[Federal Register Volume 74, Number 51 (Wednesday, March 18, 2009)]
[Notices]
[Pages 11586-11593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5858]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 021
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 021'' (Recognition List Number: 021), 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: 021'' 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 240-276-3151. 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: 021
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, 7520
Standish Place, Rockville, MD 20855, 240-276-8714.
[[Page 11587]]
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.
Modifications to the initial list of recognized standards, as
published in the Federal Register, are identified in table 1.
Table 1--Federal Register Citation
------------------------------------------------------------------------
------------------------------------------------------------------------
October 16, 1998 (63 FR 55617) May 27, 2005 (70 FR 30756)
------------------------------------------------------------------------
July 12, 1999 (64 FR 37546) November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
November 15, 2000 (65 FR 69022) March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
May 7, 2001 (66 FR 23032) June 23, 2006 (71 FR 36121)
------------------------------------------------------------------------
January 14, 2002 (67 FR 1774) November 3, 2006 (71 FR 64718)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893) May 21, 2007 (72 FR 28500)
------------------------------------------------------------------------
April 28, 2003 (68 FR 22391) September 12, 2007 (72 FR 52142)
------------------------------------------------------------------------
March 8, 2004 (69 FR 10712) December 19, 2007 (72 FR 71924)
------------------------------------------------------------------------
June 18, 2004 (69 FR 34176) September 9, 2008 (73 FR 52358)
------------------------------------------------------------------------
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: 021
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: 021'' 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
----------------------------------------------------------------------------------------------------------------
1-49 ..................... ASTM F 1981-99 Standard Specification for Withdrawn
Suction Catheters for use in the
Respiratory Tract
----------------------------------------------------------------------------------------------------------------
1-63 1-77 CGA V-1:2005 Standard for Compressed Gas Withdrawn and replaced
Cylinder Valve Outlet and Inlet with newer version
Connection
----------------------------------------------------------------------------------------------------------------
1-64 1-78 ASME PVHO-1-2007 Safety Standard for Withdrawn and replaced
Pressure Vessels for Human Occupancy with newer version
----------------------------------------------------------------------------------------------------------------
[[Page 11588]]
1-71 ..................... ISO 10651-5:2006 Lung Ventilators for Withdrawn duplicate
Medical Use--Particular requirements for
Basic Safety and Essential Performance--
Part 5: Gas-powered Emergency
Resuscitators
----------------------------------------------------------------------------------------------------------------
1-74 ..................... ISO 5360:2006 Anaesthetic Vaporizers-- Contact person
Agent Specific Filling Systems
----------------------------------------------------------------------------------------------------------------
1-76 1-79 ISO 26825:2008 (E) Anaesthetic And Withdrawn and replaced
Respiratory Equipment--User-Applied with newer version
Labels For Syringes Containing Drugs Used
During Anaesthesia--Colours, Design and
Performance
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-71 2-133 ASTM F1408-97 (2008) Standard Practice for Withdrawn and replaced
Subcutaneous Screening Test for Implant with newer version
Materials
----------------------------------------------------------------------------------------------------------------
2-73 2-134 ASTM F2065-00(2006) Standard Practice for Withdrawn and replaced
Testing for Alternative Pathway with newer version
Complement Activation in Serum by Solid
Materials
----------------------------------------------------------------------------------------------------------------
2-87 ..................... AAMI/ANSI/ISO 10993-10:2002 Biological Extent of Recognition,
Evaluation of Medical Devices--Part 10: Relevant Guidance,
Tests for Irritation and Delayed-Type and Contact Person
Hypersensitivity
----------------------------------------------------------------------------------------------------------------
2-88 2-135 AAMI/ANSI/ISO 10993-12:2007 Biological Withdrawn and replaced
Evaluation of Medical Devices--Part 12: with newer version
Sample Preparation and Reference
Materials
----------------------------------------------------------------------------------------------------------------
2-127 ..................... ANSI/AAMI BE 78:2002/A1:2006 Biological Withdrawn
Evaluation of Medical Devices--Part 10:
Tests For Irritation and Delayed-Type
Hypersensitivity--Amendment 1
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular/Neurology
----------------------------------------------------------------------------------------------------------------
3-67 ..................... ASTM F2129-06 Standard Test Method for Offices, Devices
Conducting Cyclic Potentiodynamic Affected, Relevant
Polarization Measurements to Determine Guidance, CFR
the Corrosion Susceptibility of Small Citation and Product
Implant Devices Codes, Contact Person
----------------------------------------------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-29 ..................... IEC 60601-2-19 1996-10: Amendment 1-- Relevant guidance
Medical Electrical Equipment Part 2:
Particular Requirements for Safety of
Baby Incubators
----------------------------------------------------------------------------------------------------------------
6-32 ..................... IEC 60601-2-20 1996-10: Amendment 1-- Relevant guidance
Medical Electrical Equipment Part 2:
Particular Requirements for the Safety Of
Transport Incubators
----------------------------------------------------------------------------------------------------------------
6-62 ..................... ISO 8536-6:1995 Infusion Equipment for Relevant guidance
Medical Use--Part 6: Freeze Drying
Closures for Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-63 ..................... ISO 8536-7-1999: Infusion Equipment for Relevant guidance
Medical Use--Part 7: Caps Made of
Aluminum-Plastics Combinations For
Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-64 ..................... ISO 8536-3-1999, Infusion Equipment for Relevant guidance
Medical Use--Part 3: Aluminum Caps for
Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-119 ..................... ANSI/AAMI BF7:1989/(R)2002/(R)2007 Blood Reaffirmation 2007,
Transfusion Micro-Filters Title, SDO, Date of
standard, Relevant
guidance
----------------------------------------------------------------------------------------------------------------
6-122 ..................... ISO 8536-5-2004:, Infusion Equipment for Relevant guidance
Medical Use--Part 5: Burette Infusion
Sets for Single Use, Gravity Feed
----------------------------------------------------------------------------------------------------------------
6-127 ..................... ISO 1135-4-2004: Transfusion Equipment for Relevant guidance
Medical Use--Part 4: Transfusion Sets for
Single Use
----------------------------------------------------------------------------------------------------------------
6-142 ..................... ANSI/AAMI II36:2004 Medical Electrical Title, Relevant
Equipment--Part 2: Particular guidance
Requirements for Safety of Baby
Incubators
----------------------------------------------------------------------------------------------------------------
6-143 ..................... ANSI/AAMI II51:2004, Medical Electrical Title, Relevant
Equipment--Part 2: Particular guidance
Requirements for Safety of Transport
Incubators
----------------------------------------------------------------------------------------------------------------
[[Page 11589]]
6-172 ..................... ISO 8536-1:2006 Infusion Equipment for Relevant guidance
Medical Use--Part 1: Infusion Glass
Bottles
----------------------------------------------------------------------------------------------------------------
6-173 ..................... ISO 8536-2:2001 Corrigendum 1:2003, Relevant guidance
Infusion Equipment for Medical Use--Part
2: Closures for Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-182 ..................... IEC 60601-2-38 1996/Amendment 1:1999, Relevant guidance
Medical Electrical Equipment--Part 2-38:
Particular Requirements for the Safety of
Electrically Operated Hospital Beds
----------------------------------------------------------------------------------------------------------------
6-201 ..................... ISO 8536-4:2007 Infusion Equipment for Relevant guidance
Medical Use--Part 4: Infusion Sets for
Single Use, Gravity Feed
----------------------------------------------------------------------------------------------------------------
6-215 ..................... ASTM F2132-01(2008)E1 Standard Title
Specification for Puncture Resistance of
Materials Used in Containers for
Discarded Medical Needles and Other
Sharps
----------------------------------------------------------------------------------------------------------------
E. IVD
----------------------------------------------------------------------------------------------------------------
7-138 7-169 CLSI M27-A3 Reference Method for Broth Withdrawn and replaced
Dilution Antifungal Susceptibility with newer version
Testing of Yeasts
----------------------------------------------------------------------------------------------------------------
7-54 ..................... CLSI D12-A2, Immunoprecipitin Analyses: Title
Procedures for Evaluating the Performance
of Materials--Second Edition; Approved
Guideline
----------------------------------------------------------------------------------------------------------------
7-71 ..................... CLSI H15-A3, Reference and Selected Contact person
Procedures for the Quantitative
Determination of Hemoglobin in Blood;
Approved Standard--Third Edition
----------------------------------------------------------------------------------------------------------------
7-145 ..................... CLSI H42-A2, Enumeration of Contact person
Immunologically Defined Cell Populations
by Flow Cytometry.
----------------------------------------------------------------------------------------------------------------
7-73 7-170 CLSI ILA21-A2 Clinical Evaluation of Withdrawn and replaced
Immunoassays with newer version
----------------------------------------------------------------------------------------------------------------
7-130 ..................... CLSI H20-A2, Reference Leucocyte Contact person
Differential Count (Proportional) and
Evaluation of Instrumental Methods;
Approved Standard--Second Edition
----------------------------------------------------------------------------------------------------------------
7-164 ..................... CLSI GP 28-A Microwave Device Use in the Contact person
Histology Laboratory; Approved Guideline
----------------------------------------------------------------------------------------------------------------
7-168 7-171 CLSI M38-A2 Reference Method for Broth Withdrawn and replaced
Dilution Antifungal Susceptibility with newer version
Testing of Filamentous Fungi
----------------------------------------------------------------------------------------------------------------
F. Neurology
----------------------------------------------------------------------------------------------------------------
3-3 17-1 AAMI NS28:1988/(R) 2006 Intracranial Transferred, Date of
Pressure Monitoring Devices standard, Extent of
recognition, Relevant
guidance
----------------------------------------------------------------------------------------------------------------
3-32 17-2 ASTM F1542-94(2000) Standard Specification Transferred, Offices,
for the Requirements and Disclosure of Type of standard,
Self-Closing Aneurysm Clips Extent of
recognition, Relevant
guidance, Contact
person
----------------------------------------------------------------------------------------------------------------
3-33 17-3 ISO 7197:2006 Neurosurgical implants-- Transferred--Withdrawn
Sterile, Single-use hydrocephalus Shunts and replaced with
and Components newer version
----------------------------------------------------------------------------------------------------------------
3-39 17-4 ASTM F647-94(2006) Standard Practice for Transferred--Withdrawn
Evaluating and Specifying Implantable and replaced with
Shunt Assemblies for Neurosurgical newer version
Application
----------------------------------------------------------------------------------------------------------------
3-60 17-5 IEC 60601-2-10 1987/Amendment 1 2001 Transferred, Title
Medical Electrical Equipment--Part 2-10: change, Date of
Particular Requirements for the Safety of standard, Relevant
Nerve and Muscle Stimulators guidance, Contact
person
----------------------------------------------------------------------------------------------------------------
3-67 17-6 ASTM F2129-06 Standard Test Method for Offices, Devices
Conducting Cyclic Potentiodynamic affected, Type of
Polarization Measurements to Determine Standard, Product
the Corrosion Susceptibility of Small code, Relevant
Implant Devices guidance, Contact
person
----------------------------------------------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
[[Page 11590]]
9-30 9-55 ANSI/ AAMI RD62:2006 Water Treatment Withdrawn and replaced
Equipment for Hemodialysis Applications with newer version
----------------------------------------------------------------------------------------------------------------
9-32 9-56 ASTM D3492-08 Standard Specification for Withdrawn and replaced
Rubber Contraceptives (Male Condoms) with newer version
----------------------------------------------------------------------------------------------------------------
9-34 ..................... ISO 4074:2002/Cor.1:2003(E): Natural Latex Extent of recognition,
Rubber Condoms--Requirements and Test Product codes,
Methods, Technical Corrigendum 1 Relevant guidance
----------------------------------------------------------------------------------------------------------------
H. Radiology
----------------------------------------------------------------------------------------------------------------
12-48 ..................... AIUM AOL, Acoustic Output Labeling Relevant guidance
Standard for Diagnostic Ultrasound
Equipment: A Standard for How
Manufacturers Should Specify Acoustic
Output Data
----------------------------------------------------------------------------------------------------------------
12-55 12-186 IEC 60601-2-29 (2008) Medical Electrical Withdrawn and replaced
Equipment--Part 2-29: Particular with newer version
Requirements for the Basic Safety and
Essential Performance of Radiotherapy
Simulators--Third Edition
----------------------------------------------------------------------------------------------------------------
12-66 ..................... AIUM MUS, Medical Ultrasound Safety Relevant guidance
----------------------------------------------------------------------------------------------------------------
12-96 12-187 NEMA MS 3-2008 Determination of Image Withdrawn and replaced
Uniformity in Diagnostic Magnetic with newer version
Resonance Images
----------------------------------------------------------------------------------------------------------------
12-97 12-188 NEMA MS 1-2008 Determination of Signal-to- Withdrawn and replaced
Noise Ratio (SNR) in Diagnostic Magnetic with newer version
Resonance Imaging
----------------------------------------------------------------------------------------------------------------
12-100 ..................... NEMA UD 3-2004, Standard for Real Time Relevant guidance
Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic
Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------
12-105 ..................... NEMA UD 2-2004, Acoustic Output Title, Relevant
Measurement Standard for Diagnostic guidance
Ultrasound Equipment Version 3
----------------------------------------------------------------------------------------------------------------
12-139 ..................... AIUM AOMS-2005, Acoustic Output Relevant guidance
Measurement Standard for Diagnostic
Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------
12-140 ..................... AIUM RTD1-2005, Standard for Real-Time Relevant guidance
Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic
Ultrasound Equipment Revision 1
----------------------------------------------------------------------------------------------------------------
12-161 12-189 IEC 60601-2-33 (2008) Medical Electrical Withdrawn and replaced
Equipment--Part 2-33: Particular with a newer version
Requirements for the Safety of Magnetic
Resonance Equipment for Medical Diagnosis
Consolidated Edition 2.2
----------------------------------------------------------------------------------------------------------------
12-182 ..................... IEC 60601-2-37:2007, Medical Electrical Relevant guidance
Equipment--Part 2-37: Particular
Requirements for the Basic Safety and
Essential Performance of Ultrasonic
Medical Diagnostic and Monitoring
Equipment
----------------------------------------------------------------------------------------------------------------
12-184 12-190 IEC 61217 (2008) Radiotherapy Equipment-- Withdrawn and replaced
Coordinates, Movements, and Scales with newer version
Consolidated Edition 1.2
----------------------------------------------------------------------------------------------------------------
I. Sterility
----------------------------------------------------------------------------------------------------------------
14-120 14-257 ASTM D3078--02(2008) Standard Test Method Withdrawn and replaced
for Determination of Leaks in Flexible with newer version
Packaging by Bubble Emission
----------------------------------------------------------------------------------------------------------------
14-148 14-258 ASTM F2250--03(2008) Standard Practice for Withdrawn and replaced
Evaluation of Chemical Resistance of with newer version
Printed Inks and Coatings on Flexible
Packaging Materials
----------------------------------------------------------------------------------------------------------------
14-149 14-259 ASTM F2251--03(2008) Standard Test Method Withdrawn and replaced
for Thickness Measurement of Flexible with newer version
Packaging Material
----------------------------------------------------------------------------------------------------------------
14-150 14-260 ASTM F2252--03(2008) Standard Practice for Withdrawn and replaced
Evaluating Ink or Coating Adhesion to with newer version
Flexible Packaging Materials Using Tape
----------------------------------------------------------------------------------------------------------------
J. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-11 15-13 ASTM F2212-02(2008)e1, Standard Guide for Withdrawn and replaced
Characterization of Type I Collagen as a with newer version
Starting Material for Surgical Implants
and Substrates for Tissue Engineered
Medical Products
----------------------------------------------------------------------------------------------------------------
[[Page 11591]]
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: 021.
Table 3
----------------------------------------------------------------------------------------------------------------
Recognition No. Title of Standard Reference No. & Date
----------------------------------------------------------------------------------------------------------------
A. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-160 Maximum Permissible Ambient Noise Levels for Audiometric ANSI ASA S3.1-1999 (R
Test Rooms 2003)
----------------------------------------------------------------------------------------------------------------
4-161 Method for Measuring the Intelligibility of Speech Over ANSI ASA S3.2-1989 (R
Communication Systems 1999)
----------------------------------------------------------------------------------------------------------------
4-162 Procedure for the Computation of Loudness of Steady Sounds ANSI ASA S3.4-2007
----------------------------------------------------------------------------------------------------------------
4-163 Methods for Calculation of the Speech Intelligibility Index ANSI ASA S3.5-1997 (R
2007)
----------------------------------------------------------------------------------------------------------------
4-164 Method for Coupler Calibration of Earphones ANSI ASA S3.7-1995 (R
2003)
----------------------------------------------------------------------------------------------------------------
4-165 Mechanical Coupler for Measurement of Bone Vibrators ANSI ASA S3.13-1987 (R
2007)
----------------------------------------------------------------------------------------------------------------
4-166 Bioacoustical Terminology ANSI ASA S3.20-1995 (R
2003)
----------------------------------------------------------------------------------------------------------------
4-167 Methods for Manual Pure-Tone Threshold Audiometry ANSI ASA S3.21-2004
----------------------------------------------------------------------------------------------------------------
4-168 Occluded Ear Simulator ANSI ASA S3.25-1989 (R
2003)
----------------------------------------------------------------------------------------------------------------
4-169 Method of Measurement of Performance Characteristics of ANSI ASA S3.35-2004
Hearing Aids under Simulated Real-Ear Working Conditions
----------------------------------------------------------------------------------------------------------------
4-170 Specification for a Manikin for Simulated in situ Airborne ANSI ASA S3.36-1985 (R
Acoustic Measurements 2006)
----------------------------------------------------------------------------------------------------------------
4-171 Preferred Earhook Nozzle Thread for Postauricular Hearing ANSI ASA S3.37-1987 (R
Aids 2007)
----------------------------------------------------------------------------------------------------------------
4-172 Testing Hearing Aids with a Broad-Band Noise Signal ANSI ASA S3.42-1992 (R
2007)
----------------------------------------------------------------------------------------------------------------
4-173 Determination of Occupational Noise Exposure and Estimation ANSI ASA S3.44-1996 (R
of Noise-Induced Hearing Impairment 2006)
----------------------------------------------------------------------------------------------------------------
4-174 Procedures for Testing Basic Vestibular Function ANSI ASA S3.45-1999
----------------------------------------------------------------------------------------------------------------
4-175 Methods of Measurement of Real-Ear Performance ANSI ASA S3.46-1997 (R
Characteristics of Hearing Aids 2002)
----------------------------------------------------------------------------------------------------------------
4-176 Criteria for Evaluating Room Noise ANSI ASA S12.2-1995 (R
1999)
----------------------------------------------------------------------------------------------------------------
4-177 Rating Noise with Respect to Speech Interference ANSI ASA S12.65-2006
----------------------------------------------------------------------------------------------------------------
B. General
----------------------------------------------------------------------------------------------------------------
5-45 Standard Practice for Performance Testing of Packages for ASTM D7386-08
Single Delivery Systems
----------------------------------------------------------------------------------------------------------------
C. IVD
----------------------------------------------------------------------------------------------------------------
7-172 Defining, Establishing, and Verifying Reference Intervals in C28-P3
the Clinical Laboratory
----------------------------------------------------------------------------------------------------------------
7-173 Harmonization of Glycohemoglobin Measurements C44-A
----------------------------------------------------------------------------------------------------------------
7-174 Estimation of Total Analytical Error for Clinical Laboratory EP21-A
----------------------------------------------------------------------------------------------------------------
7-175 Apolipoprotein Immunoassays: Development and Recommended ILA15-A
Performance Characteristics
----------------------------------------------------------------------------------------------------------------
7-176 Immunoassay Interference by Endogenous Antibodies ILA30-A
----------------------------------------------------------------------------------------------------------------
[[Page 11592]]
7-177 Performance Standards for Antimicrobial Susceptibility M100-S18
Testing
----------------------------------------------------------------------------------------------------------------
7-178 Quality Control for Commercially Prepared Microbiological M22-A3
Culture Media
----------------------------------------------------------------------------------------------------------------
7-179 Reference Method for Broth Dilution Antifungal M27-S3
Susceptibility Testing of Yeasts
----------------------------------------------------------------------------------------------------------------
7-180 Western Blot Assay for Antibodies to Borrelia burgdorferi M34-A
----------------------------------------------------------------------------------------------------------------
7-181 Abbreviated Identification of Bacteria and Yeasts M35-A
----------------------------------------------------------------------------------------------------------------
7-182 Clinical Use and Interpretation of Serologic Tests for M36-A
Toxoplasma gondii
----------------------------------------------------------------------------------------------------------------
7-183 Reference Method for Broth Dilution Antifungal M38-A2
Susceptibility Testing of Filamentous Fungi
----------------------------------------------------------------------------------------------------------------
7-184 Quality Control of Microbiological Transport Systems M40-A
----------------------------------------------------------------------------------------------------------------
7-185 Viral Culture M41-A
----------------------------------------------------------------------------------------------------------------
7-186 Methods for Antifungal Disk Diffusion Susceptibility Testing M44-A
----------------------------------------------------------------------------------------------------------------
7-187 Zone Diameter Interpretive Standards, Corresponding Minimal M44-S2
Inhibitory Concentration (MIC) Interpretive Breakpoints,
and Quality Control Limits for Antifungal Disk Diffusion
Susceptibility Testing of Yeast
----------------------------------------------------------------------------------------------------------------
7-188 Methods for Antimicrobial Dilution and Disk Susceptibility M45-A
Testing of Infrequently Isolated or Fastidious Bacteria
----------------------------------------------------------------------------------------------------------------
7-189 Principles and Procedures for Blood Cultures M47-A
----------------------------------------------------------------------------------------------------------------
7-190 Quality Control for Commercial Microbial Identification M50-A
Systems
----------------------------------------------------------------------------------------------------------------
7-191 Collection, Transport, Preparation, and Storage of Specimens MM13-A
----------------------------------------------------------------------------------------------------------------
7-192 Interpretive Criteria for Identification of Bacteria and MM18-A
Fungi by DNA Target Sequencing
----------------------------------------------------------------------------------------------------------------
7-193 Evaluation of the Linearity of Quantitative Measurement EP06-A
----------------------------------------------------------------------------------------------------------------
7-194 Protocols for Determination of Limits of Detection and EP17-A
Limits of Quantitation
----------------------------------------------------------------------------------------------------------------
D. Neurology
----------------------------------------------------------------------------------------------------------------
17-7 Neurosurgical implants--Sterile, Single-use Hydrocephalus ISO 7197:2006/Technical
Shunts and Components Corrigendum1:2007
----------------------------------------------------------------------------------------------------------------
E. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-57 Natural Latex Rubber Condoms--Requirements and Test Methods, ISO 4074:2002/
Technical Corrigendum 2 Cor.2:2008(E)
----------------------------------------------------------------------------------------------------------------
F. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-58 Laser Systems for Corneal Reshaping ANSI Z80.11-2007
----------------------------------------------------------------------------------------------------------------
G. Radiology
----------------------------------------------------------------------------------------------------------------
12-191 Ultrasonics--Field Characterization--Test Methods for the IEC 62359:2005
Determination of Thermal and Mechanical Indices Related to
Medical Diagnostic Ultrasonic Fields
----------------------------------------------------------------------------------------------------------------
H. Software/Informatic
----------------------------------------------------------------------------------------------------------------
13-25 Managing and Validating Laboratory Information Systems; CLSI AUTO8-A
Approved Guideline
----------------------------------------------------------------------------------------------------------------
13-26 Autoverification of Clinical Laboratory Test Results; CLSI AUTO10-A
Approved Guideline
----------------------------------------------------------------------------------------------------------------
13-27 IT Security of In Vitro Diagnostic Instruments and Software CLSI AUTO11-A
Systems; Approved Standard
----------------------------------------------------------------------------------------------------------------
13-28 Remote Access to Clinical Laboratory Diagnostic Devices via CLSI AUTO9-A
the Internet; Approved Standard
----------------------------------------------------------------------------------------------------------------
I. Sterility
----------------------------------------------------------------------------------------------------------------
14-261 Sterilization of Health Care Products--Moist Heat--Part 1: ANSI/AAMI/ISO 17665-1:2006
Requirements for the Development, Validation, and Routine
Control of a Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------
[[Page 11593]]
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.
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: 021'' 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: 021. These modifications
to the list or recognized standards are effective upon publication of
this document in the Federal Register.
Dated: March 10, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-5858 Filed 3-17-09; 8:45 am]
BILLING CODE 4160-01-S