[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
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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
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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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