[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Notices]
[Pages 30756-30761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10626]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0226]
Food and Drug Administration Modernization Act of 1997;
Modifications to the List of Recognized Standards, Recognition List
Number: 012
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 012'' (Recognition List Number: 012), 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 on a 3.5''
diskette of ``Modifications to the List of Recognized Standards,
Recognition List Number: 012'' to the Division of Small Manufacturers,
International and Consumer Assistance, Center for Devices and
Radiological Health (HFZ-220), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your requests, or fax your
request to 301-443-8818. Submit written comments concerning this
document, or recommendations for additional standards for recognition,
to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit
electronic comments by e-mail: [email protected]. This document
may also be accessed on FDA's Internet site at http://www.fda.gov/cdrh/fedregin.html. See section VI of this document for electronic access to
the searchable database for the current list of FDA recognized
consensus standards, including Recognition List Number: 012
modifications and other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 12720
Twinbrook Pkwy., MD 20857, 301-827-0021.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards, developed by
international and national organizations, for use in satisfying
portions of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA will implement its standard recognition program and provided
the initial list of FDA recognized consensus standards.
In Federal Register notices published on October 16, 1998 (63 FR
55617), July 12, 1999 (64 FR 37546), November 15, 2000 (65 FR 69022),
May 7, 2001 (66 FR 23032), January 14, 2002 (67 FR 1774), October 2,
2002 (67 FR 61893), April 28, 2003 (68 FR 22391), March 8, 2004 (69 FR
10712), June 18, 2004 (69 FR 34176), and October 4, 2004 (69 FR 59240),
FDA modified its initial list of FDA recognized consensus standards.
These notices described 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 at
http://www.fda.gov/cdrh/stdsprog.html. 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 Recognition List Number: 012
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: 012'' to identify these current
modifications.
In table 1 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others, (2) the correction of errors made by FDA in listing previously
recognized standards, and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III of this document, FDA lists modifications the agency
is making that involve the initial addition of standards not previously
recognized by FDA.
Table 1.
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Old Item Replacement
No. Standard Change Item No.
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A. Anesthesia
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3 ASTM F1161-88, Standard Contact ..............
Specification for Minimum person
Performance and Safety
Requirements for Components and
Systems of Anesthesia Gas
Machines
------------------------------------------------------------------------
4 ASTM F1242-96, Standard Withdrawn ..............
Specification for Cuffed and
Uncuffed Tracheal Tubes
------------------------------------------------------------------------
7 ASTM F1627-95, Standard Withdrawn ..............
Specification for Pediatric
Tracheostomy Tubes
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[[Page 30757]]
9 IEC 60601-2-12 (2001-10), Medical Withdrawn 60
Electrical Equipment--Part 2-12: and
Particular Requirements for the replaced
Safety of Lung Ventilators-- with newer
Critical Care Ventilators version
------------------------------------------------------------------------
15 ISO 5361-4: 1987, Tracheal Tubes-- Contact ..............
Part 4: Cole Type person
------------------------------------------------------------------------
18 ISO 8359: 1996, Oxygen Contact ..............
Concentrators for Medical Use-- person
Safety Requirements
------------------------------------------------------------------------
19 ISO 8382: 1988, Resuscitators Contact ..............
Intended for Use With Humans person
------------------------------------------------------------------------
20 ISO 9703-1: 1992, Anesthesia and Withdrawn ..............
Respiratory Care Alarm Signals--
Part 1: Visual Alarm Signals
------------------------------------------------------------------------
21 ISO 9703-2: 1994, Anesthesia and Withdrawn ..............
Respiratory Care Alarm Signals--
Part 2: Auditory Alarm Signals
------------------------------------------------------------------------
30 IEC 60601-2-13 (2003-05), Medical Withdrawn 61
Electrical Equipment--Part 2-13: and
Particular Requirements for the replaced
Safety and Essential Performance with newer
of Anesthetic Systems version
------------------------------------------------------------------------
31 ISO 5356-1: 2004, Anaesthetic and Withdrawn 62
Respiratory Equipment--Conical and
Connectors--Part 1: Cones and replaced
Sockets with newer
version
------------------------------------------------------------------------
35 ISO 5361: 1999, Anaesthetic and Contact ..............
Respiratory Equipment--Tracheal person
Tubes and Connectors
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38 CGA V-1: 2003, Standard for Withdrawn 63
Compressed Gas Cylinder Valve and
Outlet and Inlet Connections replaced
with newer
version
------------------------------------------------------------------------
42 ISO 5360: 1993, Anaesthetic Contact ..............
Vaporizers--Agent Specific person
Filling Systems
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44 ISO 5366-1: 2000, Anaesthetic and Contact ..............
Respiratory Equipment-- person and
Tracheostomy Tubes--Part 1: type of
Tubes and Connectors for Use in standard
Adults
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50 ASTM F920-93 (1999), Standard Contact ..............
Specification for Minimum person
Performance and Safety
Requirements for Resuscitators
Intended for Use With Humans
------------------------------------------------------------------------
52 ASTM F1463-93 (1999), Standard Contact ..............
Specification for Alarm Signals person
in Medical Equipment Used in
Anesthesia and Respiratory Care
------------------------------------------------------------------------
53 ASTM F1464-93 (1999), Standard Contact ..............
Specification for Oxygen person
Concentrators for Domiciliary
Use
------------------------------------------------------------------------
54 ASME PVHO-1-2002-2003, Safety Withdrawn 64
Standard for Pressure Vessels and
for Human Occupancy replaced
with newer
version
------------------------------------------------------------------------
55 ASTM F1054-01, Standard Contact ..............
Specification for Conical person
Fittings
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57 ASTM F1101-90 (2003)e1, Standard Contact ..............
Specification for Ventilators person
Intended for Use During
Anesthesia
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59 ASTM F1456-01, Standard Contact ..............
Specification for Minimum person
Performance and Safety
Requirements for Capnometers
������������������������������������������������������������������������
B. Cardiovascular/Neurology
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3 AAMI NS28: 1988/(R)1993, Contact ..............
Intracranial Pressure Monitoring person
------------------------------------------------------------------------
18 IEC 60601-2-27 (1994), Medical Contact ..............
Electrical Equipment--Part 2: person and
Particular Requirements for the processes
Safety of Electrocardiographic affected
Monitoring Equipment
------------------------------------------------------------------------
43 ANSI/AAMI EC38: 1998, Ambulatory Contact ..............
Electrocardiographs person,
processes
affected
and extent
of
recognitio
n
������������������������������������������������������������������������
C. Dental/Ear, Nose, and Throat
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61 ISO 1562: 1993, Dental Casting Contact ..............
Gold Alloys person
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116 ISO 10139-1: 1991, Dentistry-- Date of ..............
Resilient Lining Materials for standard
Removable Dentures--Part 1:
Short-Term Materials
������������������������������������������������������������������������
D. General Hospital/General Plastic Surgery
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[[Page 30758]]
1 AAMI BF7: (R2002), Blood Withdrawn 119
Transfusion Micro-Filters and
replaced
with newer
version
------------------------------------------------------------------------
29 IEC 60601-2-19 1996-10, Title ..............
``Amendment 1''--Medical
Electrical Equipment--Part 2:
Particular Requirements for
Safety of Baby Incubators
------------------------------------------------------------------------
32 IEC 60601-2-20 1996-10, Title ..............
``Amendment 1''--Medical
Electrical Equipment--Part 2:
Particular Requirements for the
Safety of Transport Incubators
------------------------------------------------------------------------
37 ASTM F1054-01, Standard Withdrawn 120
Specification for Conical and
Fittings replaced
with newer
version
------------------------------------------------------------------------
63 ISO 8536-7-1999, Infusion Title ..............
Equipment for Medical Use--Part
7: Caps Made of Aluminum-
Plastics Combinations for
Infusion Bottles
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65 ISO 8536-2-2001, Infusion Withdrawn 121
Equipment for Medical Use--Part and
2: Closures for Infusion Bottles replaced
with newer
version
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67 ISO 8536-5-2004, Infusion Withdrawn 122
Equipment for Medical Use--Part and
5: Burette Type Infusion Sets replaced
for Single Use, Gravity Feed with newer
version
------------------------------------------------------------------------
71 ASTM E667-03, Standard Withdrawn 123
Specification for Mercury-in- and
Glass, Maximum Self-Registering replaced
Clinical Thermometers with newer
version
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73 ASTM E1104-03, Standard Withdrawn 124
Specification for Clinical and
Thermometer Probe Covers and replaced
Sheaths with newer
version
------------------------------------------------------------------------
74 ASTM E1965-03, Standard Withdrawn 125
Specification for Infrared and
Thermometers for Intermittent replaced
Determination of Patient with newer
Temperature version
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75 ISO 8536-4-2004, Infusion Withdrawn 126
Equipment for Medical Use--Part and
4: Infusion Sets for Single Use, replaced
Gravity Feed with newer
version
------------------------------------------------------------------------
76 ISO 1135-4-2004, Transfusion Withdrawn 127
Equipment for Medical Use--Part and
4: Transfusion Sets for Single replaced
Use with newer
version
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78 ASTM F1670-03, Standard Test Withdrawn 128
Method for Resistance of and
Materials Used in Protective replaced
Clothing to Penetration by with newer
Synthetic Blood version
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79 ISO 594/2-1998, Conical Fittings Withdrawn 129
With a 6% (Luer) Taper for and
Syringes, Needles and Certain replaced
Other Medical Equipment--Part 2: with newer
Lock Fittings version
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E. Materials
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36 ASTM F1801-97 (2004), Standard Withdrawn 103
Practice for Corrosion Fatigue and
Testing of Metallic Implant replaced
Materials with newer
version
------------------------------------------------------------------------
51 ASTM F1108-04, Standard Withdrawn 104
Specification for Titanium- and
6Aluminum-4Vanadium Alloy replaced
Castings for Surgical Implants with newer
(UNS R56406) version
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69 Title: ISO 5832-10: 1996, Withdrawn ..............
Implants for Surgery--Metallic
Materials--Part 10: Wrought
Titanium 5-Aluminum 2,5-Iron
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70 Title: ASTM F2052-02, Standard Error in 70
Test Method for Measurement of October 4,
Magnetically Induced 2004
Displacement Force on Medical Federal
Devices in the Magnetic Register
Resonance Environment Notice (69
FR 59240)
(Recogniti
on List
Number:
011)
[Docket
No. 2004N-
0226]--not
withdrawn
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96 ASTM F1635-04(a), Standard Test Withdrawn 105
Method for In Vitro Degradation and
Testing of Hydrolytically replaced
Degradable Polymer Resins and with newer
Fabricated Forms for Surgical version
Implants
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F. Ophthalmic
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5 ISO 9363-1: 1994, Optics and Withdrawn ..............
Optical Instruments--Contact
Lenses--Determination of
Cytotoxicity of Contact Lens
Material--Part 1: Agar Overlay
Test and Growth Inhibition Test
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[[Page 30759]]
14 ANSI Z80.20-2004, Ophthalmics-- Withdrawn 34
Contact Lenses--Standard and
Terminology, Tolerances, replaced
Measurements and Physicochemical with newer
Properties version
------------------------------------------------------------------------
15 ISO 9394:1998, Ophthalmic Optics-- Title ..............
Contact Lenses and Contact Lens
Care Products--Determination of
Biocompatibility by Ocular Study
Using Rabbit Eyes
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30 ANSI Z80.7-2002, Ophthalmics-- Title ..............
Intraocular Lenses
������������������������������������������������������������������������
G. Radiology
------------------------------------------------------------------------
1 ANSI PH 2.43-1982, Method for Title ..............
Sensitometry/Medical X-Ray
Screen-Film
------------------------------------------------------------------------
5 ANSI PH 2.50-1983, Method/ Title ..............
Sensitometry Direct-Exposure
Medical/Dental
------------------------------------------------------------------------
7 IEC/ISO 10918-1: 1994, Title ..............
Information Technology--Digital
Compression and Coding of
Continuous-Tone Still Images--
Part 1: Requirements and
Guidelines
------------------------------------------------------------------------
8 IEC 60336 (R1993), X-Ray Tube Title and ..............
Assemblies for Medical standards
Diagnosis--Characteristics of developmen
Focal Spots t
organizati
on
------------------------------------------------------------------------
14 NEMA MS 5-2003, Determination of Withdrawn 125
Slice Thickness in Diagnostic and
Magnetic Resonance Imaging replaced
with newer
version
------------------------------------------------------------------------
22 IEC NEMA XR5-1992 (R1999), Withdrawn ..............
Measurement of Dimensions and
Properties of Focal Spots of
Diagnostic X-Ray Tubes
------------------------------------------------------------------------
23 NEMA XR 10-1986 (R1992, R1998), Contact ..............
Measurement of the Maximum person,
Symmetrical Radiation Field From title, and
a Rotating Anode X-Ray Tube Used standards
for Medical Diagnosis developmen
t
organizati
on
------------------------------------------------------------------------
33 IEC 60601-2-1: 1998, Medical Withdrawn ..............
Electrical Equipment--Part 2:
Particular Requirements for
Medical Electron Accelerators in
the Range 1 MeV to 50 MeV
------------------------------------------------------------------------
36 IEC 60601-2-9 (1996-10), Medical Title ..............
Electrical Equipment--Part 2:
Particular Requirements for the
Safety of Patient Contact
Dosimeters Used in Radiotherapy
With Electrically Connected
Radiation Detectors--ed. 2.0
------------------------------------------------------------------------
40 IEC 60601-2-28: 2003, Medical Withdrawn 126
Electrical Equipment--Part 2: and
Particular Requirements for the replaced
Safety of X-Ray Source with newer
Assemblies and X-Ray Tube version
Assemblies for Medical
Diagnosis--ed. 1.0
------------------------------------------------------------------------
42 IEC 60601-2-32: 2003, Medical Withdrawn 127
Electrical Equipment--Part 2: and
Particular Requirements for the replaced
Safety of Associated Equipment with newer
of X-Ray Equipment--ed. 1.0 version
------------------------------------------------------------------------
50 IEEE N42.13-1993, Calibration and Withdrawn 128
Usage of ``Dose Calibrator'' and
Ionization Chambers for the replaced
Assay of Radionuclides with newer
version
------------------------------------------------------------------------
52 UL 544 (1998), Standard for Title ..............
Medical and Dental Equipment--
ed. 4.0
------------------------------------------------------------------------
58 ANSI N43.6-1997, Sealed Title and ..............
Radioactive Sources, standards
Classification developmen
t
organizati
on
------------------------------------------------------------------------
61 UL 122 (1999), Standard for Title ..............
Photographic Equipment--ed. 4.0
------------------------------------------------------------------------
62 UL 187 (1998), Standard for X-Ray Title ..............
Equipment--ed. 7.0
------------------------------------------------------------------------
74 NEMA MS 7-1998, Measurement Withdrawn ..............
Procedure for Time-Varying
Gradient Fields (dB/dt) for
Magnetic Resonance Imaging
Systems
------------------------------------------------------------------------
75 NEMA NU 1-2004, Performance Withdrawn 129
Measurements of Scintillation and
Cameras replaced
with newer
version
------------------------------------------------------------------------
83 IEC 60601-2-37 2004, Medical Withdrawn 130
Electrical Equipment--Part 2-37: and
Particular Requirements for the replaced
Safety of Ultrasonic Medical with newer
Diagnostic and Monitoring version
Equipment Consolidated, ed. 1.1
------------------------------------------------------------------------
87 IEC 61217 2003, Radiotherapy Withdrawn 131
Equipment--Coordinates, and
Movements and Scales replaced
Consolidated, ed. 1.1 with newer
version
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[[Page 30760]]
90 IEC 60601-2-1 (1998-06), Medical Title ..............
Electrical Equipment--Part 2-1:
Particular Requirements for the
Safety of Electron Accelerators
in the Range 1 MeV to 50 MeV
------------------------------------------------------------------------
91 IEC 60601-2-8 (1997-08), Title ..............
Amendment 1--Medical Electrical
Equipment--Part 2: Particular
Requirements for the Safety of
Therapeutic X-Ray Equipment
Operating in the Range 10 kV to
1 MV
------------------------------------------------------------------------
98 IEC 60731 (2002-06), Amendment 1-- Withdrawn 132
Medical Electrical Equipment-- and
Dosimeters With Ionization replaced
Chambers as Used in Radiotherapy with newer
version
------------------------------------------------------------------------
120 IEC 60601-2-44 (2002-11), Medical Title ..............
Electrical Equipment--Part 2-44:
Particular Requirements for the
Safety of X-Ray Equipment for
Computed Tomography--ed. 2.1
������������������������������������������������������������������������
H. Sterility
------------------------------------------------------------------------
121 ASTM D4169-04a, Standard Practice Extent of ..............
for Performance Testing of recognitio
Shipping Containers and Systems n
------------------------------------------------------------------------
123 ASTM F2096-04, Standard Test Title ..............
Method for Detecting Gross Leaks
in Medical Packaging by Internal
Pressurization (Bubble Test)
------------------------------------------------------------------------
135 ANSI/AAMI ST63: 2002, Title ..............
Sterilization of Health Care
Products--Requirements for the
Development, Validation and
Routine Control of an Industrial
Sterilization Process for
Medical Devices--Dry Heat
------------------------------------------------------------------------
III. Listing of New Entries
The listing of new entries and consensus standards added as
modifications to the list of recognized standards under Recognition
List Number: 012, follows:
Table 2.
------------------------------------------------------------------------
Reference No.
Item No. Title of Standard and Date
------------------------------------------------------------------------
A. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
114 Pen-Injectors for Medical Use--Part 1: ISO 11608-1:
Pen-Injectors--Requirements and Test 2000
Methods
------------------------------------------------------------------------
115 Pen-Injectors for Medical Use--Part 2: ISO 11608-2:
Needles--Requirements and Test Methods 2000
------------------------------------------------------------------------
116 Pen-Injectors for Medical Use--Part 3: ISO 11608-3:
Finished Cartridges--Requirements and 2000
Test Methods
------------------------------------------------------------------------
117 Standard Specification for Blood/ ASTM F2172-02
Intravenous Fluid/Irrigation Fluid
Warmers
------------------------------------------------------------------------
118 Standard Specification for Circulating ASTM F2196-02
Liquid and Forced Air Patient
Temperature Management Devices
������������������������������������������������������������������������
B. Radiology
------------------------------------------------------------------------
121 Ultrasonics--Surgical Systems-- IEC 61847: 1998
Measurement and Declaration of the Basic
Output Characteristics, ed. 1.0
------------------------------------------------------------------------
122 Medical Electrical Equipment-- IEC 62083: 2000
Requirements for the Safety of
Radiotherapy Treatment Planning Systems,
ed. 1.0
------------------------------------------------------------------------
123 Ultrasonics--Physiotherapy Systems-- IEC 61689: 1996
Performance Requirements and Methods of
Measurement in the Frequency Range 0.5
MHz to 5 MHz, ed. 1.0
������������������������������������������������������������������������
C. Sterility
------------------------------------------------------------------------
144 Standard Test Method for Linear ASTM F2203-02e1
Measurement Using Precision Steel Rule
------------------------------------------------------------------------
145 Standard Practice for Coating/Adhesive ASTM F2217-02
Weight Determination
------------------------------------------------------------------------
146 Standard Test Method of Leaks in Non- ASTM F2227-02
Sealed and Empty Medical Packaging Trays
by CO2 Tracer Gas Method
------------------------------------------------------------------------
147 Standard Test Method for Non-Destructive ASTM F2228-02
Detection of Leaks in Medical Packaging
Which Incorporates Porous Barrier
Material by CO2 Tracer Gas Method
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[[Page 30761]]
148 Standard Practice for Evaluation of ASTM F2250-03
Chemical Resistance of Printed Inks and
Coatings on Flexible Packaging Materials
------------------------------------------------------------------------
149 Standard Test Method for Thickness ASTM F2251-03e1
Measurement of Flexible Packaging
Materials
------------------------------------------------------------------------
150 Standard Practice for Evaluating Ink or ASTM F2252-03
Coating Adhesion to Flexible Packaging
Materials Using Tape
------------------------------------------------------------------------
151 Standard Test Method for Nondestructive ASTM F2338-04
Detection of Leaks in Packages by Vacuum
Decay Method
------------------------------------------------------------------------
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
In order to receive ``Guidance on the Recognition and Use of
Consensus Standards'' via your fax machine, call the Center for Devices
and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the
system. At the second voice prompt, press 1 to order a document. Enter
the document number 321 followed by the pound sign. Follow the
remaining voice prompts to complete your request.
You may also 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: 012'' 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: 012. These modifications
to the list or recognized standards are effective upon publication of
this notice in the Federal Register.
Dated: May 16, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-10626 Filed 5-26-05; 8:45 am]
BILLING CODE 4160-01-S