[Federal Register Volume 72, Number 243 (Wednesday, December 19, 2007)]
[Notices]
[Pages 71924-71930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24580]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0226]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a 
publication containing modifications the agency is making to the list 
of standards FDA recognizes for use in premarket reviews (FDA 
recognized consensus standards). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 019'' (Recognition List Number: 019), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit written or electronic comments concerning this document 
at any time. See section VII of this document for the effective date of 
the recognition of standards announced in this document.

ADDRESSES: Submit written requests for single copies of ``Modifications 
to the List of Recognized Standards, Recognition List Number: 019'' to 
the Division of Small Manufacturers, International and Consumer 
Assistance, Center for Devices and Radiological Health (HFZ-220), Food 
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send 
two self-addressed adhesive labels to assist that office in processing 
your requests, or fax your request to 301-443-8818. Submit written 
comments concerning this document, or recommendations for additional 
standards for recognition, to the contact person (see FOR FURTHER 
INFORMATION CONTACT). Submit electronic comments by e-mail: 
[email protected]. This document may also be accessed on FDA's 
Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. See section VI of this document for electronic 
access to the searchable database for the current list of FDA 
recognized consensus standards, including Recognition List Number: 019 
modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0533.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998 
(63 FR 9561), FDA announced the availability of a guidance entitled 
``Recognition and Use of Consensus Standards.'' The notice described 
how FDA would implement its standard recognition program and provided 
the initial list of recognized standards. Modifications to the initial 
list of recognized standards, as published in the Federal Register, are 
identified in table 1 of this document.

                                 Table 1
------------------------------------------------------------------------
                          Federal Register Cite
-------------------------------------------------------------------------
October 16, 1998 (63 FR 55617)
July 12, 1999 (64 FR 37546)
November 15, 2000 (65 FR 69022)
May 7, 2001 (66 FR 23032)
January 14, 2002 (67 FR 1774)
October 2, 2002 (67 FR 61893)
April 28, 2003 (68 FR 22391)
March 8, 2004 (69 FR 10712)
June 18, 2004 (69 FR 34176)
October 4, 2004 (69 FR 59240)
May 27, 2005 (70 FR 30756)
November 8, 2005 (70 FR 67713)
March 31, 2006 (71 FR 16313)
June 23, 2006 (71 FR 36121)
November 3, 2006 (71 FR 64718)
May 21, 2007 (72 FR 28500)
September 12, 2007 (72 FR 52142)
------------------------------------------------------------------------

    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The agency maintains ``hypertext 
markup

[[Page 71925]]

language (HTML)'' and ``portable document format (PDF)'' versions of 
the list of ``FDA Recognized Consensus Standards.'' Both versions are 
publicly accessible at the agency's Internet site. See section VI of 
this document for electronic access information. Interested persons 
should review the supplementary information sheet for the standard to 
understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 019

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the agency will recognize for 
use in satisfying premarket reviews and other requirements for devices. 
FDA will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the agency's searchable database. FDA will use 
the term ``Recognition List Number: 019 to identify these current 
modifications.
    In table 2 of this document, FDA describes the following 
modifications: (1) The withdrawal of standards and their replacement by 
others; (2) the correction of errors made by FDA in listing previously 
recognized standards; and (3) the changes to the supplementary 
information sheets of recognized standards that describe revisions to 
the applicability of the standards.
    In section III of this document, FDA lists modifications the agency 
is making that involve the initial addition of standards not previously 
recognized by FDA.

                                Table 2.
------------------------------------------------------------------------
 Old Item                                                   Replacement
   No.                Standard                Change         Item No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
11         IEC 60601-3-1:1996-08 Medical  Title Change    ..............
            Electrical Equipment - Part   Contact person
            3-1: Essential Performance
            Requirement for
            Transcutaneous Oxygen and
            Carbon Dioxide Partial
            Pressure Monitoring
            Equipment
------------------------------------------------------------------------
18         ISO 8359:1996 Oxygen           Contact person  ..............
            Concentrators for Medical
            Use - Safety Requirements
------------------------------------------------------------------------
51         ASTM F1100-90(1997) Standard   Contact person  ..............
            Specification for             Relevant
            Ventilators Intended for Use   guidance
            in Critical Care
------------------------------------------------------------------------
57         ASTM F1101-90(2003)e1          Contact person  ..............
            Standard Specification for
            Ventilators Intended for Use
            During Anesthesia
------------------------------------------------------------------------
59         ASTM F1456-01 Standard         Relevant        ..............
            Specification for Minimum      guidance
            Performance and Safety
            Requirements for Capnometers
------------------------------------------------------------------------
60         IEC 60601-2-12:(2001-10)       Contact person  ..............
            Medical Electrical Equipment  Relevant
            - Part 2-12: Particular        guidance
            Requirements for the Safety
            of Lung Ventilators -
            Critical Care Ventilators
------------------------------------------------------------------------
61         IEC 60601-2-13(2003-05):,      Relevant        ..............
            Medical electrical equipment   guidance
            - Part 2-13: Particular
            requirements for the safety
            and essential performance of
            anaesthetic systems
------------------------------------------------------------------------
65         ISO 21647: 2004 Medical        Title Change    ..............
            Electrical Equipment -        Relevant
            Particular Requirements for    guidance
            the Basic Safety and
            Essential Performance of
            Respiratory Gas Monitors
------------------------------------------------------------------------
69         ASTM F1464-93(2005) Standard   Contact person  ..............
            Specification for Oxygen
            Concentrators for
            Domiciliary Use
------------------------------------------------------------------------
70         ASTM F 1246-91 (2005)          Contact person  ..............
            Standard Specification for    Relevant
            Electrically Powered Home      guidance
            Care Ventilators, Part 1 -
            Positive-Pressure
            Ventilators and Ventilator
            Circuits
------------------------------------------------------------------------
71         ISO 10651-5:2006 Lung          Contact person  ..............
            Ventilators for Medical Use -
             Particular Requirements for
            Basic Safety and Essential
            Performance - Part 5: Gas-
            powered Emergency
            Resuscitators
------------------------------------------------------------------------
B. General
------------------------------------------------------------------------
20         ASTM F1140:1988: Standard      Withdrawn       ..............
            Test Method for Failure
            Resistance of Unrestrained
            and Nonrigid Packages for
            Medical Applications
------------------------------------------------------------------------
C. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
21         ISO 10555-3: 1996 Sterile,     Withdrawn                  171
            Single-use Intravascular       duplicate
            Catheters - Part 3: Central
            Venous Catheters
------------------------------------------------------------------------
81         ASTM E1061-01(2007) Standard   Withdrawn and              200
            Specification for Direct-      replaced with
            Reading Liquid Crystal         newer version
            Forehead Thermometers
------------------------------------------------------------------------

[[Page 71926]]

 
111        IEC 60601-2-38: 1996 Medical   Withdrawn                  182
            Electrical Equipment - Part    duplicate
            2: Particular Requirements
            for the Safety of
            Electrically Operated
            Hospital Beds
------------------------------------------------------------------------
117        ASTM F2172-02:, Standard       Contact person  ..............
            Specification for Blood/
            Intravenous Fluid/Irrigation
            Fluid Warmers
------------------------------------------------------------------------
121        ISO 8536-2-2001 Infusion       Withdrawn                  173
            Equipment for Medical Use -    duplicate
            Part 2: Closures for
            Infusion Bottles
------------------------------------------------------------------------
126        ISO 8536-4:2007 Infusion       Withdrawn and              201
            Equipment for Medical Use --   replaced with
            Part 4: Infusion Sets for      newer version
            Single-use, Gravity Feed
------------------------------------------------------------------------
162        ISO 8536-1:2000/Amendment      Withdrawn                  172
            1:2004 Infusion Equipment      duplicate
            for Medical Use - Part 1:
            Infusion Glass Bottles
------------------------------------------------------------------------
D. In Vitro Diagnostics
------------------------------------------------------------------------
31         CLSI H20-A2 Reference          Withdrawn and              130
            Leukocyte (WBC) Differential   replaced with
            Count (Proportional) and       newer version
            Evaluation of Instrumental
            Methods; Approved Standard--
            Second Edition
------------------------------------------------------------------------
E. Materials
------------------------------------------------------------------------
3          ASTM F90-07 Standard           Withdrawn and              145
            Specification for Wrought      replaced with
            Cobalt-20 Chromium-15          newer version
            Tungsten-10 Nickel Alloy for
            Surgical Implant
            Applications (UNS R30605)
------------------------------------------------------------------------
30         ASTM F1537-07 Standard         Withdrawn and              152
            Specification for Wrought      replaced with
            Cobalt-28Chromium-6Molybdenu   newer version
            m Alloys for Surgical
            Implants (UNS R31537, UNS
            R31538, and UNS R31539)
------------------------------------------------------------------------
41         ASTM F2066-07 Standard         Withdrawn and              146
            Specification for Wrought      replaced with
            Titanium-15 Molybdenum Alloy   newer version
            for Surgical Implant
            Applications (UNS R58150)
------------------------------------------------------------------------
42         ASTM F2119-07 Standard Test    Withdrawn and              153
            Method for Evaluation of MR    replaced with
            Image Artifacts from Passive   newer version
            Implants
------------------------------------------------------------------------
45         ASTM F562-07 Standard          Withdrawn and              147
            Specification for Wrought      replaced with
            35Cobalt-35Nickel-20Chromium   newer version
            -10Molybdenum Alloy for
            Surgical Implant
            Applications (UNS R30035)
------------------------------------------------------------------------
48         ASTM F899-07 Standard          Withdrawn and              148
            Specification for Stainless    replaced with
            Steel for Surgical             newer version
            Instruments
------------------------------------------------------------------------
56         ISO 5832-1:2007 Implants for   Withdrawn and              149
            Surgery -- Metallic            replaced with
            Materials -- Part 1: Wrought   newer version
            Stainless Steel
------------------------------------------------------------------------
62         ISO 5832-9:2007 Implants for   Withdrawn and              150
            Surgery - Metallic Materials   replaced with
            - Part 9: Wrought High         newer version
            Nitrogen Stainless Steel
------------------------------------------------------------------------
64         ISO 5832-12:2007 Implants for  Withdrawn and              151
            surgery -- Metallic            replaced with
            materials -- Part 12:          newer version
            Wrought cobalt-chromium-
            molybdenum alloy
------------------------------------------------------------------------
F. OB-GYN/Gastroenterology
------------------------------------------------------------------------
5          IEC 60601-2-18 (1996) Medical  Withdrawn                   42
            Electrical Equipment - Part    duplicate
            2: Particular Requirements
            for the Safety of Endoscopic
            Equipment
------------------------------------------------------------------------
G. Ophthalmic
------------------------------------------------------------------------
35         ISO 10939:2007 Ophthalmic      Contact person  ..............
            Instruments -- Slit-lamp
            Microscopes
------------------------------------------------------------------------
37         ISO 10942:2006 Ophthalmic      Contact person  ..............
            Instruments -- Direct
            ophthalmoscopes
------------------------------------------------------------------------
38         ISO 10943:2006 Ophthalmic      Contact person  ..............
            Instruments -- Indirect
            ophthalmoscopes
------------------------------------------------------------------------
39         ISO 12865:2006 Ophthalmic      Contact person  ..............
            Instruments -- Retinoscopes
------------------------------------------------------------------------
51         ISO 15004-2:2007 Ophthalmic    Contact person  ..............
            Instruments--Fundamental
            Requirements and Test
            Methods Part 2: Light Hazard
            Protection
------------------------------------------------------------------------
H. Radiology
------------------------------------------------------------------------

[[Page 71927]]

 
7          IEC / ISO 10918-1:1994         Withdrawn                  150
            Information Technology--       duplicate
            Digital Compression and
            Coding of Continuous-tone
            Still Images - Part 1:
            Requirements and Guidelines
------------------------------------------------------------------------
76         NU 2-2007 Performance          Withdrawn and              167
            Measurements of Positron       replaced with
            Emission Tomographs            newer version
------------------------------------------------------------------------
84         IEC 60825-1 Ed. 2.0 (2007)     Withdrawn and              168
            Safety of Laser Products -     replaced with
            Part 1: Equipment              newer version
            Classification and
            Requirements
------------------------------------------------------------------------
85         IEC 60601-2-22 Ed. 3.0 (2007)  Withdrawn and              169
            Medical Electrical Equipment   replaced with
            - Part 2-22: Particular        newer version
            Requirements for Basic
            Safety and Essential
            Performance of Surgical,
            Cosmetic, Therapeutic and
            Diagnostic Laser Equipment
------------------------------------------------------------------------
90         IEC 60601-2-1 (1998-06)        Withdrawn                  152
            Medical Electrical Equipment   duplicate
            - Part 2-1: Particular
            Requirements for the Safety
            of Electron Accelerators in
            the Range 1 MeV to 50 MeV
------------------------------------------------------------------------
102        ANSI / IESNA RP-27.2-2000      Contact person  ..............
            Recommended Practice for
            Photobiological Safety for
            Lamps and Lamp Systems -
            Measurement Techniques
------------------------------------------------------------------------
103        ANSI / IESNA RP-27.3-1996      Contact person  ..............
            Recommended Practice for
            Photobiological Safety for
            Lamps - Risk Group
            Classification and Labeling
------------------------------------------------------------------------
112        ISO 11670:2003 Lasers and      Withdrawn                  156
            Laser-related Equipment -      duplicate
            Test Methods for Laser Beam
            Parameters - Beam Positional
            Stability
------------------------------------------------------------------------
114        ISO 13694:2000 Optics and      Withdrawn                  157
            Optical Instruments - Lasers   duplicate
            and Laser-related Equipment -
             Test Methods for Laser Beam
            Power (energy) Density
            Distribution
------------------------------------------------------------------------
119        NEMA PS 3.1 - 3.18 (2007)      Withdrawn and              170
            Digital Imaging and            replaced with
            Communications in Medicine     newer version
            (DICOM) Set
------------------------------------------------------------------------
153        ANSI / IESNA RP-27.1-2005      Contact person  ..............
            Recommended Practice for
            Photobiological Safety for
            Lamps and Lamp Systems -
            General Requirements
------------------------------------------------------------------------
I. Software/Informatics
------------------------------------------------------------------------
4          ANSI/UL 1998 Software in       Relevant        ..............
            Programmable Components        guidance
------------------------------------------------------------------------
5          IEC 60601-3-1:1996-08 Medical  Relevant        ..............
            electrical equipment - Part    guidance
            3-1: Essential performance
            requirement for
            transcutaneous oxygen and
            carbon dioxide partial
            pressure monitoring
            equipment
------------------------------------------------------------------------
8          IEC 62304 Ed. 1.0 Medical      Relevant        ..............
            device software - Software     guidance
            life cycle processes
------------------------------------------------------------------------
J. Sterility
------------------------------------------------------------------------
25         ANSI/AAMI/ISO 11135-1:2007     Withdrawn and              228
            Sterilization of Health Care   replaced with
            Products - Ethylene oxide -    newer version
            Part 1: Requirements for the
            Development, Validation and
            Routine Control of a
            Sterilization Process for
            Medical Devices
------------------------------------------------------------------------
63         ASTM F1886: 1998 (2004)        Relevant        ..............
            Standard Test Method for       guidance
            Determining Integrity of
            Seals for Medical Packaging
            by Visual Inspection
------------------------------------------------------------------------
64         ASTM F1929:1998 (2004)         Relevant        ..............
            Standard Test Method for       guidance
            Detecting Seal Leaks in
            Porous Medical Packaging by
            Dye Penetration
------------------------------------------------------------------------
86         ASTM F1980-07 Standard Guide   Withdrawn and              229
            for Accelerated Aging of       replaced with
            Sterile Barrier Systems for    newer version
            Medical Devices
------------------------------------------------------------------------
120        ASTM D3078:2002 Standard Test  Relevant        ..............
            Method for Determination of    guidance
            Leaks in Flexible Packaging
            by Bubble Emission
------------------------------------------------------------------------
136        AAMI/ANSI ST67:2003            Relevant        ..............
            Sterilization of Health Care   guidance
            Products - Requirements for
            Products Labeled 'Sterile'
            1st edition
------------------------------------------------------------------------
144        ASTM F2203-02(2007) Standard   Withdrawn and              230
            Test Method for Linear         replaced with
            Measurement Using Precision    newer version
            Steel Rule
------------------------------------------------------------------------

[[Page 71928]]

 
145        ASTM F2217-02(2007) Standard   Withdrawn and              231
            Practice for Coating/          replaced with
            Adhesive Weight                newer version
            Determination
------------------------------------------------------------------------
146        ASTM F2227-02(2007) Standard   Withdrawn and              232
            Test Method for Non-           replaced with
            Destructive Detection of       newer version
            Leaks in Non-sealed and
            Empty Medical Packaging
            Trays by CO2 Tracer Gas
            Method
------------------------------------------------------------------------
147        ASTM F2228-02(2007) Standard   Withdrawn and              233
            Test Method for Non-           replaced with
            Destructive Detection of       newer version
            Leaks in Medical Packaging
            Which Incorporates Porous
            Barrier Material by CO2
            Tracer Gas Method
------------------------------------------------------------------------
167        ASTM F2097-07 Standard Guide   Withdrawn and              234
            for Design and Evaluation of   replaced with
            Primary Flexible Packaging     newer version
            for Medical Products
------------------------------------------------------------------------
168        ASTM F2338-05 Standard Test    Relevant        ..............
            Method for Nondestructive      guidance
            Detection of Leaks in
            Packages by Vacuum Decay
            Method
------------------------------------------------------------------------
169        ASTM F2391-05 Standard Test    Relevant        ..............
            Method for Measuring Package   guidance
            and Seal Integrity Using
            Helium as Tracer Gas
------------------------------------------------------------------------
170        ASTM F2475-05 Standard Guide   Relevant        ..............
            for Biocompatibility           guidance
            Evaluation of Medical Device
            Packaging Materials
------------------------------------------------------------------------
193        AAMI/ANSI/ISO 11607-1:2006     Relevant        ..............
            Packaging for Terminally       guidance
            Sterilized Medical Devices -
            Part 1: Requirements for
            Materials, Sterile Barrier
            Systems and Packaging
            Systems, 3ed.
------------------------------------------------------------------------
194        AAMI/ANSI/ISO 11607-2:2006     Relevant        ..............
            Packaging for Terminally       guidance
            Sterilized Medical Devices -
            Part 2: Validation
            Requirements for Forming,
            Sealing and Assembly
            Processes, 1ed.
------------------------------------------------------------------------
196        ASTM F1140-07 Standard Test    Withdrawn and              235
            Methods for Internal           replaced with
            Pressurization Failure         newer version
            Resistance of Unrestrained
            Packages
------------------------------------------------------------------------
197        ASTM F1608:00(2004) Standard   Relevant        ..............
            Test Method for Microbial      guidance
            Ranking of Porous Packaging
            Materials (Exposure Chamber
            Method)
------------------------------------------------------------------------
198        ASTM F2054-07 Standard Test    Withdrawn and              236
            Method for Burst Testing of    replaced with
            Flexible Package Seals Using   newer version
            Internal Air Pressurization
            Within Restraining Plates
------------------------------------------------------------------------
199        ASTM D4169-05 Standard         Relevant        ..............
            Practice for Performance       guidance
            Testing of Shipping
            Containers and Systems
------------------------------------------------------------------------
200        ASTM F88-07 Standard Test      Withdrawn and              237
            Method for Seal Strength of    replaced with
            Flexible Barrier Materials     newer version
------------------------------------------------------------------------
K. Tissue Engineering
------------------------------------------------------------------------
2          ASTM F2103-01(2007)e1          Withdrawn and               12
            Standard Guide for             replaced with
            Characterization and Testing   newer version
            of Chitosan Salts as
            Starting Materials Intended
            for Use in Biomedical and
            Tissue-Engineered Medical
            Product Applications
------------------------------------------------------------------------

III. Listing of New Entries

    In table 3 of this document, FDA provides the listing of new 
entries and consensus standards added as modifications to the list of 
recognized standards under Recognition List Number: 019.

                                Table 3.
------------------------------------------------------------------------
  Item No.            Title of Standard            Reference No. & Date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
76            Anaesthetic and Respiratory                 ISO 26825:2007
               Equipment--User-applied Labels
               for Syringes Containing Drugs
               Used During Anaesthesia--
               Colours, Design and Performance
------------------------------------------------------------------------
B. Dental/ ENT
------------------------------------------------------------------------

[[Page 71929]]

 
145           Dentistry--Membrane Materials for           ISO 22803:2004
               Guided Tissue Regeneration in
               Oral and Maxillofacial Surgery--
               Contents of a Technical File
------------------------------------------------------------------------
146           Dentistry--Metallic Materials for          ISO 22674: 2006
               Fixed and Removable Restorations
               and Appliances
------------------------------------------------------------------------
C. General Hospital/ General Plastic Surgery
------------------------------------------------------------------------
202           Lasers and Laser-related                  ISO 11810-2:2007
               Equipment -- Test Method and
               Classification for the Laser-
               resistance of Surgical Drapes
               and/or Patient-protective Covers
               -- Part 2: Secondary Ignition
------------------------------------------------------------------------
D. Ophthalmic
------------------------------------------------------------------------
53            Ophthalmic optics--Contact Lenses         ISO 18369-1:2006
               -- Part 1: Vocabulary,
               Classification System and
               Recommendations for Labeling
               Specifications
------------------------------------------------------------------------
54            Ophthalmic Optics- Contact Lenses-        ISO 18369-4:2006
                Part 4: Physicochemical
               Properties of Contact Lens
               Materials
------------------------------------------------------------------------
55            Ophthalmic implants --                    ISO 11979-6:2007
               Intraocular Lenses -- Part 6:
               Shelf-life and Transport
               Stability
------------------------------------------------------------------------
E. Radiology
------------------------------------------------------------------------
171           Optics and Photonics -- Microlens         ISO 14880-2:2006
               Arrays -- Part 2: Test Methods
               for Wavefront Aberrations
------------------------------------------------------------------------
172           Optics and Photonics -- Microlens         ISO 14880-3:2006
               Arrays -- Part 3: Test Methods
               for Optical Properties Other
               than Wavefront Aberrations
------------------------------------------------------------------------
173           Optics and Photonics -- Microlens         ISO 14880-4:2006
               Arrays -- Part 4: Test Methods
               for Geometrical Properties
------------------------------------------------------------------------
174           Optics and Photonics -- Lasers              ISO 13697:2006
               and Laser-related Equipment --
               Test Methods for Specular
               Reflectance and Regular
               Transmittance of Optical Laser
               Components
------------------------------------------------------------------------
175           Optics and Photonics -- Lasers              ISO 24013:2006
               and Laser-related Equipment --
               Measurement of Phase Retardation
               of Optical Components for
               Polarized Laser Radiation
------------------------------------------------------------------------
176           Evaluation and Routine Testing in    IEC 61223-3-2 Ed. 2.0
               Medical Imaging Departments -                      (2007)
               Part 3-2: Acceptance Tests -
               Imaging Performance of
               Mammographic X-ray Equipment
------------------------------------------------------------------------
F. Sterility
------------------------------------------------------------------------
238           Sterilization of Health Care           ANSI/AAMI/ISO11140-
               Products - Chemical Indicators -                   5:2007
               Part 5: Class 2 Indicators for
               Bowie and Dick-type Air Removal
               Tests
------------------------------------------------------------------------
239           Aseptic Processing of Health Care         ISO 13408-3:2006
               Products--Part 3: Lyophilization
------------------------------------------------------------------------
240           Aseptic Processing of Health Care         ISO 13408-5:2006
               Products--Part 5: Sterilization-
               in-place
------------------------------------------------------------------------
241           Aseptic Processing of Health Care         ISO 13408-6:2005
               Products--Part 6: Isolator
               Systems
------------------------------------------------------------------------
242           Cleanrooms and Associated                 ISO 14644-3:2005
               Controlled Environments--Part 3:
               Test Methods
------------------------------------------------------------------------
243           Cleanrooms and Associated                 ISO 14644-6:2007
               Controlled Environments--Part 6:
               Vocabulary
------------------------------------------------------------------------
244           Cleanrooms and Associated                 ISO 14644-8:2006
               Controlled Environments - Part
               8: Classification of Airborne
               Molecular Contamination
------------------------------------------------------------------------

IV. List of Recognized Standards

    FDA maintains the agency's current list of FDA recognized consensus 
standards in a searchable database that may be accessed directly at 
FDA's Internet site at 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 the new provision of section 514 of the act by 
submitting such recommendations, with reasons for the recommendation, 
to the contact person (See FOR FURTHER INFORMATION CONTACT). To be 
properly considered such recommendations should contain, at a minimum, 
the following information: (1) Title of the standard; (2) any reference 
number and date; (3) name and address of the national or international 
standards development organization; (4) a proposed list of devices for 
which a declaration of conformity to this standard should routinely 
apply; and (5) a brief identification of the testing or performance or 
other characteristics of

[[Page 71930]]

the device(s) that would be addressed by a declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. CDRH maintains a site on 
the Internet for easy access to information including text, graphics, 
and files that you may download to a personal computer with access to 
the Internet. Updated on a regular basis, the CDRH home page includes 
the guidance as well as the current list of recognized standards and 
other standards related documents. After publication in the Federal 
Register, this notice announcing ``Modification to the List of 
Recognized Standards, Recognition List Number: 019'' will be available 
on the CDRH home page. You may access the CDRH home page at 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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR 
FURTHER INFORMATION CONTACT) written or electronic comments regarding 
this document. Two copies of any mailed comments are to be submitted, 
except that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. FDA will consider any comments received in determining 
whether to amend the current listing of modifications to the list of 
recognized standards, Recognition List Number: 019. These modifications 
to the list or recognized standards are effective upon publication of 
this notice in the Federal Register.

    Dated: December 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24580 Filed 12-18-07; 8:45 am]
BILLING CODE 4160-01-S