[Federal Register Volume 71, Number 121 (Friday, June 23, 2006)]
[Notices]
[Pages 36121-36125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9959]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0226]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 015
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: 015'' (Recognition List Number: 015), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit written or electronic 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: 015'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health (HFZ-220), Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send
two self-addressed adhesive labels to assist that office in processing
your requests, or fax your request to 301-443-8818. 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 http://www.fda.gov/cdrh/fedregin.html. See section VI
of this document for electronic access to the
[[Page 36122]]
searchable database for the current list of FDA recognized consensus
standards, including Recognition List Number: 015 modifications and
other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 12720
Twinbrook Pkwy., MD 20857, 301-827-0021.
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.
In Federal Register notices published on 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), June 18, 2004 (69 FR 34176), October 4, 2004 (69 FR 59240), May
27, 2005 (70 FR 30756), November 8, 2005 (70 FR 67713), and March 31,
2006 (71 FR 16313), FDA modified its initial list of FDA recognized
consensus standards.
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: 015
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: 015'' to identify these current
modifications.
In table 1 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 1.
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Replacement
Old Item No. Standard Change Item No.
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A. Biocompatibility
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21 AAMI/ANSI/ISO10993-11:1993, Biological Extent of recognition ...............
Evaluation of Medical Devices--Part
11: Tests for Systemic Toxicity
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66 ASTM F2148-01, Standard Practice for Contact person, processes ...............
Evaluation of Delayed Contact affected, and extent of
Hypersensitivity Using the Murine recognition
Local Lymph Node Assay
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67 ASTM F756-00, Standard Practice for Contact person, processes ...............
Assessment of Hemolytic Properties of affected, and extent of
Materials recognition
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73 ASTM F2065-00e1, Standard Practice for Contact person, processes ...............
Testing for Alternative Pathway affected, and extent of
Complement Activation in Serum by recognition
Solid Materials
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82 ASTM F2147-01, Standard Practice for Contact person, and processes ...............
Guinea Pigs: Split Adjuvant and Closed affected
Patch Testing for Contact Allergens
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101 USP 29-NF21Biological Tests <87>, Withdrawn and replaced with 109
Biological Reactivity Test, In Vitro-- newer version
Direct Contact Test
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102 USP 29-NF21Biological Tests <87>, Withdrawn and replaced with 110
Biological Reactivity Test, In Vitro-- newer version
Elution Test
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103 USP 29-NF21Biological Tests <88>, Withdrawn and replaced with 111
Biological Reactivity Test, In Vivo newer version
Procedure--Preparation of Sample
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104 USP 29-NF21Biological Tests <88>, Withdrawn and replaced with 112
Biological Reactivity Test, In Vitro, newer version
Classification of Plastics--
Intracutaneous Test
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[[Page 36123]]
105 USP 29-NF21Biological Tests <88>, Withdrawn and replaced with 113
Biological Reactivity Test, In Vitro, newer version
Classification of Plastics--Systemic
Injection Test
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B. Dental/Ear, Nose, and Throat
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83 ISO 11498 Dental Handpieces: Dental Low Contact person, and processes ...............
Voltage Electrical Motors affected
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127 ANSI/ADA Specification No. 58:2004, Contact person ...............
Root Canal Files, Type H (Hedstrom)
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C. General Hospital/General Plastic Surgery
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133 USP 29: 2006 Nonabsorbable Surgical Withdrawn and replaced with 151
Suture newer version
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134 USP 29<11>: 2006 Sterile Sodium Withdrawn and replaced with 152
Chloride for Irrigation newer version
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135 USP 29: 2006 Absorbable Surgical Suture Withdrawn and replaced with 153
newer version
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136 USP 29<881>: 2006 Tensile Strength Withdrawn and replaced with 154
newer version
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137 USP 29<861>: 2006 Sutures--Diameter Withdrawn and replaced with 155
newer version
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138 USP 29<871>: 2006 Sutures Needle Withdrawn and replaced with 156
Attachment newer version
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139 USP 29<11>: 2006 Sterile Water for Withdrawn and replaced with 157
Irrigation newer version
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140 USP 29<11>: 2006 Heparin Lock Flush Withdrawn and replaced with 158
Solution newer version
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141 USP 29<11>: 2006 Sodium Chloride Withdrawn and replaced with 159
Injection newer version
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D. Sterility
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52 ANSI/AAMI ST59:1999, Sterilization of Contact person and relevant ...............
Health Care Products--Biological guidance
Indicators Part 1: General
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70 AAMI/ANSI/ISO 14161:2000, Sterilization Contact person ...............
of Health Care Products--Biological
Indicators--Guidance for the
Selection, Use and Interpretation of
Results, 2 ed.
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72 ANSI/AAMI ST33:1996, Guidelines for the Contact person and processes ...............
Selection and Use of Reusable Rigid affected
Sterilization Container Systems for
Ethylene Oxide Sterilization in Health
Care Facilities
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94 AOAC 6.2.01:2005, Official Method Withdrawn and replaced with 172
955.14, Testing Disinfectants Against newer version
Salmonella Choleraesuis, Use-Dilution
Method
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95 AOAC 6.2.02:2005, Official Method Withdrawn and replaced with 173
991.47, Testing Disinfectants Against newer version
Salmonella Choleraesuis, Hard Surface
Carrier Test Method
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96 AOAC 6.2.03:2005, Official Method Withdrawn and replaced with 174
991.48, Testing Disinfectants Against newer version
Staphylococcus Aureus, Hard Surface
Carrier Test Method
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97 AOAC 6.2.04:2005, Official Method Withdrawn and replaced with 175
955.15, Testing Disinfectants Against newer version
Staphylococcus Aureus, Use-Dilution
Method
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[[Page 36124]]
98 AOAC 6.2.05:2005, Official Method Withdrawn and replaced with 176
991.49, Testing Disinfectants Against newer version
Pseudomonas Aeruginosa, Hard Surface
Carrier Test Method
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99 AOAC 6.2.06:2005, Official Method Withdrawn and replaced with 177
964.02, Testing Disinfectants Against newer version
Pseudomonas Aeruginosa, Use-Dilution
Method
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100 AOAC 6.3.02:2005, Official Method Withdrawn and replaced with 178
955.17, Fungicidal Activity of newer version
Disinfectants Using Trichophyton
Mentagrophytes
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101 AOAC 6.3.05:2005, Official Method Withdrawn and replaced with 179
966.04, Sporicidal Activity of newer version
Disinfectants
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102 AOAC 6.3.06:2005, Official Method Withdrawn and replaced with 180
965.12, Tuberculocidal Activity of newer version
Disinfectants
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104 AAMI/ANSI ST58:2005, Safe Use and Withdrawn and replaced with 181
Handling of Glutaraldehyde-Based newer version
Products in Health Care Facilities
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116 ANSI/AAMI ST72:2002, Bacterial Relevant guidance ...............
Endotoxins--Test Methodologies,
Routine Monitoring, and Alternatives
to Batch Testing
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117 ANSI/AAMI ST35:2003, Safe Handling and Relevant guidance ...............
Biological Decontamination of Medical
Devices in Health Care Facilities and
in Nonclinical Settings
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153 USP 29:2006, Biological Indicator for Withdrawn and replaced with 182
Dry Heat Sterilization, Paper Carrier newer version
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154 USP 29:2006, Biological Indicator for Withdrawn and replaced with 183
Ethylene Oxide Sterilization, Paper newer version
Carrier
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155 USP 29:2006, Biological Indicator for Withdrawn and replaced with 184
Steam Sterilization, Paper Carrier newer version
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156 USP29:2006, <61> Microbial Limits Test Withdrawn and replaced with 185
newer version
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157 USP 29:2006, <71>, Microbiological Withdrawn and replaced with 186
Tests, Sterility Tests newer version
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158 USP29:2006, <85>, Biological Tests and Withdrawn and replaced with 187
Assays, Bacterial Endotoxin Test (LAL) newer version
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159 USP29:2006 <151>, Pyrogen Test (USP Withdrawn and replaced with 188
Rabbit Test) newer version
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160 USP29:2006 <1211>, Sterilization and Withdrawn ...............
Sterility Assurance of Compendial
Articles
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161 USP29:2006 <161>, Transfusion and Withdrawn and replaced with 189
Infusion Assemblies and Similar newer version
Medical Devices
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162 USP 29:2006, Biological Indicator for Withdrawn and replaced with 190
Steam Sterilization--Self-Contained newer version
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164 ANSI/AAMI ST81:2004, Sterilization of Relevant guidance ...............
Medical Devices--Information to be
Provided by the Manufacturer for the
Processing of Resterilizable Devices
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III. Listing of New Entries
The listing of new entries and consensus standards added as
modifications to the list of recognized standards under Recognition
List Number: 015, follows:
[[Page 36125]]
Table 2.
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Item No. Title of Standard Reference No. and Date
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A. Sterility
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191 Aseptic Processing of ISO 13408-4:2005
Health Care Products--Part
4: Clean-in-Place
Technologies
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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 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, 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 ``Modifications to the List of
Recognized Standards, Recognition List Number: 015'' will be available
on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/cdrh.
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/cdrh/stdsprog.html.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/cdrh/fedregin.html.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. 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: 015. These modifications to the list of recognized standards
are effective upon publication of this notice in the Federal Register.
Dated: June 13, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-9959 Filed 6-22-06; 8:45 am]
BILLING CODE 4160-01-S