[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Pages 64718-64725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18604]


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

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: 016

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: 016'' (Recognition List Number: 016), 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: 016'' to 
the Division of Small Manufacturers, International and Consumer 
Assistance, Center for Devices and Radiological

[[Page 64719]]

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 Web site at http://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: 016 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.
    FDA has modified its initial list of recognized standards in the 
following Federal Register notices:

                                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)
------------------------------------------------------------------------

    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: 016

    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: 016'' 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 2.
------------------------------------------------------------------------
Old Item                                                   Replacement
   No.               Standard                Change          Item No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
39        CGA V-5: 2005, Diameter-Index  Withdrawn and                68
           Safety System                  replaced with
           (Noninterchangeable Low        newer version
           Pressure Connections for
           Medical Gas Applications)
------------------------------------------------------------------------
53        ASTM F1464-93 (2005),          Withdrawn and                69
           Standard Specification for     replaced with
           Oxygen Concentrators for       newer version
           Domiciliary Use
------------------------------------------------------------------------
65        ISO 21647: 2005, Medical       Devices         ...............
           Electrical Equipment--         affected,
           Particular Requirements for    Code of
           the Basic Safety and           Federal
           Essential Performance of       Regulations
           Respiratory Gas Monitors       citation, and
                                          relevant
                                          guidance
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
107       ASTM F1877-05, Standard        Withdrawn and               114
           Practice for                   replaced with
           Characterization of            newer version
           Particles
------------------------------------------------------------------------
108       ASTM F1905-98 (2003),          Title           ...............
           Standard Practice for
           Selecting Tests for
           Determining the Propensity
           of Materials for Cause
           Immunotoxicity
------------------------------------------------------------------------

[[Page 64720]]

 
C. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
49        ANSI/ADA Specification No.     Withdrawn and               130
           17: 1983 (R1999), Denture      replaced with
           Base Temporary Relining        newer version
           Resins
------------------------------------------------------------------------
64        ISO 3107: 2004, Dental Zinc    Withdrawn and               131
           Oxide/Eugenol Cements and      replaced with
           Zinc Oxide Non-Eugenol         newer version
           Cements
------------------------------------------------------------------------
66        ISO 4049: 1988, Dentistry--    Withdrawn.      ...............
           Resin-Based Filling            Refer to item
           Materials                      no. 99
------------------------------------------------------------------------
70        ISO 6874: 2005, Dental Resin-  Withdrawn and               132
           Based Pit and Fissure          replaced with
           Sealants                       newer version
------------------------------------------------------------------------
71        ISO 6876: 2001, Dental Root    Withdrawn and               133
           Canal Sealing Materials        replaced with
                                          newer version
------------------------------------------------------------------------
74        ISO 7494-1: 2004, Dentistry--  Withdrawn and               134
           Dental Units--Part 1:          replaced with
           General Requirements and       newer version
           Test Methods
------------------------------------------------------------------------
114       ANSI/ADA Specification No.     Title           ...............
           48: 1989, Visible Curing
           Units
------------------------------------------------------------------------
116       ISO 10139-1: 2005, Dentistry-- Withdrawn and               135
           Soft Lining Materials for      replaced with
           Removable Dentures--Part 1:    newer version
           Materials for Short-Term Use
------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
83        ASTM D6319-00a (2005),         Withdrawn and               167
           Standard Specification for     replaced with
           Nitrile Examination Gloves     newer version
           for Medical Application
------------------------------------------------------------------------
87        ASTM D3577-06, Standard        Withdrawn and               168
           Specification for Rubber       replaced with
           Surgical Gloves                newer version
------------------------------------------------------------------------
106       ASTM D3772-01 (2005),          Withdrawn and               169
           Standard Specification for     replaced with
           Natural Rubber Finger Cots     newer version
------------------------------------------------------------------------
E. In Vitro Diagnostics
------------------------------------------------------------------------
003       CLSI/NCCLS GP10-A 1995,        Contact person  ...............
           Assessment of the Clinical
           Accuracy of Laboratory Tests
           Using Receiver Operating
           Characteristic (ROC) Plots;
           Approved Guideline
------------------------------------------------------------------------
004       CLSI/NCCLS GP14-A 1996,        Contact person  ...............
           Labeling of Home-Use In
           Vitro Testing Products;
           Approved Guideline
------------------------------------------------------------------------
007       CLSI/NCCLS LA1-A2 1994,        Contact person  ...............
           Assessing the Quality of
           Radioimmunoassay Systems--2d
           ed.; Approved Guideline
------------------------------------------------------------------------
012       CLSI/NCCLS C12-A, Definitions  Contact person  ...............
           of Quantities and
           Conventions Related to Blood
           pH and Gas Analysis;
           Approved Standard
------------------------------------------------------------------------
013       CLSI/NCCLS C21-A, Performance  Contact person  ...............
           Characteristics for Devices
           Measuring PO2 and PCO2 in
           Blood Samples; Approved
           Standard
------------------------------------------------------------------------
015       CLSI/NCCLS C25-A, Fractional   Contact person  ...............
           Oxyhemoglobin, Oxygen
           Content and Saturation, and
           Related Quantities in Blood:
           Terminology, Measurement,
           and Reporting; Approved
           Guideline
------------------------------------------------------------------------
016       CLSI/NCCLS C27-A, Blood Gas    Contact person  ...............
           Preanalytical
           Considerations: Specimen
           Collection, Calibration, and
           Controls; Approved Guideline
------------------------------------------------------------------------
018       CLSI/NCCLS C30-A, Ancillary    Contact person  ...............
           (Bedside) Blood Glucose
           Testing
------------------------------------------------------------------------
038       CLSI/NCCLS I/LA10-A,           Contact person  ...............
           Choriogonadotropin Testing:
           Nomenclature, Reference
           Preparations, Assay
           Performance, and Clinical
           Application; Approved
           Guideline
------------------------------------------------------------------------
039       CLSI/NCCLS I/LA17-A,           Contact person  ...............
           Assessing the Quality of
           Systems for Alpha-
           Fetoprotein (AFP) Assays
           Used in Prenatal Screening
           and Diagnosis of Neural Tube
           Defects; Approved Guideline
------------------------------------------------------------------------

[[Page 64721]]

 
043       CLSI/NCCLS LA4-A3, Blood       Contact person  ...............
           Collection on Filter Paper
           for Neonatal Screening
           Programs; Approved Standard--
           3d ed.
------------------------------------------------------------------------
048       CLSI/NCCLS T/DM6-A, Blood      Contact person  ...............
           Alcohol Testing in the
           Clinical Laboratory;
           Approved Guideline
------------------------------------------------------------------------
051       CLSI/NCCLS GP 27-A, Using      Contact person  ...............
           Proficiency Testing (PT) to
           Improve the Clinical
           Laboratory; Approved
           Guideline
------------------------------------------------------------------------
052       CLSI/NCCLS NRSCL 8-A,          Contact person  ...............
           Terminology and Definitions
           for Use in National
           Committee for Clinical
           Laboratory Standards (NCCLS)
           Documents; Approved Standard
------------------------------------------------------------------------
055       CLSI/NCCLS H18-A2, Procedures  Contact person  ...............
           for the Handling and
           Processing of Blood
           Specimens; Approved
           Guideline
------------------------------------------------------------------------
059       CLSI/NCCLS AUTO2-A,            Contact person  ...............
           Laboratory Automation: Bar
           Codes for Specimen Container
           Identification; Approved
           Standard
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
40        ASTM F2063-05, Standard        Withdrawn and               122
           Specification for Wrought      replaced with
           Nickel-Titanium Shape Memory   newer version
           Alloys for Medical Devices
           and Surgical Implants
------------------------------------------------------------------------
48        ASTM F899-02, Standard         Contact person  ...............
           Specification for Stainless
           Steel for Surgical
           Instruments
------------------------------------------------------------------------
60        ISO 5832-5: 2005, Implants     Withdrawn and               123
           for Surgery--Metallic          replaced with
           Materials--Part 5: Wrought     newer version
           Cobalt-Chromium-Tungsten-
           Nickel Alloy
------------------------------------------------------------------------
65        ISO 5834-2: 2006, Implants     Withdrawn and               127
           for Surgery--Ultra-High-       replaced with
           Molecular-Weight               newer version
           Polyethylene--Part 2:
           Moulded Forms
------------------------------------------------------------------------
67        ISO 7153-1: 1991/Amd. 1:       Contact person  ...............
           1999, Surgical Instruments--
           Metallic Materials--Part 1:
           Stainless Steel
------------------------------------------------------------------------
70        ASTM F2052-06e1, Standard      Withdrawn and               124
           Test Method for Measurement    replaced with
           of Magnetically Induced        newer version
           Displacement Force on
           Medical Devices in the
           Magnetic Resonance
           Environment
------------------------------------------------------------------------
72        ASTM F2213-06, Standard Test   Withdrawn and               128
           Method for Measurement of      replaced with
           Magnetically Induced Torque    newer version
           on Passive Implants in the
           Magnetic Resonance
           Environment
------------------------------------------------------------------------
85        ASTM F1854-01, Standard Test   Contact person  ...............
           Method for Stereological
           Evaluation of Porous
           Coatings on Medical Implants
------------------------------------------------------------------------
86        ASTM F1926-03, Standard Test   Contact person  ...............
           Method for Evaluation of the
           Environmental Stability of
           Calcium Phosphate Coatings
------------------------------------------------------------------------
88        ASTM F2024-00, Standard        Contact person  ...............
           Practice for X-Ray
           Diffraction Determination of
           Phase Content of Plasma-
           Sprayed Hydroxyapatite
           Coatings
------------------------------------------------------------------------
89        ASTM F1873-98, Standard        Contact person  ...............
           Specification for High-
           Purity Dense Yttria
           Tetragonal Zirconium Oxide
           Polycrystal (Y-TZP) for
           Surgical Implant
           Applications
------------------------------------------------------------------------
94        ASTM F601-03, Standard         Contact person  ...............
           Practice for Fluorescent
           Penetrant Inspection of
           Metallic Surgical Implants
------------------------------------------------------------------------
99        ASTM F2004-05, Standard Test   Withdrawn and               125
           Method for Transformation      replaced with
           Temperature of Nickel-         newer version
           Titanium Alloys by Thermal
           Analysis
------------------------------------------------------------------------
103       ASTM F1801-97 (2004),          Contact person  ...............
           Standard Practice for
           Corrosion Fatigue Testing of
           Metallic Implant Materials
------------------------------------------------------------------------
106       ASTM F648-04, Standard         Contact person  ...............
           Specification for Ultra-High-
           Molecular-Weight
           Polyethylene Powder and
           Fabricated Form for Surgical
           Implants
------------------------------------------------------------------------
109       ASTM F561-05a, Standard        Withdrawn and               126
           Practice for Retrieval and     replaced with
           Analysis of Medical Devices,   newer version
           and Associated Tissues and
           Fluids
------------------------------------------------------------------------

[[Page 64722]]

 
111       ASTM F1160-05, Standard Test   Contact person  ...............
           Method for Shear and Bending
           Fatigue Testing of Calcium
           Phosphate and Metallic
           Medical and Composite
           Calcium Phosphate/Metallic
           Coatings
------------------------------------------------------------------------
112       ASTM F1044-05, Standard Test   Contact person  ...............
           Method for Shear Testing of
           Calcium Phosphate Coatings
           and Metallic Coatings
------------------------------------------------------------------------
113       ASTM F1147-05, Standard Test   Contact person  ...............
           Method for Tension Testing
           of Calcium Phosphate and
           Metal Coatings
------------------------------------------------------------------------
117       ASTM F86-04, Standard          Contact person  ...............
           Practice for Surface
           Preparation and Marking of
           Metallic Surgical Implants
------------------------------------------------------------------------
G. Obstetrics-Gynecology (OB-GYN)/Gastroenterology
------------------------------------------------------------------------
28        ANSI/AAMI RD16: 1996/A1: 2002/ Reaffirmation   ...............
           (R)2005, Hemodialyzers
------------------------------------------------------------------------
29        ANSI/AAMI RD17: 1994/A1: 2002/ Reaffirmation   ...............
           (R)2005, Hemodialyzer Blood
           Tubing
------------------------------------------------------------------------
31        ANSI/AAMI ID54: 1996/(R)2005,  Reaffirmation   ...............
           Enteral Feeding Set Adapters
           and Connectors
------------------------------------------------------------------------
H. Ophthalmic
------------------------------------------------------------------------
20        ISO 11979-1: 1999, Ophthalmic  Contact person  ...............
           Implants--Intraocular
           Lenses--Part 1: Vocabulary
------------------------------------------------------------------------
22        ISO 11979-3: 1999, Ophthalmic  Contact person  ...............
           Implants--Intraocular
           Lenses--Part 3: Mechanical
           Properties and Test Methods
------------------------------------------------------------------------
32        ISO 11990: 2003, Optics and    Withdrawn and   ...............
           Optical Instruments--Lasers    transferred
           and Laser-Related Equipment--  to Radiology
           Determination of Laser
           Resistance of Tracheal Tube
           Shafts
------------------------------------------------------------------------
I. Orthopedic/Physical Medicine
------------------------------------------------------------------------
85        ISO 14630: 2005, Non-Active    Withdrawn and               194
           Surgical Implants--General     replaced with
           Requirements                   newer version
------------------------------------------------------------------------
141       ASTM F1612-95 (2005),          Withdrawn and               195
           Standard Practice for Cyclic   replaced with
           Fatigue Testing of Metallic    newer version
           Stemmed Hip Arthroplasty
           Femoral Components With
           Torsion
------------------------------------------------------------------------
142       ASTM F1672-95 (2005),          Withdrawn and               196
           Standard Specification for     replaced with
           Resurfacing Patellar           newer version
           Prosthesis
------------------------------------------------------------------------
150       ASTM F983-86 (2005), Standard  Withdrawn and               197
           Practice for Permanent         replaced with
           Marking of Orthopaedic         newer version
           Implant Components
------------------------------------------------------------------------
162       ASTM F564-02 (2006), Standard  Withdrawn and               201
           Specification and Test         replaced with
           Methods for Metallic Bone      newer version
           Staples
------------------------------------------------------------------------
174       ASTM F382-99 (2003) e1,        Withdrawn and               198
           Standard Specification and     replaced with
           Test Method for Metallic       newer version
           Bone Plates
------------------------------------------------------------------------
176       ASTM F565-04, Standard         Withdrawn and               199
           Practice for Care and          replaced with
           Handling of Orthopedic         newer version
           Implants and Instruments
------------------------------------------------------------------------
193       ASTM F2083-06, Standard        Withdrawn and               200
           Specification for Total Knee   replaced with
           Prosthesis                     newer version
------------------------------------------------------------------------
J. Radiology
------------------------------------------------------------------------
32        ISO 11990: 2003, Optics and    Transferred                 144
 (Opthal   Optical Instruments--Lasers    from
 mic)      and Laser-Related Equipment--  Ophthalmic,
           Determination of Laser         type of
           Resistance of Tracheal Tube    standard, and
           Shafts                         contact
                                          person
------------------------------------------------------------------------
92        IEC 61674 (1997-10), Medical   Withdrawn and               145
           Electrical Cquipment--         replaced
           Dosimeters With Ionization
           Chambers and/or Semi-
           Conductor Detectors as Used
           in X-Ray Diagnostic Imaging
------------------------------------------------------------------------

[[Page 64723]]

 
93        IEC 61674 (2002), Amendment    Withdrawn and               145
           1, Medical Electrical          replaced
           Equipment--Dosimeters With
           Ionization Chambers and/or
           Semi-Conductor Detectors as
           Used in X-Ray Diagnostic
           Imaging
------------------------------------------------------------------------
118       IEC 60601-2-17 (2005),         Withdrawn and               146
           Medical Electrical             replaced with
           Equipment--Part 2-17:          newer version
           Particular Requirements for
           the Safety of Automatically-
           Controlled Brachytherapy
           Afterloading Equipment
------------------------------------------------------------------------
135       IEC 60601-2-5 (2005), Medical  Withdrawn and               147
           Electrical Equipment--Part 2-  replaced with
           5: Particular Requirements     newer version
           for the Safety of Ultrasonic
           Physiotherapy Equipment ed.
           2.0
------------------------------------------------------------------------
8         IEC 60336 (2005), Medical      Withdrawn and               149
           Electrical Equipment--X-Ray    replaced with
           Tube Assemblies for Medical    newer version
           Diagnosis--Characteristics
           of Focal Spots
------------------------------------------------------------------------
K. Sterility
------------------------------------------------------------------------
74        ANSI/AAMI ST 60: 1996,         Withdrawn       ...............
           Sterilization of Health Care
           Products--Chemical
           Indicators--Part 1: General
           Requirements
------------------------------------------------------------------------
103       ISO 11607-2000, Packaging for  Withdrawn       ...............
           Terminally Sterilized
           Medical Devices
------------------------------------------------------------------------

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: 016, follows:

                                                    Table 3.
----------------------------------------------------------------------------------------------------------------
        Item No.                         Title of Standard                         Reference No. and Date
----------------------------------------------------------------------------------------------------------------
A. Dental/ENT
----------------------------------------------------------------------------------------------------------------
136                      Standard Practice for Describing System Output                            ASTM F2504-05
                          of Implantable Middle Ear Hearing Devices
----------------------------------------------------------------------------------------------------------------
B. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
160                      Sterile Single-Use Syringes, With or Without           ISO 8537: 1991/Amendment 1: 2000
                          Needle, for Insulin
----------------------------------------------------------------------------------------------------------------
161                      Sterile, Single-Use Intravascular Catheters--      ISO 10555-1: 1996/Amendment 1: 1999,
                          Part 1: General Requirements                                         Amendment 2: 2004
----------------------------------------------------------------------------------------------------------------
162                      Infusion Equipment for Medical Use--Part 1:          ISO 8536-1: 2000/Amendment 1: 2004
                          Infusion Glass Bottles
----------------------------------------------------------------------------------------------------------------
163                      Stainless Steel Needle Tubing for the                  ISO 9626: 1991/Amendment 1: 2001
                          Manufacture of Medical Devices
----------------------------------------------------------------------------------------------------------------
164                      Sterile, Single-Use Intravascular Catheters--      ISO 10555-5: 1996/Amendment 1: 1999,
                          Part 5: Over-Needle Peripheral Catheters                           Corrigendum 1: 2002
----------------------------------------------------------------------------------------------------------------
165                      Standard Specification for Polychloroprene                                ASTM D6977-04
                          Examination Gloves for Medical Application
----------------------------------------------------------------------------------------------------------------
166                      Standard Specification for Puncture Resistance                            ASTM F2132-01
                          of Materials Used in Containers for Discarded
                          Medical Needles and Other Sharps
----------------------------------------------------------------------------------------------------------------
C. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
124                      Fluorescence Calibration and Quantitative                           CLSI/NCCLS I/LA24-A
                          Measurement of Fluorescence Intensity; Approved
                          Guideline
----------------------------------------------------------------------------------------------------------------
125                      Procedures for the Recovery and Identification             CLSI M28-A2, Vol. 25, No. 16
                          of Parasites from the Intestinal Tract;
                          Approved Guideline
----------------------------------------------------------------------------------------------------------------
126                      Susceptibility Testing of Mycobacteria,                     CLSI M24-A, Vol. 23, No. 18
                          Nocardiae, and Other Aerobic Actinomycetes
----------------------------------------------------------------------------------------------------------------
D. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------

[[Page 64724]]

 
38                       Optics and Optical Instruments--Medical              ISO 8600-3: 1997/Amendment 1: 2003
                          Endoscopes and Endoscopic Accessories Part 3:
                          Determination of Field of View and Direction of
                          View of Endoscopes with Optics
----------------------------------------------------------------------------------------------------------------
39                       Optics and Photonics--Medical Endoscopes and                           ISO 8600-5: 2005
                          Endotherapy Devices--Part 5: Determination of
                          Optical Resolution of Rigid Endoscopes with
                          Optics
----------------------------------------------------------------------------------------------------------------
40                       Optics and Photonics--Medical Endoscopes and                           ISO 8600-6: 2005
                          Endotherapy Devices--Part 6: Vocabulary
----------------------------------------------------------------------------------------------------------------
E. Radiology
----------------------------------------------------------------------------------------------------------------
145                      Medical Electrical Equipment--Dosimeters with     IEC 61674 (1997), (2002), Amendment 1
                          Ionization Chambers and/or Semi-Conductor
                          Detectors as Used in X-Ray Diagnostic Imaging
----------------------------------------------------------------------------------------------------------------
148                      Medical Electrical Equipment--Part 2-37:             IEC 60601-2-37 (2005), Amendment 2
                          Particular Requirements for the Safety of
                          Ultrasonic Medical Diagnostic and Monitoring
                          Equipment
----------------------------------------------------------------------------------------------------------------
F. Software
----------------------------------------------------------------------------------------------------------------
8                        Medical Device Software--Software Life Cycle                   IEC 62304 ed. 1.0 (2006)
                          Processes
----------------------------------------------------------------------------------------------------------------
G. Sterility
----------------------------------------------------------------------------------------------------------------
193                      Packaging for Terminally Sterilized Medical                 ANSI/AAMI/ISO 11607-1: 2006
                          Devices--Part 1: Requirements for Materials,
                          Sterile Barrier Systems, and Packaging Systems,
                          3d ed.
----------------------------------------------------------------------------------------------------------------
194                      Packaging for Terminally Sterilized Medical                 ANSI/AAMI/ISO 11607-2: 2006
                          Devices--Part 2: Validation Requirements for
                          Forming, Sealing, and Assembly Processes, 1st
                          ed.
----------------------------------------------------------------------------------------------------------------
195                      Sterilization of Health Care Products--Chemical             ANSI/AAMI/ISO 11140-1: 2005
                          Indicators--Part 1: General Requirements, 2d
                          ed.
----------------------------------------------------------------------------------------------------------------

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 http://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 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

    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 ``Modifications to the List of 
Recognized Standards, Recognition List Number: 016'' will be available 
on the CDRH home page. You may access the CDRH home page at http://
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 http://www.fda.gov/cdrh/
stdsprog.html.
    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at http://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: 016. These modifications to the list of recognized standards 
are effective upon publication of this notice in the Federal Register.


[[Page 64725]]


    Dated: October 27, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-18604 Filed 11-2-06; 8:45 am]
BILLING CODE 4160-01-S