[Federal Register Volume 76, Number 148 (Tuesday, August 2, 2011)]
[Notices]
[Pages 46300-46303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19479]



[[Page 46300]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 027

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: 027'' (Recognition List Number: 027), 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: 027'' 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, Silver Spring, MD 
20993-0002. Send two self-addressed adhesive labels 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: 027 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.

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C 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 as 
follows.

      Table 1--Previous Publications of Standard Recognition Lists
------------------------------------------------------------------------
 
------------------------------------------------------------------------
February 25, 1998 (63 FR 9561)............  March 31, 2006 (71 FR
                                             16313).
October 16, 1998 (63 FR 55617)............  June 23, 2006 (71 FR 36121).
July 12, 1999 (64 FR 37546)...............  November 3, 2006 (71 FR
                                             64718).
November 15, 2000 (65 FR 69022)...........  May 21, 2007 (72 FR 28500).
May 7, 2001 (66 FR 23032).................  September 12, 2007 (72 FR
                                             52142).
January 14, 2002 (67 FR 1774).............  December 19, 2007 (72 FR
                                             71924).
October 2, 2002 (67 FR 61893).............  September 9, 2008 (73 FR
                                             52358)
April 28, 2003 (68 FR 22391)..............  March 18, 2009 (74 FR
                                             11586).
March 8, 2004 (69 FR 10712)...............  September 8, 2009 (74 FR
                                             46203).
June 18, 2004 (69 FR 34176)...............  May 5, 2010 (75 FR 24711).
October 4, 2004 (69 FR 59240).............  June 10, 2010 (75 FR 32943).
May 27, 2005 (70 FR 30756)................  October 4, 2010 (75 FR
                                             61148).
November 8, 2005 (70 FR 67713)............  March 14, 2011 (76 FR
                                             13631).
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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: 027

    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: 027'' 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--Modifications to the List of Recognized Standards
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                                             Replacement
           Old recognition No.               recognition                   Title of standard \1\                                  Change
                                                 No.
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A. Cardiovascular:

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    3-75.................................  ..............  ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/    Extent of recognition, Type of
                                                            A1:2003 Manual, electronic or automated                standard.
                                                            sphygmomanometers.
    3-78.................................  ..............  ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical       Extent of recognition and Type of
                                                            equipment--Part 2-30: Particular requirements for      standard.
                                                            the basic safety and essential performance of
                                                            automated noninvasive sphygmomanometers.
    3-80.................................  ..............  ANSI/AAMI/ISO 81060-1:2007 Non-invasive                Extent of recognition and Type of
                                                            sphygmomanometers--Part 1: Requirements and test       standard.
                                                            methods for non-automated measurement type.
    3-81.................................  ..............  ANSI/AAMI/ISO 81060-2:2009 Non-invasive                Extent of recognition and Type of
                                                            sphygmomanometers--Part 2: Clinical validation of      standard.
                                                            automated measurement type.
B. General:
    5-64.................................            5-65  ANSI/AAMI/ISO 80369-1: 2010 Small bore connectors for  Withdrawn and replaced with newer
                                                            liquids and gases in health care applications--Part    version.
                                                            1: General requirements.
C. Materials:
    8-101................................  ..............  ASTM F2118-03 (Reapproved 2009), Standard Test Method  Contact Person.
                                                            for Constant Amplitude of Force Controlled Fatigue
                                                            Testing of Acrylic Bone Cement.
D. Ophthalmic:
    10-43................................  ..............  ISO 11979-8 Second Edition 2006-07-01 Ophthalmic       Extent of recognition.
                                                            implants--Intraocular lenses--Part 8: Fundamental
                                                            requirements.
    10-56................................  ..............  ANSI Z80.12-2007 Ophthalmics--Multifocal Intraocular   Title, Extent of recognition.
                                                            Lenses.
    10-57................................  ..............  ANSI Z80.13-2007 Ophthalmics--Phakic Intraocular       Title, Extent of recognition.
                                                            Lenses..
E. Orthopedics:
    11-79................................  ..............  ISO 7206-8:1995, Implants for Surgery--Partial and     Withdrawn. See item 11-225.
                                                            Total Hip Joint Prostheses--Part 8: Endurance
                                                            Performance of Stemmed Femoral Components with
                                                            Application of Torsion.
    11-220...............................  ..............  ASTM F 2068-09, Standard Specification for Femoral     Extent of Recognition, Type of
                                                            Prostheses--Metallic Implants.                         standard and Related CFR Citations
                                                                                                                   and Procodes.
F. Sterility:
    14-228...............................  ..............  ANSI/AAMI/ISO 11135-1:2007 Sterilization of health     Relevant Guidance.
                                                            care products--Ethylene oxide--Part 1: Requirements
                                                            for development, validation and routine control of a
                                                            sterilization process for medical devices.
    14-295...............................  ..............  ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical   Relevant Guidance.
                                                            devices--Information to be provided by the
                                                            manufacturer for the processing of resterilizable
                                                            medical devices.
    14-119...............................          14-311  ANSI/AAMI ST55:2010 Table-top steam sterilizers......  Withdrawn and replaced with newer
                                                                                                                   version.
14-280...................................          14-312  ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text)      Withdrawn and replaced with newer
                                                            Comprehensive guide to steam sterilization and         version.
                                                            sterility assurance in health care facilities.
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\1\ All standard titles in this table conform to the style requirements of the respective organizations.

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: 027.

                                                Table 3--New Entries to the List of Recognized Standards
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            Recognition No.                            Title of standard \1\                                   Reference No. and date
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A. Anesthesia:
    1-85..............................  Medical electrical equipment--Part 2-61:            ISO 80601-2-61 First edition 2011-04-01.
                                         Particular requirements for basic safety and
                                         essential performance of pulse oximeter equipment.
B. Dental/ENT:
    4-195.............................  Dentistry-Implants-Dynamic fatigue test for         ISO 14801 Second Edition 2007-11-15.
                                         endosseous dental implants.
C. General:

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    5-66..............................  Medical electrical equipment--Part 1-10: General    IEC 60601-1-10 Edition 1.0 2007-11.
                                         requirements for basic safety and essential
                                         performance--Collateral Standard: Requirements
                                         for the development of physiologic closed-loop
                                         controllers.
    5-67..............................  Medical devices--Application of usability           ANSI/AAMI/IEC 62366:2007.
                                         engineering to medical devices.
D. General Hospital/General Plastic
 Surgery:
    6-253.............................  Hoists for the transfer of disabled persons--       ISO 10535 Second edition 2006-12-15.
                                         Requirements and test methods.
E. IVD:
    7-219.............................  Quality Assurance for Design Control and            CLSI I/LA28-A2.
                                         Implementation of Immunohistochemistry Assays;
                                         Approved Guideline--Second Edition.
    7-220.............................  Quantitative D-dimer for the Exclusion of Venous    CLSI H59-A.
                                         Thromboembolic Disease; Approved Guideline.
F. Nanotechnology:
    18-2..............................  Standard Guide for Handling Unbound Engineered      ASTM E 2535-07.
                                         Nanoscale Particles in Occupational Settings.
G. OB-GYN/GU:
    9-67..............................  Standard Test Method for Determining Compatibility  ASTM D7661-10.
                                         of Personal Lubricants with Natural Rubber Latex
                                         Condoms.
    9-68..............................  Male condoms--Requirements and test methods for     ISO 23409 First edition 2011-02-15.
                                         condoms made from synthetic materials.
H. Ophthalmic:
    10-64.............................  Ophthalmics Optics--Intraocular Lenses............  ANSI Z80.7-2002.
    10-65.............................  Ophthalmic instruments--Endoilluminators--          ISO 15752 Second edition 2010-01-15.
                                         Fundamental requirements and test methods for
                                         optical radiation safety.
    10-66.............................  Optics and photonics--Operation microscopes--Part   ISO 10936-2 Second edition 2010-01-15.
                                         2: Light hazard from operation microscopes used
                                         in ocular surgery.
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                                                                      I. Orthopedic
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11-225................................  Implants for surgery--Partial and total hip joint   ISO 7206-4 Third edition 2010-06-15.
                                         prostheses--Part 4: Determination of endurance
                                         properties and performance of stemmed femoral
                                         components.
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                                                                      J. Radiology
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12-227................................  Ultrasonics--Pulse-echo scanners--Part 1:           IEC 61391-1 First edition 2006-07.
                                         Techniques for calibrating spatial measurement
                                         systems and measurement of system point-spread
                                         function response.
12-228................................  Ultrasonics--Pulse-echo scanners--Part 2:           IEC 61391-2 Edition 1.0 2010-01.
                                         Measurement of maximum depth of penetration and
                                         local dynamic range.
12-229................................  Medical electrical equipment--Radiation dose        IEC PAS 61910-1 First edition 2007-07.
                                         documentation--Part 1: Equipment for radiography
                                         and radioscopy.
12-230................................  Primary user controls for interventional            NEMA XR 24-2008.
                                         angiography x-ray equipment.
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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 FD&C Act by 
submitting such recommendations, with reasons for the recommendation, 
to the contact person (see FOR FURTHER INFORMATION CONTACT). To be 
properly considered such recommendations should contain, at a minimum, 
the following information: (1) Title of the standard; (2) any reference 
number and date; (3) name and address of the national or international 
standards development organization; (4) a proposed list of devices for 
which a declaration of conformity to this standard should routinely 
apply; and (5) a brief identification of the testing or performance or 
other characteristics of the device(s) that would be addressed by a 
declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. CDRH maintains a site on 
the Internet for easy access to information including text, graphics, 
and files that you may download to a personal computer with access to 
the Internet. Updated on a regular basis, the CDRH

[[Page 46303]]

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: 027'' 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 sent 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: 027. These modifications to the list or recognized standards 
are effective upon publication of this notice in the Federal Register.

    Dated: July 28, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19479 Filed 8-1-11; 8:45 am]
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