.
13-32................. Medical device software-- ANSI/AAMI/IEC
Software life cycle 62304:2006.
processes.
------------------------------------------------------------------------
J. Sterility
------------------------------------------------------------------------
14-361................ Sterilization of health ISO 14160 Second
care products--Liquid edition 2011-07-01.
chemical sterilizing
agents for single-use
medical devices utilizing
animal tissues and their
derivatives--Requirements
for characterization,
development, validation
and routine control of a
sterilization process for
medical devices.
------------------------------------------------------------------------
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

[[Page 50121]]

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