[Federal Register Volume 75, Number 111 (Thursday, June 10, 2010)]
[Notices]
[Pages 32943-32947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13874]



[[Page 32943]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451] (formerly Docket No. 2004N-0226)


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 024

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: 024'' (Recognition List Number: 024), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit either electronic or written 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: 024'' to the Division of Small Manufacturers, International, 
and Consumer Assistance, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 
4617, Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist that office in processing your requests, or fax your 
request to 301-847-8149. 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.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. 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: 024 modifications and other 
standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301-
796-6574.

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.--Previous Publications of Standard Recognition Lists
February 25, 1998 (63 FR 9561)       November 8, 2005 (70 FR 67713)
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October 16, 1998 (63 FR 55617)       March 31, 2006 (71 FR 16313)
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July 12, 1999 (64 FR 37546)          June 23, 2006 (71 FR 36121)
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November 15, 2000 (65 FR 69022)      November 3, 2006 (71 FR 64718)
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May 7, 2001 (66 FR 23032)            May 21, 2007 (72 FR 28500)
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January 14, 2002 (67 FR 1774)        September 12, 2007 (72 FR 52142)
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October 2, 2002 (67 FR 61893)        December 19, 2007 (72 FR 71924)
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April 28, 2003 (68 FR 22391)         September 9, 2008 (73 FR 52358)
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March 8, 2004 (69 FR 10712)          March, 18, 2009 (74 FR 11586)
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June 18, 2004 (69 FR 34176)          September 8, 2009 (74 FR 46203)
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October 4, 2004 (69 FR 59240)        May 5, 2010 (75 FR 24711)
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May 27, 2005 (70 FR 30756)           ...................................
------------------------------------------------------------------------

    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 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: 024

    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: 024'' 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.

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                           Table 2.--Modifications to the List of Recognized Standards
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  Old Recognition       Replacement
        No.           Recognition No.                 Title of Standard\1\                        Change
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A. Dental/ENT
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4-122               4-187               IEC 60601-2-18 Edition 3.0 2009-08 Medical       Newer version with
                                         electrical equipment--Part 2-18: Particular      transition period
                                         requirements for the basic safety and
                                         essential performance of endoscope equipment
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B. General
----------------------------------------------------------------------------------------------------------------
5-4                 5-52                ANSI/AAMI ES60601-1:2005, Medical Electrical     Newer version with
                                         Equipment--Part 1: General requirements for      transition period
                                         basic safety and essential performance
----------------------------------------------------------------------------------------------------------------
5-28                5-53                IEC 60601-1-2 Third edition 2007-03 Medical      Newer version with
                                         electrical equipment--Part 1-2: General          transition period
                                         requirements for basic safety and essential
                                         performance--Collateral standard:
                                         Electromagnetic compatibility--Requirements
                                         and tests
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5-30                5-54                ANSI/AAMI/IEC 60601-1-2:2007 Medical electrical  Newer version with
                                         equipment--Part 1-2: General requirements for    transition period
                                         basic safety and essential performance--
                                         Collateral standard: Electromagnetic
                                         compatibility--Requirements and tests
----------------------------------------------------------------------------------------------------------------
5-34                5-53                IEC 60601-1-2 Third edition 2007-03 Medical      Newer version with
                                         electrical equipment--Part 1-2: General          transition period
                                         requirements for basic safety and essential
                                         performance--Collateral standard:
                                         Electromagnetic compatibility--Requirements
                                         and tests
----------------------------------------------------------------------------------------------------------------
5-35                5-54                ANSI/AAMI/IEC 60601-1-2:2007 Medical electrical  Newer version with
                                         equipment--Part 1-2: General requirements for    transition period
                                         basic safety and essential performance--
                                         Collateral standard: Electromagnetic
                                         compatibility--Requirements and tests
----------------------------------------------------------------------------------------------------------------
5-49                5-55                IEC 60601-1-8 Second edition 2006-10 Medical     Newer version with
                                         electrical equipment--Part 1-8: General          transition period
                                         requirements for basic safety and essential
                                         performance--Collateral Standard: General
                                         requirements, tests and guidance for alarm
                                         systems in medical electrical equipment and
                                         medical electrical systems
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C. General Hospital/General Plastic Surgery
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6-9                 6-227               ANSI/AAMI/IEC 60601-2-21: 2009 Medical           Newer version with
                                         electrical equipment--Part 2-21: Particular      transition period
                                         requirements for the basic safety and
                                         essential performance of infant radiant
                                         warmers
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6-29                ..................  ANSI/AAMI/IEC 60601-2-19: 2009 Medical           Newer version with
                                         Electrical Equipment--Part 2-19: Particular      transition period
                                         requirements for the basic safety and            Refer to recognition
                                         essential performance of infant incubators       no. 6-230
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6-32                ..................  ANSI/AAMI/IEC60601-2-20: 2009 Medical            Newer version with
                                         Electrical Equipment--Part 2-20: Particular      transition period
                                         requirements for the basic safety and            Refer to recognition
                                         essential performance of infant transport        no. 6-231
                                         incubators
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6-142               ..................  AAMI/ANSI II36:2004 Medical electrical           Newer version with
                                         equipment--Part 2: Particular requirements for   transition period.
                                         safety of baby incubators                        Refer to recognition
                                                                                          no. 6-230
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6-143               ..................  AAMI/ANSI II51:2004 Medical electrical           Newer version with
                                         equipment--Part 2: Particular requirements for   transition period.
                                         safety of transport incubators                   Refer to recognition
                                                                                          no. 6-231
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6-146               6-227               ANSI/AAMI/IEC 60601-2-21:2009 Medical            Newer version with
                                         Electrical Equipment--Part 2-21: Particular      transition period
                                         requirements for the basic safety and
                                         essential performance of infant radiant
                                         warmers
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6-182               ..................  IEC 60601-2-38 1996/Amendment 1:1999 Medical     Newer version with
                                         electrical--Part 2-38: Particular requirements   transition period.
                                         for the safety of electrically operated          Refer to recognition
                                         hospital beds                                    no. 6-233
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6-197               6-228               IEC 60601-2-2 Edition 5.0 2009-02 Medical        Newer version with
                                         electrical equipment--Part 2-2: Particular       transition period
                                         requirements for the basic safety and
                                         essential performance of high frequency
                                         surgical equipment and high frequency surgical
                                         accessories
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D. OB-GYN/Gastroenterology
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9-4                 9-60                IEC 60601-2-16 Edition 3.0 2008-04 Medical       Newer version with
                                         electrical equipment--Part 2-16: Particular      transition period
                                         requirements for basic safety and essential
                                         performance of haemodialysis,
                                         haemodiafiltration and haemofiltration
                                         equipment
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9-42                9-61                IEC 60601-2-18 Edition 3.0 2009-08 Medical       Newer version with
                                         electrical equipment--Part 2-18: Particular      transition period
                                         requirements for the basic safety and
                                         essential performance of endoscopic equipment
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9-46                9-62                IEC 60601-2-2 Edition 5.0 2009-02 Medical        Newer version with
                                         electrical equipment--Part 2-2: Particular       transition period
                                         requirements for the basic safety and
                                         essential performance of high frequency
                                         surgical equipment and high frequency surgical
                                         accessories
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E. Radiology
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12-34               ..................  IEC 60601-2-7 Second edition 1998-02 Medical     Newer version with
                                         electrical equipment--Part 2-7: Particular       transition period.
                                         requirements for the safety of high-voltage      Refer to recognition
                                         generators of diagnostic X-ray generators        no. 12-201
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12-36               ..................  IEC 60601-2-9 (1996-10) Medical electrical       Withdrawn
                                         equipment--Part 2: Particular requirements for
                                         the safety of patient contact dosimeters used
                                         in radiotherapy with electrically connected
                                         radiation detectors--Ed. 2.0
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12-63               12-202              IEC 60601-2-43 Edition 2.0 2010-03 Medical       Newer version with
                                         electrical equipment--Part 2-43: Particular      transition period
                                         requirements for the basic safety and
                                         essential performance of X-ray equipment for
                                         interventional procedures
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12-120              12-203              IEC 60601-2-44 Edition 3.0 2009-02 Medical       Newer version with
                                         electrical equipment--Part 2-44: Particular      transition period
                                         requirements for the basic safety and
                                         essential performance of X-ray equipment for
                                         computed tomography
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12-126              12-204              IEC 60601-2-28 Edition 2.0 2010-03 Medical       Newer version with
                                         electrical equipment--Part 2-28: Particular      transition period
                                         requirements for the basic safety and
                                         essential performance of X-ray tube assemblies
                                         for medical diagnosis
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12-127              ..................  IEC 60601-2-32 First edition 1994-03 Medical     Newer version with
                                         electrical equipment Part 2: Particular          transition period.
                                         requirements for the safety of associated        Refer to recognition
                                         equipment of X-ray equipment                     no. 12-201
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12-147              12-205              IEC 60601-2-5 Edition 3.0 2009-07 Medical        Newer version with
                                         electrical equipment Part 2-5: Particular        transition period
                                         requirements for the basic safety and
                                         essential performance of ultrasonic
                                         physiotherapy equipment
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12-152              12-206              IEC 60601-2-1 Edition 3.0 2009-10 Medical        Newer version with
                                         electrical equipment Part 2-1: Particular        transition period
                                         requirements for the basic safety and
                                         essential performance of electron accelerators
                                         in the range 1 MeV to 50 MeV
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12-189              12-207              IEC 60601-2-33 Edition 3.0 2010-03 Medical       Newer version with
                                         electrical equipment--Part 2-33: Particular      transition period
                                         requirements for the basic safety and
                                         essential performance of magnetic resonance
                                         equipment for medical diagnosis
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12-197              12-208              IEC 60601-2-22 Third edition 2007-05 Medical     Newer version with
                                         electrical equipment--Part 2-22: Particular      transition period
                                         requirements for basic safety and essential
                                         performance of surgical, cosmetic, therapeutic
                                         and diagnostic laser equipment
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12-198              12-209              IEC 60601-2-37 Edition 2.0 2007-08 Medical       Newer version with
                                         electrical equipment--Part 2-37: Particular      transition period
                                         requirements for the basic safety and
                                         essential performance of ultrasonic medical
                                         diagnostic and monitoring equipment
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12-199              12-210              IEC 60601-1-3 Edition 2.0 2008-01 Medical        Newer version with
                                         electrical equipment--Part 1-3: General          transition period
                                         requirements for basic safety and essential
                                         performance--Collateral Standard: Radiation
                                         protection in diagnostic X-ray equipment
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12-200              12-211              IEC 60601-2-29 Edition 3.0 2008-06 Medical       Newer version with
                                         electrical equipment--Part 2-29: Particular      transition period
                                         requirements for the basic safety and
                                         essential performance of radiotherapy
                                         simulators
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\1\ All standard titles in this table conform to the style requirements of the respective organizations.


[[Page 32946]]

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: 024.

        Table 3.--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
  Recognition                                                 Reference
      No.                  Title of Standard\1\              No. & Date
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A. Cardiology
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3-78            Medical electrical equipment--Part 2-30:    ANSI/AAMI/
                 Particular requirements for the basic       IEC 80601-2-
                 safety and essential performance of         30:2009
                 automated noninvasive sphygmomanometers
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B. General Hospital/General Plastic Surgery
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6-229           Medical electrical equipment--Part 2-2:     ANSI/AAMI/
                 Particular requirements for the basic       IEC 60601-2-
                 safety and essential performance of high    2:2009
                 frequency surgery equipment and high
                 frequency surgical accessories
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6-230           Medical Electrical Equipment--Part 2-19:    ANSI/AAMI/
                 Particular requirements for the basic       IEC 60601-2-
                 safety and essential performance of         19:2009
                 infant incubators
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6-231           Medical Electrical Equipment--Part 2-20:    ANSI/AAMI/
                 Particular requirements for the basic       IEC 60601-2-
                 safety and essential performance of         20:2009
                 infant transport incubators
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6-232           Medical electrical equipment--Part 2-56:    ISO 80601-2-
                 Particular requirements for basic safety    56 First
                 and essential performance of clinical       Edition
                 thermometers for body temperature           2009-10-01
                 measurement
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6-233           Medical electrical equipment--Part 2-52:    IEC 60601-2-
                 Particular requirements for the basic       52 Edition
                 safety and essential performance of         1.0 2009-12
                 medical beds
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6-234           Medical Electrical Equipment--Part 2-50:    IEC 60601-2-
                 Particular requirements for the basic       50 Edition
                 safety and essential performance of         2.0 2009-03
                 infant phototherapy equipment
------------------------------------------------------------------------
6-235           Medical Electrical Equipment--Part 2-50:    ANSI/AAMI/
                 Particular requirements for the basic       IEC 60601-2-
                 safety and essential performance of         50: 2009
                 infant phototherapy equipment
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6-236           Medical electrical equipment--Part 2-59:    IEC 80601-2-
                 Particular requirements for the basic       59 Edition
                 safety and essential performance of         1.0 2008-10
                 screening thermographs for human febrile
                 temperature screening
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6-237           CORRIGENDUM 1 Medical electrical            IEC 80601-2-
                 equipment--Part 2-59: Particular            59 Edition
                 requirements for the basic safety and       1.0 2008-10
                 essential performance of screening
                 thermographs for human febrile
                 temperature screening
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6-238           Medical electrical equipment--Part 2-35:    IEC 80601-2-
                 Particular requirements for the basic       35 Edition
                 safety and essential performance of         2.0 2009-10
                 heating devices using blankets, pads or
                 mattresses and intended for heating in
                 medical use
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C. OB-GYN/Gastroenterology
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9-63            Medical electrical equipment--Part 2-16:    IEC 60601-2-
                 Particular requirements for basic safety    16 (Third
                 and essential performance of                edition--20
                 haemodialysis, haemodiafiltration and       08)
                 haemofiltration equipment CORRIGENDUM 1
------------------------------------------------------------------------
9-64            Medical electrical equipment--Part 2-2:     ANSI/AAMI/
                 Particular requirements for the basic       IEC 60601-2-
                 safety and essential performance of high    2:2009
                 frequency surgery equipment and high
                 frequency surgical accessories
------------------------------------------------------------------------
D. Radiology
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12-201          Medical electrical equipment--Part 2-54:    IEC 60601-2-
                 Particular requirements for the basic       54 Edition
                 safety and essential performance of X-ray   1.0 2009-06
                 equipment for radiography and radioscopy
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

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,

[[Page 32947]]

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 ``Modification to the List of 
Recognized Standards, Recognition List Number: 024'' will be available 
on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/MedicalDevices.
    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/MedicalDevices/DeviceRegulationandGuidance/Standards.
    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR 
FURTHER INFORMATION CONTACT) either electronic or written comments 
regarding this document. It is only necessary to send one set of 
comments. It is no longer necessary to send two copies of mailed 
comments. 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: 024. These modifications to the list or recognized standards 
are effective upon publication of this notice in the Federal Register.

    Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13874 Filed 6-9-10; 8:45 am]
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