Food and Drug Administration Modernization Act of 1997; Modifications to the List of Recognized Standards, Recognition List Number: 012, 30756-30761 [05-10626]
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[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)] [Notices] [Pages 30756-30761] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 05-10626] ----------------------------------------------------------------------- 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: 012 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: 012'' (Recognition List Number: 012), 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 on a 3.5'' diskette of ``Modifications to the List of Recognized Standards, Recognition List Number: 012'' 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.fda.gov/cdrh/ fedregin.html. 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: 012 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, 12720 Twinbrook Pkwy., MD 20857, 301-827-0021. 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 will implement its standard recognition program and provided the initial list of FDA recognized consensus standards. In Federal Register notices published on 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), and October 4, 2004 (69 FR 59240), FDA modified its initial list of FDA recognized consensus standards. These notices described 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 at https://www.fda.gov/cdrh/stdsprog.html. 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 Recognition List Number: 012 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: 012'' to identify these current modifications. In table 1 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 1. ------------------------------------------------------------------------ Old Item Replacement No. Standard Change Item No. ------------------------------------------------------------------------ A. Anesthesia ------------------------------------------------------------------------ 3 ASTM F1161-88, Standard Contact .............. Specification for Minimum person Performance and Safety Requirements for Components and Systems of Anesthesia Gas Machines ------------------------------------------------------------------------ 4 ASTM F1242-96, Standard Withdrawn .............. Specification for Cuffed and Uncuffed Tracheal Tubes ------------------------------------------------------------------------ 7 ASTM F1627-95, Standard Withdrawn .............. Specification for Pediatric Tracheostomy Tubes ------------------------------------------------------------------------ [[Page 30757]] 9 IEC 60601-2-12 (2001-10), Medical Withdrawn 60 Electrical Equipment--Part 2-12: and Particular Requirements for the replaced Safety of Lung Ventilators-- with newer Critical Care Ventilators version ------------------------------------------------------------------------ 15 ISO 5361-4: 1987, Tracheal Tubes-- Contact .............. Part 4: Cole Type person ------------------------------------------------------------------------ 18 ISO 8359: 1996, Oxygen Contact .............. Concentrators for Medical Use-- person Safety Requirements ------------------------------------------------------------------------ 19 ISO 8382: 1988, Resuscitators Contact .............. Intended for Use With Humans person ------------------------------------------------------------------------ 20 ISO 9703-1: 1992, Anesthesia and Withdrawn .............. Respiratory Care Alarm Signals-- Part 1: Visual Alarm Signals ------------------------------------------------------------------------ 21 ISO 9703-2: 1994, Anesthesia and Withdrawn .............. Respiratory Care Alarm Signals-- Part 2: Auditory Alarm Signals ------------------------------------------------------------------------ 30 IEC 60601-2-13 (2003-05), Medical Withdrawn 61 Electrical Equipment--Part 2-13: and Particular Requirements for the replaced Safety and Essential Performance with newer of Anesthetic Systems version ------------------------------------------------------------------------ 31 ISO 5356-1: 2004, Anaesthetic and Withdrawn 62 Respiratory Equipment--Conical and Connectors--Part 1: Cones and replaced Sockets with newer version ------------------------------------------------------------------------ 35 ISO 5361: 1999, Anaesthetic and Contact .............. Respiratory Equipment--Tracheal person Tubes and Connectors ------------------------------------------------------------------------ 38 CGA V-1: 2003, Standard for Withdrawn 63 Compressed Gas Cylinder Valve and Outlet and Inlet Connections replaced with newer version ------------------------------------------------------------------------ 42 ISO 5360: 1993, Anaesthetic Contact .............. Vaporizers--Agent Specific person Filling Systems ------------------------------------------------------------------------ 44 ISO 5366-1: 2000, Anaesthetic and Contact .............. Respiratory Equipment-- person and Tracheostomy Tubes--Part 1: type of Tubes and Connectors for Use in standard Adults ------------------------------------------------------------------------ 50 ASTM F920-93 (1999), Standard Contact .............. Specification for Minimum person Performance and Safety Requirements for Resuscitators Intended for Use With Humans ------------------------------------------------------------------------ 52 ASTM F1463-93 (1999), Standard Contact .............. Specification for Alarm Signals person in Medical Equipment Used in Anesthesia and Respiratory Care ------------------------------------------------------------------------ 53 ASTM F1464-93 (1999), Standard Contact .............. Specification for Oxygen person Concentrators for Domiciliary Use ------------------------------------------------------------------------ 54 ASME PVHO-1-2002-2003, Safety Withdrawn 64 Standard for Pressure Vessels and for Human Occupancy replaced with newer version ------------------------------------------------------------------------ 55 ASTM F1054-01, Standard Contact .............. Specification for Conical person Fittings ------------------------------------------------------------------------ 57 ASTM F1101-90 (2003)e1, Standard Contact .............. Specification for Ventilators person Intended for Use During Anesthesia ------------------------------------------------------------------------ 59 ASTM F1456-01, Standard Contact .............. Specification for Minimum person Performance and Safety Requirements for Capnometers ������������������������������������������������������������������������ B. Cardiovascular/Neurology ------------------------------------------------------------------------ 3 AAMI NS28: 1988/(R)1993, Contact .............. Intracranial Pressure Monitoring person ------------------------------------------------------------------------ 18 IEC 60601-2-27 (1994), Medical Contact .............. Electrical Equipment--Part 2: person and Particular Requirements for the processes Safety of Electrocardiographic affected Monitoring Equipment ------------------------------------------------------------------------ 43 ANSI/AAMI EC38: 1998, Ambulatory Contact .............. Electrocardiographs person, processes affected and extent of recognitio n ������������������������������������������������������������������������ C. Dental/Ear, Nose, and Throat ------------------------------------------------------------------------ 61 ISO 1562: 1993, Dental Casting Contact .............. Gold Alloys person ------------------------------------------------------------------------ 116 ISO 10139-1: 1991, Dentistry-- Date of .............. Resilient Lining Materials for standard Removable Dentures--Part 1: Short-Term Materials ������������������������������������������������������������������������ D. General Hospital/General Plastic Surgery ------------------------------------------------------------------------ [[Page 30758]] 1 AAMI BF7: (R2002), Blood Withdrawn 119 Transfusion Micro-Filters and replaced with newer version ------------------------------------------------------------------------ 29 IEC 60601-2-19 1996-10, Title .............. ``Amendment 1''--Medical Electrical Equipment--Part 2: Particular Requirements for Safety of Baby Incubators ------------------------------------------------------------------------ 32 IEC 60601-2-20 1996-10, Title .............. ``Amendment 1''--Medical Electrical Equipment--Part 2: Particular Requirements for the Safety of Transport Incubators ------------------------------------------------------------------------ 37 ASTM F1054-01, Standard Withdrawn 120 Specification for Conical and Fittings replaced with newer version ------------------------------------------------------------------------ 63 ISO 8536-7-1999, Infusion Title .............. Equipment for Medical Use--Part 7: Caps Made of Aluminum- Plastics Combinations for Infusion Bottles ------------------------------------------------------------------------ 65 ISO 8536-2-2001, Infusion Withdrawn 121 Equipment for Medical Use--Part and 2: Closures for Infusion Bottles replaced with newer version ------------------------------------------------------------------------ 67 ISO 8536-5-2004, Infusion Withdrawn 122 Equipment for Medical Use--Part and 5: Burette Type Infusion Sets replaced for Single Use, Gravity Feed with newer version ------------------------------------------------------------------------ 71 ASTM E667-03, Standard Withdrawn 123 Specification for Mercury-in- and Glass, Maximum Self-Registering replaced Clinical Thermometers with newer version ------------------------------------------------------------------------ 73 ASTM E1104-03, Standard Withdrawn 124 Specification for Clinical and Thermometer Probe Covers and replaced Sheaths with newer version ------------------------------------------------------------------------ 74 ASTM E1965-03, Standard Withdrawn 125 Specification for Infrared and Thermometers for Intermittent replaced Determination of Patient with newer Temperature version ------------------------------------------------------------------------ 75 ISO 8536-4-2004, Infusion Withdrawn 126 Equipment for Medical Use--Part and 4: Infusion Sets for Single Use, replaced Gravity Feed with newer version ------------------------------------------------------------------------ 76 ISO 1135-4-2004, Transfusion Withdrawn 127 Equipment for Medical Use--Part and 4: Transfusion Sets for Single replaced Use with newer version ------------------------------------------------------------------------ 78 ASTM F1670-03, Standard Test Withdrawn 128 Method for Resistance of and Materials Used in Protective replaced Clothing to Penetration by with newer Synthetic Blood version ------------------------------------------------------------------------ 79 ISO 594/2-1998, Conical Fittings Withdrawn 129 With a 6% (Luer) Taper for and Syringes, Needles and Certain replaced Other Medical Equipment--Part 2: with newer Lock Fittings version ������������������������������������������������������������������������ E. Materials ------------------------------------------------------------------------ 36 ASTM F1801-97 (2004), Standard Withdrawn 103 Practice for Corrosion Fatigue and Testing of Metallic Implant replaced Materials with newer version ------------------------------------------------------------------------ 51 ASTM F1108-04, Standard Withdrawn 104 Specification for Titanium- and 6Aluminum-4Vanadium Alloy replaced Castings for Surgical Implants with newer (UNS R56406) version ------------------------------------------------------------------------ 69 Title: ISO 5832-10: 1996, Withdrawn .............. Implants for Surgery--Metallic Materials--Part 10: Wrought Titanium 5-Aluminum 2,5-Iron ------------------------------------------------------------------------ 70 Title: ASTM F2052-02, Standard Error in 70 Test Method for Measurement of October 4, Magnetically Induced 2004 Displacement Force on Medical Federal Devices in the Magnetic Register Resonance Environment Notice (69 FR 59240) (Recogniti on List Number: 011) [Docket No. 2004N- 0226]--not withdrawn ------------------------------------------------------------------------ 96 ASTM F1635-04(a), Standard Test Withdrawn 105 Method for In Vitro Degradation and Testing of Hydrolytically replaced Degradable Polymer Resins and with newer Fabricated Forms for Surgical version Implants ������������������������������������������������������������������������ F. Ophthalmic ------------------------------------------------------------------------ 5 ISO 9363-1: 1994, Optics and Withdrawn .............. Optical Instruments--Contact Lenses--Determination of Cytotoxicity of Contact Lens Material--Part 1: Agar Overlay Test and Growth Inhibition Test ------------------------------------------------------------------------ [[Page 30759]] 14 ANSI Z80.20-2004, Ophthalmics-- Withdrawn 34 Contact Lenses--Standard and Terminology, Tolerances, replaced Measurements and Physicochemical with newer Properties version ------------------------------------------------------------------------ 15 ISO 9394:1998, Ophthalmic Optics-- Title .............. Contact Lenses and Contact Lens Care Products--Determination of Biocompatibility by Ocular Study Using Rabbit Eyes ------------------------------------------------------------------------ 30 ANSI Z80.7-2002, Ophthalmics-- Title .............. Intraocular Lenses ������������������������������������������������������������������������ G. Radiology ------------------------------------------------------------------------ 1 ANSI PH 2.43-1982, Method for Title .............. Sensitometry/Medical X-Ray Screen-Film ------------------------------------------------------------------------ 5 ANSI PH 2.50-1983, Method/ Title .............. Sensitometry Direct-Exposure Medical/Dental ------------------------------------------------------------------------ 7 IEC/ISO 10918-1: 1994, Title .............. Information Technology--Digital Compression and Coding of Continuous-Tone Still Images-- Part 1: Requirements and Guidelines ------------------------------------------------------------------------ 8 IEC 60336 (R1993), X-Ray Tube Title and .............. Assemblies for Medical standards Diagnosis--Characteristics of developmen Focal Spots t organizati on ------------------------------------------------------------------------ 14 NEMA MS 5-2003, Determination of Withdrawn 125 Slice Thickness in Diagnostic and Magnetic Resonance Imaging replaced with newer version ------------------------------------------------------------------------ 22 IEC NEMA XR5-1992 (R1999), Withdrawn .............. Measurement of Dimensions and Properties of Focal Spots of Diagnostic X-Ray Tubes ------------------------------------------------------------------------ 23 NEMA XR 10-1986 (R1992, R1998), Contact .............. Measurement of the Maximum person, Symmetrical Radiation Field From title, and a Rotating Anode X-Ray Tube Used standards for Medical Diagnosis developmen t organizati on ------------------------------------------------------------------------ 33 IEC 60601-2-1: 1998, Medical Withdrawn .............. Electrical Equipment--Part 2: Particular Requirements for Medical Electron Accelerators in the Range 1 MeV to 50 MeV ------------------------------------------------------------------------ 36 IEC 60601-2-9 (1996-10), Medical Title .............. Electrical Equipment--Part 2: Particular Requirements for the Safety of Patient Contact Dosimeters Used in Radiotherapy With Electrically Connected Radiation Detectors--ed. 2.0 ------------------------------------------------------------------------ 40 IEC 60601-2-28: 2003, Medical Withdrawn 126 Electrical Equipment--Part 2: and Particular Requirements for the replaced Safety of X-Ray Source with newer Assemblies and X-Ray Tube version Assemblies for Medical Diagnosis--ed. 1.0 ------------------------------------------------------------------------ 42 IEC 60601-2-32: 2003, Medical Withdrawn 127 Electrical Equipment--Part 2: and Particular Requirements for the replaced Safety of Associated Equipment with newer of X-Ray Equipment--ed. 1.0 version ------------------------------------------------------------------------ 50 IEEE N42.13-1993, Calibration and Withdrawn 128 Usage of ``Dose Calibrator'' and Ionization Chambers for the replaced Assay of Radionuclides with newer version ------------------------------------------------------------------------ 52 UL 544 (1998), Standard for Title .............. Medical and Dental Equipment-- ed. 4.0 ------------------------------------------------------------------------ 58 ANSI N43.6-1997, Sealed Title and .............. Radioactive Sources, standards Classification developmen t organizati on ------------------------------------------------------------------------ 61 UL 122 (1999), Standard for Title .............. Photographic Equipment--ed. 4.0 ------------------------------------------------------------------------ 62 UL 187 (1998), Standard for X-Ray Title .............. Equipment--ed. 7.0 ------------------------------------------------------------------------ 74 NEMA MS 7-1998, Measurement Withdrawn .............. Procedure for Time-Varying Gradient Fields (dB/dt) for Magnetic Resonance Imaging Systems ------------------------------------------------------------------------ 75 NEMA NU 1-2004, Performance Withdrawn 129 Measurements of Scintillation and Cameras replaced with newer version ------------------------------------------------------------------------ 83 IEC 60601-2-37 2004, Medical Withdrawn 130 Electrical Equipment--Part 2-37: and Particular Requirements for the replaced Safety of Ultrasonic Medical with newer Diagnostic and Monitoring version Equipment Consolidated, ed. 1.1 ------------------------------------------------------------------------ 87 IEC 61217 2003, Radiotherapy Withdrawn 131 Equipment--Coordinates, and Movements and Scales replaced Consolidated, ed. 1.1 with newer version ------------------------------------------------------------------------ [[Page 30760]] 90 IEC 60601-2-1 (1998-06), Medical Title .............. Electrical Equipment--Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV ------------------------------------------------------------------------ 91 IEC 60601-2-8 (1997-08), Title .............. Amendment 1--Medical Electrical Equipment--Part 2: Particular Requirements for the Safety of Therapeutic X-Ray Equipment Operating in the Range 10 kV to 1 MV ------------------------------------------------------------------------ 98 IEC 60731 (2002-06), Amendment 1-- Withdrawn 132 Medical Electrical Equipment-- and Dosimeters With Ionization replaced Chambers as Used in Radiotherapy with newer version ------------------------------------------------------------------------ 120 IEC 60601-2-44 (2002-11), Medical Title .............. Electrical Equipment--Part 2-44: Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography--ed. 2.1 ������������������������������������������������������������������������ H. Sterility ------------------------------------------------------------------------ 121 ASTM D4169-04a, Standard Practice Extent of .............. for Performance Testing of recognitio Shipping Containers and Systems n ------------------------------------------------------------------------ 123 ASTM F2096-04, Standard Test Title .............. Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) ------------------------------------------------------------------------ 135 ANSI/AAMI ST63: 2002, Title .............. Sterilization of Health Care Products--Requirements for the Development, Validation and Routine Control of an Industrial Sterilization Process for Medical Devices--Dry Heat ------------------------------------------------------------------------ III. Listing of New Entries The listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 012, follows: Table 2. ------------------------------------------------------------------------ Reference No. Item No. Title of Standard and Date ------------------------------------------------------------------------ A. General Hospital/General Plastic Surgery ------------------------------------------------------------------------ 114 Pen-Injectors for Medical Use--Part 1: ISO 11608-1: Pen-Injectors--Requirements and Test 2000 Methods ------------------------------------------------------------------------ 115 Pen-Injectors for Medical Use--Part 2: ISO 11608-2: Needles--Requirements and Test Methods 2000 ------------------------------------------------------------------------ 116 Pen-Injectors for Medical Use--Part 3: ISO 11608-3: Finished Cartridges--Requirements and 2000 Test Methods ------------------------------------------------------------------------ 117 Standard Specification for Blood/ ASTM F2172-02 Intravenous Fluid/Irrigation Fluid Warmers ------------------------------------------------------------------------ 118 Standard Specification for Circulating ASTM F2196-02 Liquid and Forced Air Patient Temperature Management Devices ������������������������������������������������������������������������ B. Radiology ------------------------------------------------------------------------ 121 Ultrasonics--Surgical Systems-- IEC 61847: 1998 Measurement and Declaration of the Basic Output Characteristics, ed. 1.0 ------------------------------------------------------------------------ 122 Medical Electrical Equipment-- IEC 62083: 2000 Requirements for the Safety of Radiotherapy Treatment Planning Systems, ed. 1.0 ------------------------------------------------------------------------ 123 Ultrasonics--Physiotherapy Systems-- IEC 61689: 1996 Performance Requirements and Methods of Measurement in the Frequency Range 0.5 MHz to 5 MHz, ed. 1.0 ������������������������������������������������������������������������ C. Sterility ------------------------------------------------------------------------ 144 Standard Test Method for Linear ASTM F2203-02e1 Measurement Using Precision Steel Rule ------------------------------------------------------------------------ 145 Standard Practice for Coating/Adhesive ASTM F2217-02 Weight Determination ------------------------------------------------------------------------ 146 Standard Test Method of Leaks in Non- ASTM F2227-02 Sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method ------------------------------------------------------------------------ 147 Standard Test Method for Non-Destructive ASTM F2228-02 Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method ------------------------------------------------------------------------ [[Page 30761]] 148 Standard Practice for Evaluation of ASTM F2250-03 Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials ------------------------------------------------------------------------ 149 Standard Test Method for Thickness ASTM F2251-03e1 Measurement of Flexible Packaging Materials ------------------------------------------------------------------------ 150 Standard Practice for Evaluating Ink or ASTM F2252-03 Coating Adhesion to Flexible Packaging Materials Using Tape ------------------------------------------------------------------------ 151 Standard Test Method for Nondestructive ASTM F2338-04 Detection of Leaks in Packages by Vacuum Decay Method ------------------------------------------------------------------------ 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 document into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT). To be properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access In order to receive ``Guidance on the Recognition and Use of Consensus Standards'' via your fax machine, call the Center for Devices and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number 321 followed by the pound sign. Follow the remaining voice prompts to complete your request. You may also obtain a copy of ``Guidance on the Recognition and Use of Consensus Standards'' by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this document announcing ``Modification to the List of Recognized Standards, Recognition List Number: 012'' 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.fda.gov/ cdrh/fedregin.html. VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 012. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register. Dated: May 16, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05-10626 Filed 5-26-05; 8:45 am] BILLING CODE 4160-01-S
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