Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 019, 71924-71930 [E7-24580]
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[Federal Register Volume 72, Number 243 (Wednesday, December 19, 2007)] [Notices] [Pages 71924-71930] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: E7-24580] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0226] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 019 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: 019'' (Recognition List Number: 019), 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: 019'' to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. 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.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfTopic/cdrhnew.cfm. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 019 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0533. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled ``Recognition and Use of Consensus Standards.'' The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the Federal Register, are identified in table 1 of this document. Table 1 ------------------------------------------------------------------------ Federal Register Cite ------------------------------------------------------------------------- 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) ------------------------------------------------------------------------ These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains ``hypertext markup [[Page 71925]] 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: 019 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: 019 to identify these current modifications. In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA. Table 2. ------------------------------------------------------------------------ Old Item Replacement No. Standard Change Item No. ------------------------------------------------------------------------ A. Anesthesia ------------------------------------------------------------------------ 11 IEC 60601-3-1:1996-08 Medical Title Change .............. Electrical Equipment - Part Contact person 3-1: Essential Performance Requirement for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring Equipment ------------------------------------------------------------------------ 18 ISO 8359:1996 Oxygen Contact person .............. Concentrators for Medical Use - Safety Requirements ------------------------------------------------------------------------ 51 ASTM F1100-90(1997) Standard Contact person .............. Specification for Relevant Ventilators Intended for Use guidance in Critical Care ------------------------------------------------------------------------ 57 ASTM F1101-90(2003)e1 Contact person .............. Standard Specification for Ventilators Intended for Use During Anesthesia ------------------------------------------------------------------------ 59 ASTM F1456-01 Standard Relevant .............. Specification for Minimum guidance Performance and Safety Requirements for Capnometers ------------------------------------------------------------------------ 60 IEC 60601-2-12:(2001-10) Contact person .............. Medical Electrical Equipment Relevant - Part 2-12: Particular guidance Requirements for the Safety of Lung Ventilators - Critical Care Ventilators ------------------------------------------------------------------------ 61 IEC 60601-2-13(2003-05):, Relevant .............. Medical electrical equipment guidance - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems ------------------------------------------------------------------------ 65 ISO 21647: 2004 Medical Title Change .............. Electrical Equipment - Relevant Particular Requirements for guidance the Basic Safety and Essential Performance of Respiratory Gas Monitors ------------------------------------------------------------------------ 69 ASTM F1464-93(2005) Standard Contact person .............. Specification for Oxygen Concentrators for Domiciliary Use ------------------------------------------------------------------------ 70 ASTM F 1246-91 (2005) Contact person .............. Standard Specification for Relevant Electrically Powered Home guidance Care Ventilators, Part 1 - Positive-Pressure Ventilators and Ventilator Circuits ------------------------------------------------------------------------ 71 ISO 10651-5:2006 Lung Contact person .............. Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas- powered Emergency Resuscitators ------------------------------------------------------------------------ B. General ------------------------------------------------------------------------ 20 ASTM F1140:1988: Standard Withdrawn .............. Test Method for Failure Resistance of Unrestrained and Nonrigid Packages for Medical Applications ------------------------------------------------------------------------ C. General Hospital/General Plastic Surgery ------------------------------------------------------------------------ 21 ISO 10555-3: 1996 Sterile, Withdrawn 171 Single-use Intravascular duplicate Catheters - Part 3: Central Venous Catheters ------------------------------------------------------------------------ 81 ASTM E1061-01(2007) Standard Withdrawn and 200 Specification for Direct- replaced with Reading Liquid Crystal newer version Forehead Thermometers ------------------------------------------------------------------------ [[Page 71926]] 111 IEC 60601-2-38: 1996 Medical Withdrawn 182 Electrical Equipment - Part duplicate 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds ------------------------------------------------------------------------ 117 ASTM F2172-02:, Standard Contact person .............. Specification for Blood/ Intravenous Fluid/Irrigation Fluid Warmers ------------------------------------------------------------------------ 121 ISO 8536-2-2001 Infusion Withdrawn 173 Equipment for Medical Use - duplicate Part 2: Closures for Infusion Bottles ------------------------------------------------------------------------ 126 ISO 8536-4:2007 Infusion Withdrawn and 201 Equipment for Medical Use -- replaced with Part 4: Infusion Sets for newer version Single-use, Gravity Feed ------------------------------------------------------------------------ 162 ISO 8536-1:2000/Amendment Withdrawn 172 1:2004 Infusion Equipment duplicate for Medical Use - Part 1: Infusion Glass Bottles ------------------------------------------------------------------------ D. In Vitro Diagnostics ------------------------------------------------------------------------ 31 CLSI H20-A2 Reference Withdrawn and 130 Leukocyte (WBC) Differential replaced with Count (Proportional) and newer version Evaluation of Instrumental Methods; Approved Standard-- Second Edition ------------------------------------------------------------------------ E. Materials ------------------------------------------------------------------------ 3 ASTM F90-07 Standard Withdrawn and 145 Specification for Wrought replaced with Cobalt-20 Chromium-15 newer version Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) ------------------------------------------------------------------------ 30 ASTM F1537-07 Standard Withdrawn and 152 Specification for Wrought replaced with Cobalt-28Chromium-6Molybdenu newer version m Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) ------------------------------------------------------------------------ 41 ASTM F2066-07 Standard Withdrawn and 146 Specification for Wrought replaced with Titanium-15 Molybdenum Alloy newer version for Surgical Implant Applications (UNS R58150) ------------------------------------------------------------------------ 42 ASTM F2119-07 Standard Test Withdrawn and 153 Method for Evaluation of MR replaced with Image Artifacts from Passive newer version Implants ------------------------------------------------------------------------ 45 ASTM F562-07 Standard Withdrawn and 147 Specification for Wrought replaced with 35Cobalt-35Nickel-20Chromium newer version -10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) ------------------------------------------------------------------------ 48 ASTM F899-07 Standard Withdrawn and 148 Specification for Stainless replaced with Steel for Surgical newer version Instruments ------------------------------------------------------------------------ 56 ISO 5832-1:2007 Implants for Withdrawn and 149 Surgery -- Metallic replaced with Materials -- Part 1: Wrought newer version Stainless Steel ------------------------------------------------------------------------ 62 ISO 5832-9:2007 Implants for Withdrawn and 150 Surgery - Metallic Materials replaced with - Part 9: Wrought High newer version Nitrogen Stainless Steel ------------------------------------------------------------------------ 64 ISO 5832-12:2007 Implants for Withdrawn and 151 surgery -- Metallic replaced with materials -- Part 12: newer version Wrought cobalt-chromium- molybdenum alloy ------------------------------------------------------------------------ F. OB-GYN/Gastroenterology ------------------------------------------------------------------------ 5 IEC 60601-2-18 (1996) Medical Withdrawn 42 Electrical Equipment - Part duplicate 2: Particular Requirements for the Safety of Endoscopic Equipment ------------------------------------------------------------------------ G. Ophthalmic ------------------------------------------------------------------------ 35 ISO 10939:2007 Ophthalmic Contact person .............. Instruments -- Slit-lamp Microscopes ------------------------------------------------------------------------ 37 ISO 10942:2006 Ophthalmic Contact person .............. Instruments -- Direct ophthalmoscopes ------------------------------------------------------------------------ 38 ISO 10943:2006 Ophthalmic Contact person .............. Instruments -- Indirect ophthalmoscopes ------------------------------------------------------------------------ 39 ISO 12865:2006 Ophthalmic Contact person .............. Instruments -- Retinoscopes ------------------------------------------------------------------------ 51 ISO 15004-2:2007 Ophthalmic Contact person .............. Instruments--Fundamental Requirements and Test Methods Part 2: Light Hazard Protection ------------------------------------------------------------------------ H. Radiology ------------------------------------------------------------------------ [[Page 71927]] 7 IEC / ISO 10918-1:1994 Withdrawn 150 Information Technology-- duplicate Digital Compression and Coding of Continuous-tone Still Images - Part 1: Requirements and Guidelines ------------------------------------------------------------------------ 76 NU 2-2007 Performance Withdrawn and 167 Measurements of Positron replaced with Emission Tomographs newer version ------------------------------------------------------------------------ 84 IEC 60825-1 Ed. 2.0 (2007) Withdrawn and 168 Safety of Laser Products - replaced with Part 1: Equipment newer version Classification and Requirements ------------------------------------------------------------------------ 85 IEC 60601-2-22 Ed. 3.0 (2007) Withdrawn and 169 Medical Electrical Equipment replaced with - Part 2-22: Particular newer version Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment ------------------------------------------------------------------------ 90 IEC 60601-2-1 (1998-06) Withdrawn 152 Medical Electrical Equipment duplicate - Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV ------------------------------------------------------------------------ 102 ANSI / IESNA RP-27.2-2000 Contact person .............. Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques ------------------------------------------------------------------------ 103 ANSI / IESNA RP-27.3-1996 Contact person .............. Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling ------------------------------------------------------------------------ 112 ISO 11670:2003 Lasers and Withdrawn 156 Laser-related Equipment - duplicate Test Methods for Laser Beam Parameters - Beam Positional Stability ------------------------------------------------------------------------ 114 ISO 13694:2000 Optics and Withdrawn 157 Optical Instruments - Lasers duplicate and Laser-related Equipment - Test Methods for Laser Beam Power (energy) Density Distribution ------------------------------------------------------------------------ 119 NEMA PS 3.1 - 3.18 (2007) Withdrawn and 170 Digital Imaging and replaced with Communications in Medicine newer version (DICOM) Set ------------------------------------------------------------------------ 153 ANSI / IESNA RP-27.1-2005 Contact person .............. Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements ------------------------------------------------------------------------ I. Software/Informatics ------------------------------------------------------------------------ 4 ANSI/UL 1998 Software in Relevant .............. Programmable Components guidance ------------------------------------------------------------------------ 5 IEC 60601-3-1:1996-08 Medical Relevant .............. electrical equipment - Part guidance 3-1: Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment ------------------------------------------------------------------------ 8 IEC 62304 Ed. 1.0 Medical Relevant .............. device software - Software guidance life cycle processes ------------------------------------------------------------------------ J. Sterility ------------------------------------------------------------------------ 25 ANSI/AAMI/ISO 11135-1:2007 Withdrawn and 228 Sterilization of Health Care replaced with Products - Ethylene oxide - newer version Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices ------------------------------------------------------------------------ 63 ASTM F1886: 1998 (2004) Relevant .............. Standard Test Method for guidance Determining Integrity of Seals for Medical Packaging by Visual Inspection ------------------------------------------------------------------------ 64 ASTM F1929:1998 (2004) Relevant .............. Standard Test Method for guidance Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration ------------------------------------------------------------------------ 86 ASTM F1980-07 Standard Guide Withdrawn and 229 for Accelerated Aging of replaced with Sterile Barrier Systems for newer version Medical Devices ------------------------------------------------------------------------ 120 ASTM D3078:2002 Standard Test Relevant .............. Method for Determination of guidance Leaks in Flexible Packaging by Bubble Emission ------------------------------------------------------------------------ 136 AAMI/ANSI ST67:2003 Relevant .............. Sterilization of Health Care guidance Products - Requirements for Products Labeled 'Sterile' 1st edition ------------------------------------------------------------------------ 144 ASTM F2203-02(2007) Standard Withdrawn and 230 Test Method for Linear replaced with Measurement Using Precision newer version Steel Rule ------------------------------------------------------------------------ [[Page 71928]] 145 ASTM F2217-02(2007) Standard Withdrawn and 231 Practice for Coating/ replaced with Adhesive Weight newer version Determination ------------------------------------------------------------------------ 146 ASTM F2227-02(2007) Standard Withdrawn and 232 Test Method for Non- replaced with Destructive Detection of newer version Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method ------------------------------------------------------------------------ 147 ASTM F2228-02(2007) Standard Withdrawn and 233 Test Method for Non- replaced with Destructive Detection of newer version Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method ------------------------------------------------------------------------ 167 ASTM F2097-07 Standard Guide Withdrawn and 234 for Design and Evaluation of replaced with Primary Flexible Packaging newer version for Medical Products ------------------------------------------------------------------------ 168 ASTM F2338-05 Standard Test Relevant .............. Method for Nondestructive guidance Detection of Leaks in Packages by Vacuum Decay Method ------------------------------------------------------------------------ 169 ASTM F2391-05 Standard Test Relevant .............. Method for Measuring Package guidance and Seal Integrity Using Helium as Tracer Gas ------------------------------------------------------------------------ 170 ASTM F2475-05 Standard Guide Relevant .............. for Biocompatibility guidance Evaluation of Medical Device Packaging Materials ------------------------------------------------------------------------ 193 AAMI/ANSI/ISO 11607-1:2006 Relevant .............. Packaging for Terminally guidance Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems, 3ed. ------------------------------------------------------------------------ 194 AAMI/ANSI/ISO 11607-2:2006 Relevant .............. Packaging for Terminally guidance Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1ed. ------------------------------------------------------------------------ 196 ASTM F1140-07 Standard Test Withdrawn and 235 Methods for Internal replaced with Pressurization Failure newer version Resistance of Unrestrained Packages ------------------------------------------------------------------------ 197 ASTM F1608:00(2004) Standard Relevant .............. Test Method for Microbial guidance Ranking of Porous Packaging Materials (Exposure Chamber Method) ------------------------------------------------------------------------ 198 ASTM F2054-07 Standard Test Withdrawn and 236 Method for Burst Testing of replaced with Flexible Package Seals Using newer version Internal Air Pressurization Within Restraining Plates ------------------------------------------------------------------------ 199 ASTM D4169-05 Standard Relevant .............. Practice for Performance guidance Testing of Shipping Containers and Systems ------------------------------------------------------------------------ 200 ASTM F88-07 Standard Test Withdrawn and 237 Method for Seal Strength of replaced with Flexible Barrier Materials newer version ------------------------------------------------------------------------ K. Tissue Engineering ------------------------------------------------------------------------ 2 ASTM F2103-01(2007)e1 Withdrawn and 12 Standard Guide for replaced with Characterization and Testing newer version of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications ------------------------------------------------------------------------ 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: 019. Table 3. ------------------------------------------------------------------------ Item No. Title of Standard Reference No. & Date ------------------------------------------------------------------------ A. Anesthesia ------------------------------------------------------------------------ 76 Anaesthetic and Respiratory ISO 26825:2007 Equipment--User-applied Labels for Syringes Containing Drugs Used During Anaesthesia-- Colours, Design and Performance ------------------------------------------------------------------------ B. Dental/ ENT ------------------------------------------------------------------------ [[Page 71929]] 145 Dentistry--Membrane Materials for ISO 22803:2004 Guided Tissue Regeneration in Oral and Maxillofacial Surgery-- Contents of a Technical File ------------------------------------------------------------------------ 146 Dentistry--Metallic Materials for ISO 22674: 2006 Fixed and Removable Restorations and Appliances ------------------------------------------------------------------------ C. General Hospital/ General Plastic Surgery ------------------------------------------------------------------------ 202 Lasers and Laser-related ISO 11810-2:2007 Equipment -- Test Method and Classification for the Laser- resistance of Surgical Drapes and/or Patient-protective Covers -- Part 2: Secondary Ignition ------------------------------------------------------------------------ D. Ophthalmic ------------------------------------------------------------------------ 53 Ophthalmic optics--Contact Lenses ISO 18369-1:2006 -- Part 1: Vocabulary, Classification System and Recommendations for Labeling Specifications ------------------------------------------------------------------------ 54 Ophthalmic Optics- Contact Lenses- ISO 18369-4:2006 Part 4: Physicochemical Properties of Contact Lens Materials ------------------------------------------------------------------------ 55 Ophthalmic implants -- ISO 11979-6:2007 Intraocular Lenses -- Part 6: Shelf-life and Transport Stability ------------------------------------------------------------------------ E. Radiology ------------------------------------------------------------------------ 171 Optics and Photonics -- Microlens ISO 14880-2:2006 Arrays -- Part 2: Test Methods for Wavefront Aberrations ------------------------------------------------------------------------ 172 Optics and Photonics -- Microlens ISO 14880-3:2006 Arrays -- Part 3: Test Methods for Optical Properties Other than Wavefront Aberrations ------------------------------------------------------------------------ 173 Optics and Photonics -- Microlens ISO 14880-4:2006 Arrays -- Part 4: Test Methods for Geometrical Properties ------------------------------------------------------------------------ 174 Optics and Photonics -- Lasers ISO 13697:2006 and Laser-related Equipment -- Test Methods for Specular Reflectance and Regular Transmittance of Optical Laser Components ------------------------------------------------------------------------ 175 Optics and Photonics -- Lasers ISO 24013:2006 and Laser-related Equipment -- Measurement of Phase Retardation of Optical Components for Polarized Laser Radiation ------------------------------------------------------------------------ 176 Evaluation and Routine Testing in IEC 61223-3-2 Ed. 2.0 Medical Imaging Departments - (2007) Part 3-2: Acceptance Tests - Imaging Performance of Mammographic X-ray Equipment ------------------------------------------------------------------------ F. Sterility ------------------------------------------------------------------------ 238 Sterilization of Health Care ANSI/AAMI/ISO11140- Products - Chemical Indicators - 5:2007 Part 5: Class 2 Indicators for Bowie and Dick-type Air Removal Tests ------------------------------------------------------------------------ 239 Aseptic Processing of Health Care ISO 13408-3:2006 Products--Part 3: Lyophilization ------------------------------------------------------------------------ 240 Aseptic Processing of Health Care ISO 13408-5:2006 Products--Part 5: Sterilization- in-place ------------------------------------------------------------------------ 241 Aseptic Processing of Health Care ISO 13408-6:2005 Products--Part 6: Isolator Systems ------------------------------------------------------------------------ 242 Cleanrooms and Associated ISO 14644-3:2005 Controlled Environments--Part 3: Test Methods ------------------------------------------------------------------------ 243 Cleanrooms and Associated ISO 14644-6:2007 Controlled Environments--Part 6: Vocabulary ------------------------------------------------------------------------ 244 Cleanrooms and Associated ISO 14644-8:2006 Controlled Environments - Part 8: Classification of Airborne Molecular Contamination ------------------------------------------------------------------------ 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 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 71930]] the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access You may obtain a copy of ``Guidance on the Recognition and Use of Consensus Standards'' by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this notice announcing ``Modification to the List of Recognized Standards, Recognition List Number: 019'' will be available on the CDRH home page. You may access the CDRH home page at https:// www.fda.gov/cdrh. You may access ``Guidance on the Recognition and Use of Consensus Standards,'' and the searchable database for ``FDA Recognized Consensus Standards'' through the hyperlink at https://www.fda.gov/cdrh/ stdsprog.html. This Federal Register document on modifications in FDA's recognition of consensus standards is available at https:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 019. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register. Dated: December 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-24580 Filed 12-18-07; 8:45 am] BILLING CODE 4160-01-S
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