Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 027, 46300-46303 [2011-19479]
Download as PDF
<![CDATA[
46300
Federal Register / Vol. 76, No. 148 / Tuesday, August 2, 2011 / Notices
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.
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: standards@cdrh.fda.gov. This
document may also be accessed on
FDA’s Internet site at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
erowe on DSK5CLS3C1PROD with NOTICES
SUMMARY:
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).
October 16, 1998 (63
FR 55617).
July 12, 1999 (64 FR
37546).
November 15, 2000
(65 FR 69022).
May 7, 2001 (66 FR
23032).
January 14, 2002 (67
FR 1774).
October 2, 2002 (67
FR 61893).
April 28, 2003 (68 FR
22391).
March 8, 2004 (69 FR
10712).
March 31, 2006 (71
FR 16313).
June 23, 2006 (71
FR 36121).
November 3, 2006
(71 FR 64718).
May 21, 2007 (72 FR
28500).
September 12, 2007
(72 FR 52142).
December 19, 2007
(72 FR 71924).
September 9, 2008
(73 FR 52358)
March 18, 2009 (74
FR 11586).
September 8, 2009
(74 FR 46203).
TABLE 1—PREVIOUS PUBLICATIONS OF
STANDARD RECOGNITION LISTS—
Continued
June 18, 2004 (69 FR
34176).
October 4, 2004 (69
FR 59240).
May 27, 2005 (70 FR
30756).
November 8, 2005 (70
FR 67713).
May 5, 2010 (75 FR
24711).
June 10, 2010 (75
FR 32943).
October 4, 2010 (75
FR 61148).
March 14, 2011 (76
FR 13631).
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
Old recognition No.
Replacement
recognition
No.
Title of standard
1
Change
A. Cardiovascular:
VerDate Mar<15>2010
15:03 Aug 01, 2011
Jkt 223001
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
E:\FR\FM\02AUN1.SGM
02AUN1
46301
Federal Register / Vol. 76, No. 148 / Tuesday, August 2, 2011 / Notices
TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition No.
Replacement
recognition
No.
3–75 .....................
........................
3–78 .....................
........................
3–80 .....................
........................
3–81 .....................
........................
B. General:
5–64 .....................
Title of standard
1
Change
ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/
A1:2003 Manual, electronic or automated sphygmomanometers.
ANSI/AAMI/IEC 80601–2–30:2009 Medical electrical equipment—Part 2–30: Particular requirements for the basic
safety and essential performance of automated
noninvasive sphygmomanometers.
ANSI/AAMI/ISO
81060–1:2007
Non-invasive
sphygmomanometers—Part 1: Requirements and test methods
for non-automated measurement type.
ANSI/AAMI/ISO
81060–2:2009
Non-invasive
sphygmomanometers—Part 2: Clinical validation of automated
measurement type.
Extent of recognition, Type of standard.
5–65
ANSI/AAMI/ISO 80369–1: 2010 Small bore connectors for
liquids and gases in health care applications—Part 1: General requirements.
Withdrawn and replaced with newer
version.
C. Materials:
8–101 ...................
........................
ASTM F2118–03 (Reapproved 2009), Standard Test Method
for Constant Amplitude of Force Controlled Fatigue Testing
of Acrylic Bone Cement.
Contact Person.
D. Ophthalmic:
10–43 ...................
........................
Extent of recognition.
10–56 ...................
........................
10–57 ...................
E. Orthopedics:
11–79 ...................
........................
ISO 11979–8 Second Edition 2006–07–01 Ophthalmic implants—Intraocular lenses—Part 8: Fundamental requirements.
ANSI Z80.12–2007 Ophthalmics—Multifocal Intraocular
Lenses.
ANSI Z80.13–2007 Ophthalmics—Phakic Intraocular Lenses.
11–220 .................
........................
F. Sterility:
14–228 .................
........................
14–295 .................
........................
14–119 .................
14–311
14–280 ........................
14–312
1 All
........................
Extent of recognition and Type of
standard.
Extent of recognition and Type of
standard.
Extent of recognition and Type of
standard.
Title, Extent of recognition.
Title, Extent of recognition.
ISO 7206–8:1995, Implants for Surgery—Partial and Total Withdrawn. See item 11–225.
Hip Joint Prostheses—Part 8: Endurance Performance of
Stemmed Femoral Components with Application of Torsion.
ASTM F 2068–09, Standard Specification for Femoral Pros- Extent of Recognition, Type of standtheses—Metallic Implants.
ard and Related CFR Citations and
Procodes.
ANSI/AAMI/ISO 11135–1:2007 Sterilization of health care
products—Ethylene oxide—Part 1: Requirements for development, validation and routine control of a sterilization
process for medical devices.
ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical devices—Information to be provided by the manufacturer for
the processing of resterilizable medical devices.
ANSI/AAMI ST55:2010 Table-top steam sterilizers .................
ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
Relevant Guidance.
Relevant Guidance.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
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
Title of standard 1
Reference No. and date
Medical electrical equipment—Part 2–61: Particular requirements for
basic safety and essential performance of pulse oximeter equipment.
ISO 80601–2–61 First edition 2011–04–01.
Dentistry-Implants-Dynamic fatigue test for endosseous dental implants.
ISO 14801 Second Edition 2007–11–15.
erowe on DSK5CLS3C1PROD with NOTICES
Recognition No.
A. Anesthesia:
1–85 .............................
B. Dental/ENT:
4–195 ...........................
C. General:
VerDate Mar<15>2010
15:03 Aug 01, 2011
Jkt 223001
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
E:\FR\FM\02AUN1.SGM
02AUN1
46302
Federal Register / Vol. 76, No. 148 / Tuesday, August 2, 2011 / Notices
TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
5–66 .............................
5–67 .............................
D. General Hospital/General Plastic Surgery:
6–253 ...........................
E. IVD:
7–219 ...........................
7–220 ...........................
F. Nanotechnology:
18–2 .............................
G. OB–GYN/GU:
9–67 .............................
9–68 .............................
H. Ophthalmic:
10–64 ...........................
10–65 ...........................
10–66 ...........................
Reference No. and date
Medical electrical equipment—Part 1–10: General requirements for
basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllers.
Medical devices—Application of usability engineering to medical devices.
IEC 60601–1–10 Edition 1.0 2007–11.
Hoists for the transfer of disabled persons—Requirements and test
methods.
ISO 10535 Second edition 2006–12–15.
Quality Assurance for Design Control and Implementation of
Immunohistochemistry Assays; Approved Guideline—Second Edition.
Quantitative D-dimer for the Exclusion of Venous Thromboembolic
Disease; Approved Guideline.
CLSI I/LA28–A2.
Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings.
ASTM E 2535–07.
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
Male condoms—Requirements and test methods for condoms made
from synthetic materials.
ASTM D7661–10.
Ophthalmics Optics—Intraocular Lenses .............................................
Ophthalmic instruments—Endoilluminators—Fundamental requirements and test methods for optical radiation safety.
Optics and photonics—Operation microscopes—Part 2: Light hazard
from operation microscopes used in ocular surgery.
ANSI Z80.7–2002.
ISO 15752 Second edition 2010–01–15.
ANSI/AAMI/IEC 62366:2007.
CLSI H59–A.
ISO 23409 First edition 2011–02–15.
ISO 10936–2 Second edition 2010–01–15.
I. Orthopedic
11–225 ................................
Implants for surgery—Partial and total hip joint prostheses—Part 4:
Determination of endurance properties and performance of
stemmed femoral components.
ISO 7206–4 Third edition 2010–06–15.
J. Radiology
12–227 ................................
12–228 ................................
12–229 ................................
12–230 ................................
1 All
Ultrasonics—Pulse-echo scanners—Part 1: Techniques for calibrating spatial measurement systems and measurement of system
point-spread function response.
Ultrasonics—Pulse-echo scanners—Part 2: Measurement of maximum depth of penetration and local dynamic range.
Medical electrical equipment—Radiation dose documentation—Part
1: Equipment for radiography and radioscopy.
Primary user controls for interventional angiography x-ray equipment
IEC 61391–2 Edition 1.0 2010–01.
IEC PAS 61910–1 First edition 2007–07.
NEMA XR 24–2008.
standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
erowe on DSK5CLS3C1PROD with NOTICES
IEC 61391–1 First edition 2006–07.
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 https://
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
VerDate Mar<15>2010
15:03 Aug 01, 2011
Jkt 223001
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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
E:\FR\FM\02AUN1.SGM
02AUN1
Federal Register / Vol. 76, No. 148 / Tuesday, August 2, 2011 / Notices
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 https://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
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards.
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://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]
erowe on DSK5CLS3C1PROD with NOTICES
BILLING CODE 4160–01–P
VerDate Mar<15>2010
15:03 Aug 01, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0490]
Guidance for Industry and Food and
Drug Administration Staff:
Investigational New Drug Applications
for Minimally Manipulated, Unrelated
Allogeneic Placental/Umbilical Cord
Blood Intended for Hematopoietic
Reconstitution for Specified
Indications; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry and FDA Staff:
Investigational New Drug Applications
(INDs) for Minimally Manipulated,
Unrelated Allogeneic Placental/
Umbilical Cord Blood Intended for
Hematopoietic Reconstitution for
Specified Indications,’’ dated June 2011.
The guidance document provides advice
to potential sponsors to assist in the
submission of an IND for certain
minimally manipulated hematopoietic
stem/progenitor cells from placental/
umbilical cord blood, from an unrelated
allogeneic cord blood donor and
intended for hematopoietic
reconstitution in patients with specified
indications (HPC–Cs), when such HPC–
Cs are not licensed and when a suitable
human leukocyte antigen (HLA)
matched cord blood transplant is
needed for treatment of a patient with
a serious or life-threatening disease or
condition, and there is no satisfactory
alternative treatment. If such HPC–Cs
are made available for clinical use, they
must be distributed under an IND. The
guidance announced in this notice
finalizes the draft guidance of the same
title dated October 2009.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
Frm 00037
Fmt 4703
electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
Notice.
SUMMARY:
PO 00000
46303
Sfmt 4703
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry and FDA Staff: Investigational
New Drug Applications (INDs) for
Minimally Manipulated, Unrelated
Allogeneic Placental/Umbilical Cord
Blood Intended for Hematopoietic
Reconstitution for Specified
Indications,’’ dated June 2011. The
guidance document provides advice to
potential sponsors (e.g., cord blood
banks or registries, transplant centers,
and individual physicians serving as
sponsor-investigators) to assist in the
submission of an IND for certain HPC–
Cs, when such HPC–Cs are not licensed
in accordance with 21 CFR Part 601,
and when a suitable HLA matched cord
blood transplant is needed for treatment
of a patient with a serious or lifethreatening disease or condition, and
there is no satisfactory alternative
treatment. The guidance document is
applicable only to HPC–Cs intended for
hematopoietic reconstitution in patients
with the clinical indications listed in
the guidance. If such HPC–Cs are made
available for clinical use, they must be
distributed under an IND meeting all of
the applicable requirements in part 312
(21 CFR Part 312).
In the Federal Register of October 20,
2009 (74 FR 53751), FDA announced the
availability of the draft guidance of the
same title dated October 2009. FDA
received a few comments on the draft
guidance, and those comments were
considered as the guidance was
finalized. Changes incorporated in the
final guidance include simplifying table
A, which sets forth certain regulatory
requirements and current best practices
with respect to what should be included
in an IND. In addition, organizational
and editorial revisions were made to
improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated October 2009.
In the October 20, 2009, notice
announcing the availability of the draft
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 76, Number 148 (Tuesday, August 2, 2011)]
[Notices]
[Pages 46300-46303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19479]
[[Page 46300]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: standards@cdrh.fda.gov. This document may also be
accessed on FDA's Internet site at https://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).
------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
A. Cardiovascular:
[[Page 46301]]
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recognition No. Title of standard \1\ Reference No. and date
--------------------------------------------------------------------------------------------------------------------------------------------------------
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:
[[Page 46302]]
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Orthopedic
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
J. Radiology
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 https://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 https://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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at https://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]
BILLING CODE 4160-01-P
