[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) ...................................
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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.
[[Page 32944]]
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
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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
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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
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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
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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
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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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[[Page 32945]]
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
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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
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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
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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
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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
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\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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