[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Notices]
[Pages 16313-16317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4695]


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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.

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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: 
[email protected]. 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: 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 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 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 
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: 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