[Federal Register Volume 71, Number 121 (Friday, June 23, 2006)]
[Notices]
[Pages 36121-36125]
From the Federal Register Online via the Government Printing 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.
----------------------------------------------------------------------------------------------------------------
A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
21                       AAMI/ANSI/ISO10993-11:1993, Biological   Extent of recognition          ...............
                          Evaluation of Medical Devices--Part
                          11: Tests for Systemic Toxicity
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
67                       ASTM F756-00, Standard Practice for      Contact person, processes      ...............
                          Assessment of Hemolytic Properties of    affected, and extent of
                          Materials                                recognition
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
82                       ASTM F2147-01, Standard Practice for     Contact person, and processes  ...............
                          Guinea Pigs: Split Adjuvant and Closed   affected
                          Patch Testing for Contact Allergens
----------------------------------------------------------------------------------------------------------------
101                      USP 29-NF21Biological Tests <87>,        Withdrawn and replaced with                109
                          Biological Reactivity Test, In Vitro--   newer version
                          Direct Contact Test
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
134                      USP 29<11>: 2006 Sterile Sodium          Withdrawn and replaced with                152
                          Chloride for Irrigation                  newer version
----------------------------------------------------------------------------------------------------------------
135                      USP 29: 2006 Absorbable Surgical Suture  Withdrawn and replaced with                153
                                                                   newer version
----------------------------------------------------------------------------------------------------------------
136                      USP 29<881>: 2006 Tensile Strength       Withdrawn and replaced with                154
                                                                   newer version
----------------------------------------------------------------------------------------------------------------
137                      USP 29<861>: 2006 Sutures--Diameter      Withdrawn and replaced with                155
                                                                   newer version
----------------------------------------------------------------------------------------------------------------
138                      USP 29<871>: 2006 Sutures Needle         Withdrawn and replaced with                156
                          Attachment                               newer version
----------------------------------------------------------------------------------------------------------------
139                      USP 29<11>: 2006 Sterile Water for       Withdrawn and replaced with                157
                          Irrigation                               newer version
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
162                      USP 29:2006, Biological Indicator for    Withdrawn and replaced with                190
                          Steam Sterilization--Self-Contained      newer version
----------------------------------------------------------------------------------------------------------------
164                      ANSI/AAMI ST81:2004, Sterilization of    Relevant guidance              ...............
                          Medical Devices--Information to be
                          Provided by the Manufacturer for the
                          Processing of Resterilizable Devices
----------------------------------------------------------------------------------------------------------------

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