Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 014, 16313-16317 [E6-4695]
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[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)] [Notices] [Pages 16313-16317] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: E6-4695] ----------------------------------------------------------------------- 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: 014 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: 014'' (Recognition List Number: 014), 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: 014'' 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.hhs.gov. This document may also be accessed on FDA's Web 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: 014 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., Rockville, 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 would implement its standard recognition program and provided the initial list of recognized 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), October 4, 2004 (69 FR 59240), May 27, 2005 (70 FR 30756), and November 8, 2005 (70 FR 67713), FDA modified its initial list of FDA recognized consensus standards. 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 Web 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: 014 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: 014'' 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 Item No. Standard Change No. ------------------------------------------------------------------------ A. Anesthesia ------------------------------------------------------------------------ [[Page 16314]] 32 ISO 7767: 1997: Oxygen Withdrawn ................. Monitors for Monitoring Patient Breathing Mixtures--Safety Requirements ------------------------------------------------------------------------ 33 ISO 9918: 1993: Withdrawn ................. Capnometers for Use with Humans--Requirements ------------------------------------------------------------------------ 41 NFPA 99: 2005: Standard Withdrawn and 67 for Health Care replaced Facilities Chapter 20-- with newer Hyperbaric Facilities version ------------------------------------------------------------------------ B. Dental/Ear, Nose, and Throat ------------------------------------------------------------------------ 52 ANSI/ADA Specification Date ................. No. 27: 1997, Resin- Based Filling Materials ------------------------------------------------------------------------ 60 ANSI/ADA Specification Date and ................. No. 96: 2000, Dental- title Water-Based Cements-- Adoption of ISO 9917: 1991 ------------------------------------------------------------------------ 114 ANSI/ADA Specification Date ................. No. 48: 2004, Ultraviolet Activator and Disclosing Lights ------------------------------------------------------------------------ C. General Hospital/General Plastic Surgery ------------------------------------------------------------------------ 47 ASTM D5712-05 Standard Withdrawn and 144 Test Method for Analysis replaced of Aqueous Extractable with newer Protein in Natural version Rubber and Its Products Using the Modified Lowry Method ------------------------------------------------------------------------ 77 ASTM F1862-00a Standard Contact ................. Test Method for person Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) ------------------------------------------------------------------------ 86 ASTM D3578-05 Standard Withdrawn and 145 Specification for Rubber replaced Examination Gloves with newer version ------------------------------------------------------------------------ 96 ASTM F2101-01 Standard Contact ................. Test Method for person Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus ------------------------------------------------------------------------ 112 AAMI/ANSI PB70: 2003 Contact ................. Liquid barrier person performance and classification of protective apparel and drapes intended for use in health care facilities ------------------------------------------------------------------------ 113 ASTM F2100-04 Standard Contact ................. Specification for person Performance of Materials Used in Medical Face Masks ------------------------------------------------------------------------ 120 ASTM F1054-01 Standard Withdrawn ................. Specification for Conical Fittings ------------------------------------------------------------------------ 128 ASTM F1670-03 Standard Contact ................. Test Method for person Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood ------------------------------------------------------------------------ D. Materials ------------------------------------------------------------------------ 14 ASTM F688-05: Standard Withdrawn and 119 Specification for replaced Wrought Cobalt-35Nickel- with newer 20Chromium-10Molybdenum version Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) ------------------------------------------------------------------------ 38 ASTM F2005-00: Standard Withdrawn ................. Terminology for Nickel- Titanium Shape Memory Alloys ------------------------------------------------------------------------ 78 ASTM F560-05: Standard Withdrawn and 120 Specification for replaced Unalloyed Tantalum for with newer Surgical Implant version Applications (UNS R05200, UNS R05400) ------------------------------------------------------------------------ 100 ASTM F2005-05: Standard Withdrawn and 121 Terminology for Nickel- replaced Titanium Shape Memory with newer Alloys version ------------------------------------------------------------------------ E. OB-GYN/Gastroenterology ------------------------------------------------------------------------ [[Page 16315]] 19 ISO 8600-1: 2005 Optics Withdrawn and 37 and photonics--Medical replaced endoscopes and with newer endotherapy devices-- version Part 1: General requirements ------------------------------------------------------------------------ F. Orthopedic/Physical Medicine ------------------------------------------------------------------------ 162 ASTM F564-02: Standard Extent of ................. Specification and Test recognition, Methods for Metallic type of Bone Staples standard, contact person and related Code of Federal Regulations citation and product codes ------------------------------------------------------------------------ 164 ASTM F1541-02: Standard Devices ................. Specification and Test affected, Methods for External processes Skeletal Fixation affected, Devices extent of recognition, type of standard, and contact person ------------------------------------------------------------------------ 182 ASTM F1800-04: Standard Processes ................. Test Method for Cyclic affected and Fatigue Testing of Metal relevant Tibial Tray Components guidance of Total Knee Joint Replacements ------------------------------------------------------------------------ G. Radiology ------------------------------------------------------------------------ 1 ISO 9236-1: 2004 Withdrawn and 136 Photography--Sensitometr replaced y of screen/film systems with newer for medical radiography-- version Part 1: Determination of sensitometric curve shape, speed and Average Gradient ------------------------------------------------------------------------ 2 ISO 4090: 2001 Withdrawn and 137 Photography--Medical replaced radiographic cassettes/ with newer screens/films and hard- version copy imaging films-- Dimensions and specifications ------------------------------------------------------------------------ 5 ISO 5799: 1991 Withdrawn and 138 Photography--Direct- replaced exposing medical and with newer dental radiographic film/ version process systems-- Determination of ISO Speed and ISO average gradient ------------------------------------------------------------------------ 37 IEC 60601-2-11-2004 Withdrawn and 133 Amendment 1--Medical replaced electrical equipment-- with newer Part 2-11: Particular version requirements for the safety of gamma beam therapy equipment ------------------------------------------------------------------------ 44 AOMS-2005 Acoustic Output Withdrawn and 139 Measurement Standard for replaced Diagnostic Ultrasound with newer Equipment version ------------------------------------------------------------------------ 46 RTD1-2005 Standard for Withdrawn and 140 Real-Time Display of replaced Thermal and Mechanical with newer Acoustic Output Indices version on Diagnostic Ultrasound Equipment Revision 1 ------------------------------------------------------------------------ 101 ANSI/IESNA RP-27.1-1996 Title ................. Recommended Practice for Photobiological Safety for Lamps and Lamp Systems--General Requirements ------------------------------------------------------------------------ 102 ANSI/IESNA RP-27.2-2000 Title ................. Recommended Practice for Photobiological Safety for Lamps and Lamp Systems--Measurement Techniques ------------------------------------------------------------------------ 103 ANSI/IESNA RP-27.3-1996 Title ................. Recommended Practice for Photobiological Safety Lamps--Risk Group Classification and Labeling ------------------------------------------------------------------------ 128 IEEE N42.13-2004 Withdrawn and 141 Calibration and Usage of replaced ``Dose Calibrator'' with newer Ionization Chambers for version the Assay of Radionuclides ------------------------------------------------------------------------ H. Sterility ------------------------------------------------------------------------ 53 ANSI/AAMI ST66, Relevant ................. Sterilization of health guidance care products--Chemical indicators--Part 2: Indicators for Air Removal Test Sheets and Packs ------------------------------------------------------------------------ 74 ANSI/AAMI ST60, Extent of ................. Sterilization of health recognition care products--Chemical and relevant indicators--Part 1: guidance General requirements ------------------------------------------------------------------------ [[Page 16316]] 92 ASTM F2097-05, Standard Withdrawn and 167 Guide for Design and replaced Evaluation of Primary with newer Packaging for Medical version Products ------------------------------------------------------------------------ 151 ASTM F2338-05, Standard Withdrawn and 168 Test Method for replaced Nondestructive Detection with newer of Leaks in Packages by version Vacuum Decay Method ------------------------------------------------------------------------ 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: 014, follows: Table 2. ------------------------------------------------------------------------ Reference No. and Item No. Title of Standard Date ------------------------------------------------------------------------ A. Cardiovascular/Neurology ------------------------------------------------------------------------ 58 Cardiovascular implants--Cardiac ANSI/AAMI/ISO 5840: valve prostheses 2005 ------------------------------------------------------------------------ B. General Hospital/General Plastic Surgery ------------------------------------------------------------------------ 146 Medical electrical equipment--Part ANSI/AAMI/IEC 60601- 2: Particular requirements for 2-21 and 60601-2- safety of infant radiant warmers 21 amendment 1: 2000 ------------------------------------------------------------------------ 147 Standard Practice for Assessment of ASTM D6978-05 Resistance of Medical Gloves to Permeation by Chemotherapy Drugs ------------------------------------------------------------------------ 148 Sterile hypodermic syringes for ISO 7886-3: 2005 single use--Part 3: Auto-disable syringes for fixed-dose immunization ------------------------------------------------------------------------ 149 Standard Practice for Determination ASTM D7160-05 of Expiration Dating for Medical Gloves ------------------------------------------------------------------------ 150 Standard Practice for Determination ASTM D7161-05 of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions ------------------------------------------------------------------------ C. Orthopedic/Physical Medicine ------------------------------------------------------------------------ 183 Standard Practice for Fretting ASTM F1875-98 Corrosion Testing of Modular (2004) Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface ------------------------------------------------------------------------ 184 Implants for Surgery--Staples with ISO 8827: 1988 parallel legs for orthopaedic use-- General requirements ------------------------------------------------------------------------ 185 Standard Test Method for Measuring ASTM F2267-04 Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression ------------------------------------------------------------------------ 186 Test Methods for Intervertebral ASTM F2077-03 Body Fusion Devices ------------------------------------------------------------------------ 187 Standard Specifications and Test ASTM F2193-02 Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System ------------------------------------------------------------------------ 188 Implants for surgery--Wear of total ISO 14243-1: 2002 knee-joint prostheses--Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test ------------------------------------------------------------------------ 189 Implants for surgery--wear of total ISO 14243-2: 2000 knee-joint prostheses--Part 2: Methods of measurement ------------------------------------------------------------------------ 190 Implants for surgery--wear of total ISO 14243-3: 2004 knee-joint prostheses--Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test ------------------------------------------------------------------------ 191 Implants for surgery--Total knee- ISO 14879-1: 2000 joint prostheses--Part 1: Determination of endurance properties of knee tibial trays ------------------------------------------------------------------------ 192 Standard Test Method for ASTM F1223-05 Determination of Total Knee Replacement Constraint ------------------------------------------------------------------------ 193 Standard Specification for Total ASTM F2083-04 Knee Prosthesis ------------------------------------------------------------------------ [[Page 16317]] D. Radiology ------------------------------------------------------------------------ 142 Lasers and laser-related equipment-- ISO 11146-2: 2005 Test methods for laser beam widths, Divergence angles, and beam propagation ratios--Part 2: General astigmatic beams ------------------------------------------------------------------------ 143 Lasers and laser-related equipment-- ISO 15367-2: 2005 Test methods for determination of the shape of a laser beam wavefront--Part 2: Shack-Hartmann sensors ------------------------------------------------------------------------ E. Sterility ------------------------------------------------------------------------ 169 Standard Test Method for Measuring ASTM F2391-05 Package and Seal Integrity Using Helium as Tracer Gas ------------------------------------------------------------------------ 170 Standard Guide for Biocompatibility ASTM F2475-05 Evaluation of Medical Device Packaging Materials ------------------------------------------------------------------------ 171 Chemical Indicators--Guidance on ANSI/AAMI/ISO the selection, use, and 15882: 2003 interpretation of results ------------------------------------------------------------------------ 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 Web 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 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'' on 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 notice announcing ``Modifications to the List of Recognized Standards, Recognition List Number: 014'' 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. Submit a single copy of electronic comments or two paper copies of any mailed comments, 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: 014. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register. Dated: March 23, 2006 Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-4695 Filed 3-30-06; 8:45 am] BILLING CODE 4160-01-S
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