[Federal Register Volume 74, Number 172 (Tuesday, September 8, 2009)]
[Notices]
[Pages 46203-46214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21609]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451] (formerly Docket No. 2004N-0226)
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 022
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 46204]]
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: 022'' (Recognition List Number: 022), 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: 022'' 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, rm. 4613, 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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. 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: 022 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.
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 of the act 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 of this
document.
Table 1.--Federal Register Citation
February 25, 1998 (63 FR 9561) May 27, 2005 (70 FR 30756)
------------------------------------------------------------------------
October 16, 1998 (63 FR 55617) November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
July 12, 1999 (64 FR 37546) March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
November 15, 2000 (65 FR 69022) June 23, 2006 (71 FR 36121)
------------------------------------------------------------------------
May 7, 2001 (66 FR 23032) November 3, 2006 (71 FR 64718)
------------------------------------------------------------------------
January 14, 2002 (67 FR 1774) May 21, 2007 (72 FR 28500)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893) September 12, 2007 (72 FR 52142)
------------------------------------------------------------------------
April 28, 2003 (68 FR 22391) December 19, 2007 (72 FR 71924)
------------------------------------------------------------------------
March 8, 2004 (69 FR 10712) September 9, 2008 (73 FR 52358)
------------------------------------------------------------------------
June 18, 2004 (69 FR 34176) March, 18, 2009 (74 FR 11586)
------------------------------------------------------------------------
October 4, 2004 (69 FR 59240) ...................................
------------------------------------------------------------------------
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: 022
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: 022'' 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.
----------------------------------------------------------------------------------------------------------------
Replacement
Old Recognition No. Recognition No. Standard Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-37 1-80 CGA C-9:2004 (Reaffirmed 2008) Standard Withdrawn and replaced
Color Marking of Compressed Gas with newer version
Containers for Medical Use
----------------------------------------------------------------------------------------------------------------
[[Page 46205]]
1-68 1-81 CGA V-5:2008 Diameter-Index Safety System Withdrawn and replaced
Noninterchangeable Low Pressure with newer version
Connections for Medical Gas Applications
----------------------------------------------------------------------------------------------------------------
1-51 ..................... ASTM F1100-90 (1997) Standard Withdrawn
Specification for Ventilators Intended
for Use in Critical Care
----------------------------------------------------------------------------------------------------------------
1-59 ..................... ASTM F1456-01 Standard Specification for Withdrawn
Minimum Performance and Safety
Requirements for Capnometers
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-64 ..................... ANSI/AAMI/ISO 10993-5:1999 Biological Contact person, Extent
Evaluation of Medical Devices--Part 5: of recognition and
Tests for In Vitro Cytotoxicity Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-82 ..................... ASTM F2147-01 Standard Practice for Guinea Contact person and
Pig: Split Adjuvant and Closed Patch Extent of recognition
Testing for Contact Allergens
----------------------------------------------------------------------------------------------------------------
2-83 2-136 ASTM E1262-88 (Reapproved 2008) Standard Withdrawn and replaced
Guide for Performance of Chinese Hamster with newer version
Ovary Cell/Hypoxanthine Guanine
Phosphoribosyl Transferase Gene Mutation
Assay
----------------------------------------------------------------------------------------------------------------
2-84 2-137 ASTM E1263-97 (Reapproved 2008) Standard Withdrawn and replaced
Guide for Conduct of Micronucleus Assays with newer version
in Mammalian Bone Marrow Erythrocytes
----------------------------------------------------------------------------------------------------------------
2-85 2-138 ASTM E1280-97 (Reapproved 2008) Standard Withdrawn and replaced
Guide for Performing the Mouse Lymphoma with newer version
Assay for Mammalian Cell Mutagenicity
----------------------------------------------------------------------------------------------------------------
2-87 ..................... ISO 10993-10:2002 Biological Evaluation of Extent of recognition
Medical Devices--Part 10: Tests for and Relevant guidance
Irritation and Delayed-type
Hypersensitivity
----------------------------------------------------------------------------------------------------------------
2-90 2-139 ASTM E1397-91 (Reapproved 2008) Standard Withdrawn and replaced
Practice for In Vitro Rat Hepatocyte DNA with newer version
Repair Assay
----------------------------------------------------------------------------------------------------------------
2-91 2-140 ASTM E1398-91 (Reapproved 2008) Standard Withdrawn and replaced
Practice for In Vivo Rat Hepatocyte DNA with newer version
Repair Assay
----------------------------------------------------------------------------------------------------------------
2-93 ..................... ASTM F763-04 Standard Practice for Short- Extent of recognition
Term Screening of Implant Materials and Contact person
----------------------------------------------------------------------------------------------------------------
2-94 ..................... ASTM F981-04 Standard Practice for Extent of recognition
Assessment of Compatibility of and Contact person
Biomaterials for Surgical Implants with
Respect to Effect of Materials on Muscle
and Bone
----------------------------------------------------------------------------------------------------------------
2-95 2-141 ASTM F1984-99 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Testing for Whole Complement with newer version
Activation in Serum by Solid Materials
----------------------------------------------------------------------------------------------------------------
2-97 2-142 ASTM F1983-99 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Assessment of Compatibility with newer version
of Absorbable/Resorbable Biomaterials for
Implant Applications
----------------------------------------------------------------------------------------------------------------
2-98 ..................... ANSI/AAMI/ISO 10993-1:2003 Biological Title, Extent of
Evaluation of Medical Devices--Part 1: recognition, Relevant
Evaluation and Testing guidance and Contact
person
----------------------------------------------------------------------------------------------------------------
2-99 2-143 ASTM F1904-98 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Testing the Biological with newer version
Responses to Particles in vivo
----------------------------------------------------------------------------------------------------------------
2-100 ..................... ASTM E1372-95 (Reapproved 2003) Standard Contact person
Test Method for Conducting a 90-Day Oral
Toxicity Study in Rats
----------------------------------------------------------------------------------------------------------------
2-106 2-144 ASTM F619-03 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Extraction of Medical with newer version
Plastics
----------------------------------------------------------------------------------------------------------------
2-108 ..................... ASTM F1905-98(2003) Standard Practice for Contact person and
Selecting Tests for Determining the Extent of recognition
Propensity of Materials to Cause
Immunotoxicity
----------------------------------------------------------------------------------------------------------------
2-114 ..................... ASTM F1877-05 Standard Practice for Extent of recognition
Characterization of Particles and Contact person
----------------------------------------------------------------------------------------------------------------
[[Page 46206]]
2-115 ..................... ASTM F895-84 (Reapproved 2006) Standard Extent of recognition,
Test Method for Agar Diffusion Cell Relevant guidance and
Culture Screening for Cytotoxicity Contact person
----------------------------------------------------------------------------------------------------------------
2-116 2-145 ASTM F1439-03 (Reapproved 2008) Standard Withdrawn and replaced
Guide for Performance of Lifetime with newer version
Bioassay for the Tumorigenic Potential of
Implant Materials
----------------------------------------------------------------------------------------------------------------
2-118 ..................... ANSI/AAMI/ISO 10993-11:2006 Biological Extent of recognition,
Evaluation of Medical Devices--Part 11: Relevant guidance and
Tests for Systemic Toxicity Contact person
----------------------------------------------------------------------------------------------------------------
2-119 ..................... ASTM F813-07 Standard Practice for Direct Contact person
Contact Cell Culture Evaluation of
Materials for Medical Devices
----------------------------------------------------------------------------------------------------------------
2-121 2-146 ASTM F2148-071 Standard Practice for Withdrawn and replaced
Evaluation of Delayed Contact with newer version
Hypersensitivity Using the Murine Local
Lymph Node Assay (LLNA)
----------------------------------------------------------------------------------------------------------------
2-122 ..................... ASTM F719-81 (Reapproved 2007)1 Standard Contact person and
Practice for Testing Biomaterials in Relevant guidance
Rabbits for Primary Skin Irritation
----------------------------------------------------------------------------------------------------------------
2-124 ..................... ASTM F750-87 (Reapproved 2007)1 Standard Extent of recognition,
Practice for Evaluating Material Extracts Relevant guidance and
by Systemic Injection in the Mouse Contact person
----------------------------------------------------------------------------------------------------------------
2-125 ..................... ASTM F749-98 (Reapproved 2007)1 Standard Extent of recognition,
Practice for Evaluating Material Extracts Relevant guidance and
by Intracutaneous Injection in the Rabbit Contact person
----------------------------------------------------------------------------------------------------------------
2-126 ..................... ASTM F748-06 Standard Practice for Extent of recognition,
Selecting Generic Biological Test Methods Relevant guidance and
for Materials and Devices Contact person
----------------------------------------------------------------------------------------------------------------
2-128 2-147 USP 32-NF26 Biological Tests <87> 2009 Withdrawn and replaced
Biological Reactivity Test, In Vitro-- with newer version
Direct Contact Test
----------------------------------------------------------------------------------------------------------------
2-129 2-148 USP 32-NF26 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Test, In Vitro-- with newer version
Elution Test
----------------------------------------------------------------------------------------------------------------
2-130 2-149 USP 32-NF26 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Tests, In Vivo with newer version
Procedure--Preparation of Sample
----------------------------------------------------------------------------------------------------------------
2-131 2-150 USP 32-NF26 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Test, In Vivo, with newer version
Classification of Plastics--
Intracutaneous Test
----------------------------------------------------------------------------------------------------------------
2-132 2-151 USP 32-NF26 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Tests, In Vivo, with newer version
Classification of Plastics--Systemic
Injection Test
----------------------------------------------------------------------------------------------------------------
2-133 ..................... ASTM F1408-97 (Reapproved 2008) Standard Contact person
Practice for Subcutaneous Screening Test
for Implant Materials
----------------------------------------------------------------------------------------------------------------
2-134 ..................... ASTM F2065-00 (2006) Standard Practice for Contact person
Testing for Alternative Pathway
Complement Activation in Serum by Solid
Materials
----------------------------------------------------------------------------------------------------------------
2-135 ..................... AAMI/ANSI/ISO 10993-12:2007 Biological Extent of recognition,
Evaluation of Medical Devices--Part 12: Relevant guidance and
Sample Preparation and Reference Contact person
Materials
----------------------------------------------------------------------------------------------------------------
C. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-69 4-178 ISO 6872:2008 Dentistry--Ceramic Materials Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
4-73 4-179 ISO 7405: 2008 Dentistry--Evaluation of Withdrawn and replaced
Biocompatibility of Medical Devices Used with newer version
in Dentistry
----------------------------------------------------------------------------------------------------------------
4-175 ..................... ANSI ASA S3.46-1997 (R 2007) Methods of Reaffirmation
Measurement of Real-Ear Performance
Characteristics of Hearing Aids
----------------------------------------------------------------------------------------------------------------
D. General
----------------------------------------------------------------------------------------------------------------
[[Page 46207]]
5-12 5-47 ISO 10012:2003 Measurement Management Withdrawn and replaced
Systems--Requirements for Measurement with newer version
Processes and Measuring Equipment
----------------------------------------------------------------------------------------------------------------
5-15 5-48 ANSI/ASQ Z1.9-2008 Sampling Procedures and Withdrawn and replaced
Tables for Inspection by Variables for with newer version
Percent Nonconforming
----------------------------------------------------------------------------------------------------------------
5-27 ..................... IEC 60601-1-1 Ed. 2.0 2000 Medical Title
Electrical Equipment--Part 1-1: General
Requirements for Safety--Collateral
Standard: Safety requirements for Medical
Electrical Systems
----------------------------------------------------------------------------------------------------------------
5-36 ..................... ISO/TR 16142:2006 Medical Devices-- Title
Guidance on the Selection of Standards in
Support of Recognized Essential
Principles of Safety and Performance of
Medical Devices
----------------------------------------------------------------------------------------------------------------
5-41 ..................... IEC 60601-1-4 (2000) Consol. Ed. 1.1 Title
Medical Electrical Equipment--Part 1-4:
General Requirements for Safety--
Collateral Standard: Programmable
Electrical Medical Systems
----------------------------------------------------------------------------------------------------------------
5-44 5-49 IEC 60601-1-8, Ed. 1 Medical Electrical Withdrawn and re-
Equipment--Part 1-8: General Requirements recognized previous
for Safety--Collateral Standard: Alarm version
Systems--Requirements, Tests and
Guidelines--General Requirements and
Guidelines for Alarm Systems in Medical
Equipment
----------------------------------------------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-63 6-216 ISO 8536-7:2009 Infusion Equipment for Withdrawn and replaced
Medical Use--Part 7: Caps Made of with newer version
Aluminum-plastics Combinations for
Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-112 ..................... ANSI/AAMI PB70:2003 Liquid Barrier Contact person
Performance and Classification of
Protective Apparel and Drapes Intended
for Use in Health Care Facilities
----------------------------------------------------------------------------------------------------------------
6-118 ..................... ASTM F2196-02 Standard Specification for CFR citation and
Circulating Liquid and Forced Air Patient product code
Temperature Management Devices
----------------------------------------------------------------------------------------------------------------
6-144 ..................... ASTM D5712--051 Standard Test Method for Title and Contact
Analysis of Aqueous Extractable Protein person
in Natural Rubber and Its Products Using
the Modified Lowry Method
----------------------------------------------------------------------------------------------------------------
6-145 ..................... ASTM D3578-051 Standard Specification for Title and Contact
Rubber Examination Gloves person
----------------------------------------------------------------------------------------------------------------
6-147 ..................... ASTM D6978-05 Standard Practice for Contact person and
Assessment of Resistance of Medical Relevant guidance
Gloves to Permeation by Chemotherapy
Drugs
----------------------------------------------------------------------------------------------------------------
6-149 ..................... ASTM D7160-05 Standard Practice for Contact person
Determination of Expiration Dating for
Medical Gloves
----------------------------------------------------------------------------------------------------------------
6-150 ..................... ASTM D7161-05 Standard Practice for Contact person
Determination of Real Time Expiration
Dating of Mature Medical Gloves Stored
Under Typical Warehouse Conditions
----------------------------------------------------------------------------------------------------------------
6-165 ..................... ASTM D6977-041 Standard Specification for Title and Contact
Polychloroprene Examination Gloves for person
Medical Application
----------------------------------------------------------------------------------------------------------------
6-167 ..................... ASTM D6319-00a (Reapproved 2005)1 Standard Title and Contact
Specification for Nitrile Examination person
Gloves for Medical Application
----------------------------------------------------------------------------------------------------------------
6-168 ..................... ASTM D3577-091 Standard Specification for Withdrawn and replaced
Rubber Surgical Gloves with newer version
----------------------------------------------------------------------------------------------------------------
6-175 ..................... ASTM D5151-06 Standard Test Method for Contact person
Detection of Holes in Medical Gloves
----------------------------------------------------------------------------------------------------------------
6-178 ..................... ASTM D6124-06 Standard Test Method for Contact person
Residual Powder on Medical Gloves
----------------------------------------------------------------------------------------------------------------
6-183 ..................... ASTM D5250-061 Standard Specification for Title and Contact
Poly(vinyl chloride) Gloves for Medical person
Application
----------------------------------------------------------------------------------------------------------------
6-186 6-217 ASTM F1670-08 Standard Test Method for Withdrawn and replaced
Resistance of Materials Used in with newer version
Protective Clothing to Penetration by
Synthetic Blood
----------------------------------------------------------------------------------------------------------------
[[Page 46208]]
6-205 6-218 USP 32:2009 Nonabsorbable Surgical Suture Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
6-206 6-219 USP 32<11>:2009 Sterile Sodium Chloride Withdrawn and replaced
for Irrigation with newer version
----------------------------------------------------------------------------------------------------------------
6-207 6-220 USP 32:2009 Absorbable Surgical Suture Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
6-208 6-221 USP 32<881>:2009 Tensile Strength Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
6-209 6-222 USP 32<861>:2009 Sutures--Diameter Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
6-210 6-223 USP 32<871>:2009 Sutures Needle Attachment Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
6-211 6-224 USP 32<11>:2009 Sterile Water for Withdrawn and replaced
Irrigation with newer version
----------------------------------------------------------------------------------------------------------------
6-212 6-225 USP 32<11>:2009 Heparin Lock Flush Withdrawn and replaced
Solution with newer version
----------------------------------------------------------------------------------------------------------------
6-213 6-226 USP 32<11>:2009 Sodium Chloride Injection Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
F. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-156 7-195 CLSI M02-A10, Performance Standards for Withdrawn and replaced
Antimicrobial Disk Susceptibility Tests with newer version
----------------------------------------------------------------------------------------------------------------
7-158 7-196 CLSI M07-A8, Methods for Dilution Withdrawn and replaced
Antimicrobial Susceptibility Tests for with newer version
Bacteria that Grow Aerobically
----------------------------------------------------------------------------------------------------------------
7-160 7-197 CLSI M35-A2, Abbreviated Identification of Withdrawn and replaced
Bacteria and Yeast with newer version
----------------------------------------------------------------------------------------------------------------
7-78 7-198 CLSI M23-A3, Development of In Vitro Withdrawn and replaced
Susceptibility Testing Criteria and with newer version
Quality Control Parameters
----------------------------------------------------------------------------------------------------------------
7-177 7-199 CLSI M100-S19 Performance Standards for Withdrawn and replaced
Antimicrobial Susceptibility Testing with newer version
----------------------------------------------------------------------------------------------------------------
7-161 7-200 CLSI M48-A, Laboratory Detection and Withdrawn and replaced
Identification of Mycobacteria with newer version
----------------------------------------------------------------------------------------------------------------
7-102 ..................... NCCLS H1-A5, Tubes and Additives for Contact Person
Venous Blood Specimen Collection
----------------------------------------------------------------------------------------------------------------
7-101 ..................... NCCLS H51-A, Assays of vonWillebrand Contact Person
Factor Antigen and Ristocetin Cofactor
Activity
----------------------------------------------------------------------------------------------------------------
7-165 ..................... CLSI H20-A2, Reference Leukocyte (WBC) Contact Person
Differential Count (Proportional) and
Evaluation of Instrumental Methods
----------------------------------------------------------------------------------------------------------------
7-103 7-201 CLSI H3-A6, Procedures for the Collection Withdrawn and replaced
of Diagnostic Blood Specimens by with newer version
Venipuncture
----------------------------------------------------------------------------------------------------------------
7-81 7-202 CLSI C28-A3 Defining, Establishing, and Withdrawn and replaced
Verifying Reference Intervals in the with newer version
Clinical Laboratory
----------------------------------------------------------------------------------------------------------------
7-144 7-203 CLSI H04-A6, Procedures and Devices for Withdrawn and replaced
the Collection of Diagnostic Capillary with newer version
Blood Specimens
----------------------------------------------------------------------------------------------------------------
G. Materials
----------------------------------------------------------------------------------------------------------------
8-32 8-163 ASTM F1586-08 Standard Specification for Withdrawn and replaced
Wrought Nitrogen Strengthened 21 Chromium- with newer version
10Nickel-3Manganese-2.5Molybdenum
Stainless Steel Bar for Surgical Implants
(UNS S31675)
----------------------------------------------------------------------------------------------------------------
[[Page 46209]]
8-44 8-164 ASTM F136-081 Standard Specification for Withdrawn and replaced
Wrought Titanium-6 Aluminum-4 Vanadium with newer version
ELI (Extra Low Interstitial) Alloy for
Surgical Implant Applications (UNS
R56401)
----------------------------------------------------------------------------------------------------------------
8-49 8-165 ASTM F1058-08 Standard Specification for Withdrawn and replaced
Wrought 40Cobalt-20Chromium-16Iron- with newer version
15Nickel-7Molybdenum Alloy Wire and Strip
for Surgical Implant Applications (UNS
R30003 and UNS R30008)
----------------------------------------------------------------------------------------------------------------
8-50 8-166 ASTM F1091-08 Standard Specification for Withdrawn and replaced
Wrought Cobalt-20 Chromium-15 Tungsten-10 with newer version
Nickel Alloy Surgical Fixation Wire (UNS
R30605)
----------------------------------------------------------------------------------------------------------------
8-52 8-167 ASTM F1350-08 Standard Specification for Withdrawn and replaced
Wrought 18 Chromium-14 Nickel-2.5 with newer version
Molybdenum Stainless Steel Surgical
Fixation Wire (UNS S31673)
----------------------------------------------------------------------------------------------------------------
8-53 8-168 ASTM F1472-081 Standard Specification for Withdrawn and replaced
Wrought Titanium -6Aluminum -4Vanadium with newer version
Alloy for Surgical Implant Applications
(UNS R56400)
----------------------------------------------------------------------------------------------------------------
8-76 8-169 ASTM F138-08 Standard Specification for Withdrawn and replaced
Wrought 18 Chromium-14 Nickel-2.5 with newer version
Molybdenum Stainless Steel Bar and Wire
for Surgical Implants (UNS S31673)
----------------------------------------------------------------------------------------------------------------
8-79 8-170 ASTM F961-08 Standard Specification for Withdrawn and replaced
35Cobalt-35 Nickel-20 Chromium-10 with newer version
Molybdenum Alloy Forgings for Surgical
Implants (UNS R30035)
----------------------------------------------------------------------------------------------------------------
8-81 8-171 ASTM F1609-08 Standard Specification for Withdrawn and replaced
Calcium Phosphate Coatings for with newer version
Implantable Materials
----------------------------------------------------------------------------------------------------------------
8-86 8-172 ASTM F1926/F1926M-08 Standard Test Method Withdrawn and replaced
for Evaluation of the Environmental with newer version
Stability of Calcium Phosphate Granules,
Fabricated Forms, and Coatings
----------------------------------------------------------------------------------------------------------------
8-94 8-173 ASTM F601-03 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Fluorescent Penetrant with newer version
Inspection of Metallic Surgical Implants
----------------------------------------------------------------------------------------------------------------
8-95 8-174 ASTM F629-02 (Reapproved 2007)1 Standard Withdrawn and replaced
Practice for Radiography of Cast Metallic with newer version
Surgical Implants
----------------------------------------------------------------------------------------------------------------
8-110 8-175 ASTM F1377-08 Standard Specification for Withdrawn and replaced
Cobalt-28 Chromium-6 Molybdenum Powder with newer version
for Coating of Orthopedic Implants (UNS
R30075)
----------------------------------------------------------------------------------------------------------------
8-118 8-176 ASTM F2503-08 Standard Practice for Withdrawn and replaced
Marking Medical Devices and Other Items with newer version
for Safety in the Magnetic Resonance
Environment
----------------------------------------------------------------------------------------------------------------
8-133 8-177 ASTM F2129-08 Standard Test Method for Withdrawn and replaced
Conducting Cyclic Potentiodynamic with newer version
Polarization Measurements to Determine
the Corrosion Susceptibility of Small
Implant Devices
----------------------------------------------------------------------------------------------------------------
8-143 8-178 ASTM F648-071 Standard Specification for Withdrawn and replaced
Ultra-High-Molecular-Weight Polyethylene with newer version
Powder and Fabricated Form for Surgical
Implants
----------------------------------------------------------------------------------------------------------------
8-144 8-179 ASTM F754-08 Standard Specification for Withdrawn and replaced
Implantable Polytetrafluoroethylene with newer version
(PTFE) Sheet, Tube, and Rod Shapes
Fabricated from Granular Molding Powders
----------------------------------------------------------------------------------------------------------------
8-146 8-180 ASTM F2066-08 Standard Specification for Withdrawn and replaced
Wrought Titanium-15 Molybdenum Alloy for with newer version
Surgical Implant Applications (UNS
R58150)
----------------------------------------------------------------------------------------------------------------
8-148 8-181 ASTM F899-09 Standard Specification for Withdrawn and replaced
Wrought Stainless Steels for Surgical with newer version
Instruments
----------------------------------------------------------------------------------------------------------------
8-152 8-182 ASTM F1537-08 Standard Specification for Withdrawn and replaced
Wrought Cobalt-28-Chromium-6-Molybdenum with newer version
Alloys for Surgical Implants (UNS R31537,
UNS R31538, and UNS R31539)
----------------------------------------------------------------------------------------------------------------
8-160 8-183 ASTM F560-08 Standard Specification for Withdrawn and replaced
Unalloyed Tantalum for Surgical Implant with newer version
Applications (UNS R05200, UNS R05400)
----------------------------------------------------------------------------------------------------------------
[[Page 46210]]
8-161 8-184 ASTM F2516-072 Standard Test Method for Withdrawn and replaced
Tension Testing of Nickel-Titanium with newer version
Superelastic Materials
----------------------------------------------------------------------------------------------------------------
8-162 8-185 ASTM F451-08 Standard Specification for Withdrawn and replaced
Acrylic Bone Cement with newer version
----------------------------------------------------------------------------------------------------------------
H. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-34 ..................... ISO 4074:2002/Cor.1:2003(E):, Natural Relevant guidance
Latex Rubber Condoms--Requirements and
Test Methods, Technical Corrigendum 1
----------------------------------------------------------------------------------------------------------------
9-41 9-58 ASTM D6324-08 Standard Test Methods for Withdrawn and replaced
Male Condoms Made from Polyurethane with newer version
----------------------------------------------------------------------------------------------------------------
9-43 ..................... ISO 16038:2005 Rubber condoms--Guidance on Relevant guidance
the Use of ISO 4074 in the Quality
Management of Natural Rubber Latex
Condoms
----------------------------------------------------------------------------------------------------------------
9-56 ..................... ASTM D3492-08 Standard Specification for Relevant guidance
Rubber Contraceptives (Male Condoms)
----------------------------------------------------------------------------------------------------------------
9-57 ..................... ISO 4074:2002/Cor.2:2008(E) Natural Latex Relevant guidance
Rubber Condoms--Requirements and Test
Methods, Technical Corrigendum 2
----------------------------------------------------------------------------------------------------------------
I. Orthopedics
----------------------------------------------------------------------------------------------------------------
11-172 11-211 ASTM F1798-97 (Reapproved 2008) Standard Withdrawn and replaced
Guide for Evaluating the Static and with newer version
Fatigue Properties of Interconnection
Mechanisms and Subassemblies Used in
Spinal Arthrodesis Implants
----------------------------------------------------------------------------------------------------------------
11-178 11-212 ASTM F1440-92 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Cyclic Fatigue Testing of with newer version
Metallic Stemmed Hip Arthroplasty Femoral
Components Without Torsion
----------------------------------------------------------------------------------------------------------------
11-192 11-213 ASTM F1223-08 Standard Test Method for Withdrawn and replaced
Determination of Total Knee Replacement with newer version
Constraint
----------------------------------------------------------------------------------------------------------------
11-198 11-214 ASTM F0382-99 (Reapproved 2008) Standard Withdrawn and replaced
Specification and Test Method for with newer version
Metallic Bone Plates
----------------------------------------------------------------------------------------------------------------
11-204 11-215 ASTM F897-02 (Reapproved 2007) Standard Withdrawn and replaced
Test Method for Measuring Fretting with newer version
Corrosion of Osteosynthesis Plates and
Screws
----------------------------------------------------------------------------------------------------------------
11-205 11-216 ASTM F1264-03 (Reapproved 2007)1 Standard Withdrawn and replaced
Specification and Test Methods for with newer version
Intramedullary Fixation Devices
----------------------------------------------------------------------------------------------------------------
11-209 11-217 ASTM F2083-081 Standard Specification for Withdrawn and replaced
Total Knee Prosthesis with newer version
----------------------------------------------------------------------------------------------------------------
J. Radiology
----------------------------------------------------------------------------------------------------------------
12-17 12-192 NEMA MS 8-2008 Characterization of the Withdrawn and replaced
Specific Absorption Rate for Magnetic with new version
Resonance Imaging Systems
----------------------------------------------------------------------------------------------------------------
12-48 12-193 AIUM AOL 2008 Acoustic Output Labeling Withdrawn and replaced
Standard for Diagnostic Ultrasound with newer version
Equipment Revision 1- A Standard for How
Manufacturers Should Specify Acoustic
Output Data
----------------------------------------------------------------------------------------------------------------
12-58 12-194 ANSI/HPS N43.6-2007 Sealed Radioactive Withdrawn and replaced
Sources--Classification with newer version
----------------------------------------------------------------------------------------------------------------
12-69 12-195 NEMA MS 6-2008 Determination of Signal-to- Withdrawn and replaced
Noise Ratio and Image Uniformity for with newer version
Single-Channel Non-Volume Coils in
Diagnostic MR Imaging
----------------------------------------------------------------------------------------------------------------
12-95 12-196 NEMA MS 2-2008 Determination of Two- Withdrawn and replaced
Dimensional Geometric Distortion in with newer version
Diagnostic Magnetic Resonance Images
----------------------------------------------------------------------------------------------------------------
12-100 ..................... NEMA UD 3-2004 Standard for Real Time Contact person
Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic
Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------
[[Page 46211]]
12-105 ..................... NEMA UD 2-2004 Acoustic Output Measurement Contact person
Standard for Diagnostic Ultrasound
Equipment Version 3
----------------------------------------------------------------------------------------------------------------
12-139 ..................... AIUM AOMS-2004 Acoustic Output Measurement Title and Contact
Standard for Diagnostic Ultrasound person
Equipment
----------------------------------------------------------------------------------------------------------------
12-140 ..................... AIUM RTD1-2004 Standard for Real-Time Title and Contact
Display of Thermal and Mechanical person
Acoustic Output Indices on Diagnostic
Ultrasound Equipment Revision 1
----------------------------------------------------------------------------------------------------------------
12-146 ..................... IEC 60601-2-17 (2004) Medical Electrical Title
Equipment--Part 2-17: Particular
Requirements for the Safety of
Automatically-controlled Brachytherapy
Afterloading Equipment
----------------------------------------------------------------------------------------------------------------
12-147 ..................... IEC 60601-2-5: (2000) Medical Electrical Title
Equipment--Part 2-5: Particular
Requirements for the Safety of Ultrasonic
Physiotherapy Equipment Ed. 2.0
----------------------------------------------------------------------------------------------------------------
12-169 12-197 IEC 60601-2-22 (1995) Medical Electrical Withdrawn and re-
Equipment--Part 2-22: Particular recognized previous
Requirements for Basic Safety and version
Essential Performance of Surgical,
Cosmetic, Therapeutic and Diagnostic
Laser Equipment--Edition 2.0
----------------------------------------------------------------------------------------------------------------
12-178 ..................... IEC 60601-2-45 Ed. 2.0, (2001), Medical Title
electrical equipment--Part 2-45:
Particular requirements for the safety of
mammographic X-ray equipment and
mammographic stereotactic devices
----------------------------------------------------------------------------------------------------------------
12-182 12-198 IEC 60601-2-37 (2004), (2005) Amendment 2, Withdrawn and re-
Medical Electrical Equipment--Part 2-37: recognized previous
Particular Requirements for the Safety of version
Ultrasonic Medical Diagnostic and
Monitoring Equipment
----------------------------------------------------------------------------------------------------------------
12-185 12-199 IEC 60601-1-3: 1994 Medical Electrical Withdrawn and re-
Equipment--Part 1: General Requirements recognize previous
for Safety 3. Collateral Standard: version
General Requirements for Radiation
Protection in Diagnostic X-ray Equipment--
First Edition
----------------------------------------------------------------------------------------------------------------
12-186 12-200 IEC 60601-2-29 (1999) Medical Electrical Withdrawn and re-
Equipment Part 2-29: Particular recognized previous
Requirements for the Safety of version
Radiotherapy Simulators--Second Edition
----------------------------------------------------------------------------------------------------------------
K. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-16 13-29 CLSI LIS01-A2 Specification for Low-Level Withdrawn and replaced
Protocol to Transfer Messages Between with newer version
Clinical Laboratory Instruments and
Computer Systems
----------------------------------------------------------------------------------------------------------------
L. Sterility
----------------------------------------------------------------------------------------------------------------
14-55 ..................... ANSI/AAMI/ISO 14160:1998/(R) 2008 Reaffirmation
Sterilization of Single-use Medical
Devices Incorporating Materials of Animal
Origin--Validation and Routine Control of
Sterilization by Liquid Chemical
Sterilants
----------------------------------------------------------------------------------------------------------------
14-88 ..................... ANSI/AAMI/ ISO 14937:2000 Sterilization of Contact person
Health Care Products--General
Requirements for Characterization of a
Sterilizing Agent and the Development,
Validation, and Routine Control of a
Sterilization Process for Medical
Devices.
----------------------------------------------------------------------------------------------------------------
14-116 ..................... ANSI/AAMI ST72:2002 Bacterial Endotoxins-- Relevant guidance and
Test Methodologies, Routine Monitoring, Extent of recognition
and Alternatives to Batch Testing
----------------------------------------------------------------------------------------------------------------
14-135 ..................... ANSI/AAMI ST63:2002 Sterilization of Relevant Guidance
Health Care Products--Requirements for
the Development, Validation, and Routine
Control of an Industrial Sterilization
Process for Medical Devices--Dry Heat
----------------------------------------------------------------------------------------------------------------
14-164 ..................... ANSI/AAMI ST81:2004 Sterilization of Contact Person
Medical Devices--Information to be
Provided by the Manufacturer for the
Processing of Resterilizable Medical
Devices
----------------------------------------------------------------------------------------------------------------
14-195 ..................... ANSI/AAMI/ISO 11140-1:2005 Sterilization Relevant Guidance,
of Health Care Products--Chemical Extent of Recognition
Indicators--Part 1: General Requirements and Contact person
----------------------------------------------------------------------------------------------------------------
[[Page 46212]]
14-220 14-263 ANSI/AAMI ST79:2006/A1:2008 Comprehensive Withdrawn and replaced
Guide to Steam Sterilization and with newer version
Sterility Assurance in Health Care
Facilities
----------------------------------------------------------------------------------------------------------------
14-223 ..................... ANSI/AAMI/ISO 11138-1:2006 Sterilization Relevant Guidance
of Health Care Products--Biological
Indicators--Part 1: General Requirements
----------------------------------------------------------------------------------------------------------------
14-224 ..................... ANSI/AAMI/ISO 11137-1:2006 Sterilization Relevant Guidance
of Health Care Products--Radiation--Part
1: Requirements for Development,
Validation, and Routine Control of a
Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------
14-225 ..................... ANSI/AAMI/ISO 11137-2:2006 Sterilization Relevant Guidance
of Health Care Products--Radiation--Part
2: Establishing the Sterilization Dose
----------------------------------------------------------------------------------------------------------------
14-226 ..................... ANSI/AAMI/ISO 11137-3:2006 Sterilization Relevant Guidance
of Health Care Products--Radiation--Part
3: Guidance on Dosimetric Aspects
----------------------------------------------------------------------------------------------------------------
14-228 ..................... ANSI/AAMI/ISO 11135-1:2007 Sterilization Relevant Guidance
of Health Care Products--Ethylene oxide--
Part 1: Requirements for Development,
Validation, and Routine Control of a
Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------
14-261 ..................... ANSI/AAMI/ISO 17665-1:2006 Sterilization Relevant Guidance
of Health Care Products--Moist Heat--Part
1: Requirements for the Development,
Validation, and Routine Control of a
Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------
14-119 ..................... ANSI/AAMI ST55:2003/(R)2008 Table-top Reaffirmation
Steam Sterilizers
----------------------------------------------------------------------------------------------------------------
14-71 14-264 ANSI/AAMI ST8:2008 Hospital Steam Withdrawn and replaced
Sterilizers with newer version
----------------------------------------------------------------------------------------------------------------
14-249 14-265 USP 32:2009 <61> Microbiological Withdrawn and replaced
Examination of Nonsterile Products: with newer version
Microbial Enumeration Tests
----------------------------------------------------------------------------------------------------------------
14-250 14-266 USP 32:2009 <71> Sterility Tests Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
14-251 14-267 USP 32:2009 <85> Bacterial Endotoxins Test Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
14-252 14-268 USP 32:2009 <151> Pyrogen Test (USP Rabbit Withdrawn and replaced
Test) with newer version
----------------------------------------------------------------------------------------------------------------
14-253 14-269 USP 32:2009 <161> Transfusion and Infusion Withdrawn and replaced
Assemblies and Similar Medical Devices with newer version
----------------------------------------------------------------------------------------------------------------
14-254 14-270 USP 32:2009 Biological Indicator for Steam Withdrawn and replaced
Sterilization--Self Contained with newer version
----------------------------------------------------------------------------------------------------------------
14-246 14-271 USP 32:2009 Biological Indicator for Dry- Withdrawn and replaced
Heat Sterilization, Paper Carrier with newer version
----------------------------------------------------------------------------------------------------------------
14-247 14-272 USP 32:2009 Biological Indicator for Withdrawn and replaced
Ethylene Oxide Sterilization, Paper with newer version
Carrier
----------------------------------------------------------------------------------------------------------------
14-248 14-273 USP 32:2009 Biological Indicator for Steam Withdrawn and replaced
Sterilization, Paper Carrier with newer version
----------------------------------------------------------------------------------------------------------------
14-238 ..................... ANSI/AAMI/ISO 11140-5:2007 Sterilization Contact person and
of Health Care Products--Chemical Relevant guidance
Indicators--Part 5: Class 2 Indicators
for Bowie and Dick-type Air Removal Tests
----------------------------------------------------------------------------------------------------------------
14-171 14-274 ANSI/AAMI/ISO 15882:2008 Chemical Withdrawn and replaced
Indicators--Guidance on the Selection, with newer version
Use, and Interpretation of Results
----------------------------------------------------------------------------------------------------------------
14-49 14-275 ANSI/AAMI ST41:2008 Ethylene oxide Withdrawn and replaced
Sterilization in Health Care Facilities: with newer version
Safety and Effectiveness
----------------------------------------------------------------------------------------------------------------
14-136 ..................... ANSI/AAMI ST67:2003/(R) 2008 Sterilization Reaffirmation and
of Health Care Products--Requirements for Relevant guidance
Products Labeled ``STERILE''
----------------------------------------------------------------------------------------------------------------
[[Page 46213]]
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: 022.
Table 3.
----------------------------------------------------------------------------------------------------------------
Recognition No. Title of Standard Reference No. & Date
----------------------------------------------------------------------------------------------------------------
A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-152 Biological Evaluation of Medical Devices--Part 10: Tests for ISO 10993 10:2002/
Irritation and Delayed-type Hypersensitivity Amendment 1 Amd.1:2006(E)
----------------------------------------------------------------------------------------------------------------
B. General
----------------------------------------------------------------------------------------------------------------
5-46 Sampling Procedures for Inspection by Attributes--Part 1: ISO 2859-1:1999/Cor 1:2001
Sampling Schemes Indexed by Acceptance Quality Limit (AQL)
for Lot-by-lot Inspection
----------------------------------------------------------------------------------------------------------------
5-50 Medical Devices--Application of Usability Engineering to IEC 62366:2007
Medical Devices
----------------------------------------------------------------------------------------------------------------
C. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-204 Reference Method for Broth Dilution Antifungal CLSI M27-A3
Susceptibility Testing of Yeasts
----------------------------------------------------------------------------------------------------------------
D. Materials
----------------------------------------------------------------------------------------------------------------
8-186 Standard Guide for Assessment of the Ultra High Molecular ASTM F 2759--09
Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal
Devices
----------------------------------------------------------------------------------------------------------------
8-187 Implants for Surgery--Hydroxyapatite--Part 1: Ceramic ISO 13779-1:2008(E)
Hydroxyapatite
----------------------------------------------------------------------------------------------------------------
8-188 Implants for Surgery--Hydroxyapatite--Part 2: Coatings of ISO 13779-2:2008(E)
Hydroxyapatite
----------------------------------------------------------------------------------------------------------------
E. Neurology
----------------------------------------------------------------------------------------------------------------
17-8 Implants for Surgery--Active Implantable Medical Devices ISO 14708-3 2008-11-15
Part 3: Implantable Neurostimulators (Neurology)
----------------------------------------------------------------------------------------------------------------
F. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-59 Hemodialysis Systems ANSI/AAMI RD5:2003/(R)
2008
----------------------------------------------------------------------------------------------------------------
G. Orthopedics
----------------------------------------------------------------------------------------------------------------
11-218 Implants for surgery--Wear of Total Knee-joint Prostheses-- ISO 14243-3:2004 Technical
Part 3: Loading and Displacement Parameters for Wear- Corrigendum 1
testing Machines with Displacement Control and
Corresponding Environmental Conditions for Test
----------------------------------------------------------------------------------------------------------------
H. Sterility
----------------------------------------------------------------------------------------------------------------
14-276 Sterilization of Health Care Products--Moist Heat--Part 2: ISO/TS 17665-2:2009
Guidance on the Application of ISO 17665-1
----------------------------------------------------------------------------------------------------------------
14-277 Microbiological Examination of Nonsterile Products: Tests USP32:2009 <62>
for Specified Microorganisms
----------------------------------------------------------------------------------------------------------------
14-278 Biological Evaluation of Medical Devices--Part 7: Ethylene ANSI/AAMI/ISO 10993-7:2008
Oxide Sterilization Residuals
----------------------------------------------------------------------------------------------------------------
I. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-14 Standard Guide for Interpreting Images of Polymeric Tissue ASTM F2603-06
Scaffolds
----------------------------------------------------------------------------------------------------------------
15-15 Standard Test Method for Determining the Chemical ASTM F2259-03 (Reapproved
Composition and Sequence in Alginate by Proton Nuclear 2008)
Magnetic Resonance (1H NMR) Spectroscopy
----------------------------------------------------------------------------------------------------------------
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 document 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.
[[Page 46214]]
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 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 document announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 022'' 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. Two copies of any mailed comments are to be submitted,
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: 022. These modifications
to the list or recognized standards are effective upon publication of
this document in the Federal Register.
Dated: August 26, 2009.
Catherine M. Cook,
Associate Director for Regulation and Policy.
[FR Doc. E9-21609 Filed 9-4-09; 8:45 am]
BILLING CODE 4160-01-S