[Federal Register: June 18, 2004 (Volume 69, Number 117)]
[Notices]
[Page 34176-34182]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn04-126]
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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: 010
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 of the List of Recognized Standards, Recognition List
Number: 010'' (Recognition List Number: 010), 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 ``Modification to the List of Recognized Standards,
Recognition List Number: 010'' to the Division of Small Manufacturers
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
[[Page 34177]]
requests, or fax your request to 301-443-8818. Submit written comments
concerning this document or to recommend additional standards for
recognition to the contact person (see FOR FURTHER INFORMATION
CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.gov.
This document may also be accessed on FDA's Internet site at http:/www.fda.gov/cdrh/fedregin.html.
See section VI of this document for
electronic access to the searchable database for the current list of
``FDA Recognized Consensus Standards,'' including Recognition List
Number: 010 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, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4766, ext. 156.
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 document
entitled ``Recognition and Use of Consensus Standards.'' This notice
described how FDA will implement its standard recognition program and
provided the initial list of recognized standards.
In Federal Register notices published on October 16, 1998 (63 FR
55617), July 12, 1999 (64 FR 37546), November 15, 2000 (65 FR 69022),
May 7, 2001 (66 FR 23032), January 14, 2002 (67 FR 1774), October 2,
2002 (67 FR 61893), April 28, 2003 (68 FR 22391), and March 8, 2004 (69
FR 10712), FDA modified its initial list of recognized 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. 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: 010
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: 010'' to identify these current
modifications.
In the following table, FDA describes modifications that involve:
(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.
A. Anesthesia
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Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
19 ISO 8382:1988, Processes 19
Resuscitators Intended impacted, extent
for Use with Humans of recognition,
relevant guidance
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42 ISO 5360:1993, Devices affected, 42
Anaesthetic vaporizers-- processes
Agent-specific filling impacted, extent
systems of recognition
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B. General
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Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
2 IEC 60601-1, Medical Contact person 2
Electrical Equipment--
Part 1: General
Requirements for Safety
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28 IEC 60601-1-2 (Second Contact person 28
Edition, 2001) Medical
Electrical Equipment--
Part 1: General
Requirements for
Safety; Electromagnetic
Compatibility--Requirem
ents and Tests
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30 ANSI/AAMI/IEC 60601-1- Correct title of 30
2:2001, Medical standard
Electrical Equipment--
Parts 1 to 2: General
Requirements for
Safety--Collateral
Standard:
Electromagnetic
Compatibility--Requirem
ents and Tests
------------------------------------------------------------------------
C. General Hospital/General Plastic Surgery
[[Page 34178]]
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Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
3 ASTM F754-88, Standard Withdrawn and 108
Specification for replaced with new
Implantable version
Polytetrafluoroethylene
(PTFE) Polymer
Fabricated in Sheet,
Tube and Rod Shapes
------------------------------------------------------------------------
4 ASTM F881-94, Standard Withdrawn and 109
Specification for replaced with
Elastomer Facial newer version
Implants
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6 ASTM F1441-92, Standard Withdrawn and 110
Specification for Soft replaced with
Tissue Expanders newer version
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10 IEC 60601-2-38, Medical Withdrawn and 111
Electrical Equipment-- replaced with
Part 2: Particular newer version
Requirements for the
Safety of Electrically
Operated Hospital Beds
------------------------------------------------------------------------
D. In Vitro Diagnostic
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
47 NCCLS MM2-A2 Withdrawn and 98
Immunoglobulin and T- replaced with
Cell Receptor Gene newer version
Rearrangement Assays;
Approved Guideline--
Second Edition
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84 CEN 13640, Stability Correction to date 84
Testing of In Vitro of standard
Diagnostic Reagents
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E. Materials
------------------------------------------------------------------------
Old Item Replacement
No. Title of Standard Change Item No.
------------------------------------------------------------------------
26 ASTM F1314-01, Standard Title change 26
Specification for
Wrought Nitrogen
Strengthened 22
Chromium - 13 Nickel -
5 Manganese - 2.5
Molybdenum Stainless
Steel Alloy Bar and
Wire for Surgical
Implants (UNS S20910)
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39 ASTM F2052-02, Standard Recognizing a 70
Test Method for newer version
Measurement of with a revised
Magnetically Induced title
Displacement Force on
medical Devices in the
Magnetic Resonance
Environment
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55 ASTM F2182-02a, Standard Recognizing a 71
Test Method for newer version
Measurement of Radio
Frequency Induced
Heating Near Passive
Implants During
Magnetic Resonance
Imaging
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62 ISO 5832-1:1997, Transferred from 56
Implants for Surgery-- Orthopedics 62 to
Metallic materials-- Materials 56
Part 1: Wrought
stainless steel
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64 ISO 5832-3:1996, Transferred from 58
Implants for Surgery-- Orthopedics 64 to
Metallic materials-- Materials 58
Part 3: Wrought
titanium 6-aluminum 4-
vanadium alloy
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65 ISO 5832-4:1996, Transferred from 59
Implants for Surgery-- Orthopedics 65 to
Metallic materials-- Materials 59
Part 4: Cobalt-chromium-
molybdenum casting
alloy
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62 ISO 5832-1:1997, Transferred from 56
Implants for Surgery-- Orthopedics 62 to
Metallic materials-- Materials 56
Part 1: Wrought
stainless steel
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64 ISO 5832-3:1996, Transferred from 58
Implants for Surgery-- Orthopedics 64 to
Metallic materials-- Materials 58
Part 3: Wrought
titanium 6-aluminum 4-
vanadium alloy
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65 ISO 5832-4:1996, Transferred from 59
Implants for Surgery-- Orthopedics 65 to
Metallic materials-- Materials 59
Part 4: Cobalt-chromium-
molybdenum casting
alloy
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66 ISO 5832-5:1993, Transferred from 60
Implants for Surgery-- Orthopedics 66 to
Metallic materials-- Materials 60
Part 5: Wrought cobalt-
chromium-tungsten-
nickel alloy
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67 ISO 5832-6:1997, Transferred from 61
Implants for Surgery-- Orthopedics 67 to
Metallic materials-- Materials 61
Part 6: Wrought cobalt-
nickel-chromium-
molybdenum alloy
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70 ISO 5832-11:1994, Transferred from 63
Implants for Surgery-- Orthopedics 70 to
Metallic materials-- Materials 63
Part 11: Wrought
titanium 6-aluminum 7-
niobium alloy
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[[Page 34179]]
71 ISO 5832-12:1996, Transferred from 64
Implants for Surgery-- Orthopedics 71 to
Metallic materials-- Materials 64
Part 12: Wrought cobalt-
chromium-molybdenum
alloy
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76 ISO 6474-94, Implants Transferred from 66
for surgery--Ceramic Orthopedics 76 to
materials based on high Materials 66
purity alumina
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84 ISO 13782:1996, Implants Transferred from 68
for surgery--Metallic Orthopedics 84 to
materials--Unalloyed Materials 68
tantalum for surgical
implant applications
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117 ISO 5832-2:1999, Transferred from 57
Implants for Surgery-- Orthopedics 117
Metallic Materials-- to Materials 57
Part 2: Unalloyed
Titanium
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118 ISO 5832-9:1992, Transferred from 62
Implants for Surgery-- Orthopedics 118
Metallic Materials-- to Materials 62
Part 9: Wrought High
Nitrogen Stainless
Steel
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119 ISO 5834-2:1998, Transferred from 65
Implants for Surgery-- Orthopedics 119
Ultra-High-Molecular to Materials 65
Weight Polyethylene--
Part 2: Moulded Forms
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143 ISO 7153-1:1991/Amd. Transferred from 67
1:1999, Surgical Orthopedics 143
instruments--Metallic to Materials 67
materials--Part 1:
Stainless steel
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F. Radiology
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Old Item Replacement
No. Standard Change Item No.
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5 ANSI Ph 2.50-1983, Title correction 5
Photography--Direct-
Exposing Medical and
Dental Radiographic
Film/Process Systems--
Determination of ISO
Speed and Average
Gradient
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7 ISO/IEC 10918-1:1994, Title correction 7
Information Technology--
Digital Compression and
Coding of Continuous--
Tone Still Images:
Requirements and
Guidelines
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8 IEC 60336 (R1993), X-ray Title correction 8
Tube Assemblies for
Medical Diagnosis
Characteristics of
Focal Spots
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17 NEMA MS 8-1993 (2000), Reaffirmation 17
Characterization of the
Specific Absorption
Rate for Magnetic
Resonance Imaging
Systems
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22 NEMA XR 5-1992 (R1999), Reaffirmation 22
Measurement of
Dimensions and
Properties of Focal
Spots of Diagnostic X-
ray Tubes
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23 NEMA XR 10-1986 (R1992, Reaffirmation 23
R1998), Measurement of
the Maximum Symmetrical
Radiation Field from a
Rotating Node X-ray
Tube used for Medical
Diagnosis
------------------------------------------------------------------------
24 NEMA XR 11-1993 (R1999), Title correction 24
Test Standard for
Determination of the
Limiting Spatial
Resolution of X-ray
Image Intensifier
Systems
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25 NEMA XR 15-1991 (R1996, Reaffirmation 25
R2001), Test Standard
for the Determination
of the Visible Entrance
Field Size of an X-ray
Image Intensifier
System
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26 NEMA XR 16-1991 (R1996, Reaffirmation 26
R2001), Test Standard
for the Determination
of the System Contrast
Ratio and the System
Veiling Glare Index of
an X-ray Image
Intensifier System
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27 NEMA XR 17-1993 (R1999), Reaffirmation 27
Test Standard for the
Measurement of the
Image Signal Uniformity
of an X-ray Image
Intensifier System
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28 NEMA XR 18-1993 (R1999), Reaffirmation 28
Test Standard for the
Determination of the
Radial Image Distortion
of an X-ray Image
Intensifier System
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29 NEMA XR 19-1993 (R1999), Reaffirmation 29
Thermal and Loading
Characteristics of X-
ray Tubes used for
Medical Diagnosis
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[[Page 34180]]
44 AIUM AOMS--Acoustic Title correction 44
Output Measurement and reaffirmation
Standard for Diagnostic
Ultrasound Equipment
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46 AIUM RTD1--Standard for Title correction 46
Real-Time Display of and reaffirmation
Thermal and Mechanical
Acoustic Output Indices
on Diagnostic
Ultrasound Equipment
Revision 1
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48 AIUM AOL--Acoustic Title correction 48
Output Labeling
Standard for Diagnostic
Ultrasound Equipment: A
Standard for How
Manufacturers Should
Specify Acoustic Output
Data
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61 UL 122-1999, Standard Title correction 61
for Safety of
Photographic Equipment--
4th Edition
------------------------------------------------------------------------
66 AIUM MUS--Medical Title correction 66
Ultrasound Safety and reaffirmation
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72 NEMA UD 3-1998, Revision Title correction 72
1, Standard for Real
Time Display of Thermal
and Mechanical Acoustic
Output Indices on
Diagnostic Ultrasound
Equipment
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11 NEMA MS 2-2003, Withdrawn and 95
Determination of Two- replaced with
Dimensional Geometric newer version
Distortion in
Diagnostic Magnetic
Resonance Images
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12 NEMA MS 3-2003, Withdrawn and 96
Determination of Image replaced with
Uniformity in newer version
Diagnostic Magnetic
Resonance Images
------------------------------------------------------------------------
77 NEMA MS-1-2001, Withdrawn and 97
Determination of Signal replaced with
to Noise Ratio (SNR) in newer version
Diagnostic Magnetic
Resonance Images
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69 NEMA MS 6-1991 (R2000), Reaffirmation 69
Characterization of
Special Purpose Coils
for Diagnostic Magnetic
Resonance Images
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3 ANSI IT1.49-1995, Withdrawn and ..............
Photography (Films)-- replaced with
Medical Radiographic Item 98
Cassettes/Screens/Films-
Dimensions
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14 NEMA MS 5-2003, Withdrawn and 99
Determination of Slice replaced with
Thickness in Diagnostic newer version
Magnetic Resonance
Imaging
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G. Sterility
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
76 AAMI/ANSI/ISO 10993- Deleted 76
7:1995 (R) 2001, ``Hemodialyzers''
Biological Evaluation from Extent of
of Medical Devices-- Recognition
Part 7: Ethylene Oxide
Sterilization Residuals
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III. Listing of New Entries
The listing of new entries and consensus standards added as
``Modifications to the List of Recognized Standards,'' under
Recognition List Number: 010, is as follows:
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
----------------------------------------------------------------------------------------------------------------
47 Ancillary devices for expired air resuscitation AS 4259-1995
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48 Standard Specification for Electrically Powered Home Care ASTM F1246-91(1999)
Ventilators, Part 1--Positive-Pressure Ventilators and
Ventilator Circuits
----------------------------------------------------------------------------------------------------------------
49 Standard Specification for Suction Catheters for Use in the ASTM F1981-99
Respiratory Tract
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B. General
[[Page 34181]]
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Item No. Title of Standard Reference No. and Date
----------------------------------------------------------------------------------------------------------------
33 Medical Electrical Equipment--Parts 1 to 8: General requirements IEC 60601-1-8:2003
for safety--Collateral Standard: Alarm systems--Requirements,
tests, and guidelines--General requirements and guidelines for
alarm systems in medical equipment
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C. In Vitro Diagnostic
----------------------------------------------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
----------------------------------------------------------------------------------------------------------------
99 Nucleic Acid Amplification Assays for Molecular Hematopathology; NCCLS MM5-A:2000
Approved Guideline
----------------------------------------------------------------------------------------------------------------
100 In Vitro Diagnostic Test Systems--Requirements for In Vitro Whole ISO 15197:2003
Blood Glucose Monitoring Systems Intended for Use by Patients
for Self Testing in Management of Diabetes Mellitus, First
Edition
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101 Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor NCCLS H51-A:2002
Activity; Approved Guideline
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D. Materials
----------------------------------------------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
----------------------------------------------------------------------------------------------------------------
72 Standard Test Method for Measurement of Magnetically Induced ASTM F2213-04
Torque on Medical Devices in the Magnetic Resonance Environment
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E. Radiology
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Item No. Title of Standard Reference No. and Date
----------------------------------------------------------------------------------------------------------------
98 Medical Electrical Equipment--Dosimeters with Ionization Chambers IEC 60731--Amendment 1
as Used in Radiotherapy 2002-06
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IV. List of Recognized Standards
FDA maintains the agency's current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed directly at
FDA's Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
FDA will incorporate the modifications
and minor revisions described in this notice into the database, and
upon publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under 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 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 obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal computer with access to
the Internet. Updated on a regular basis, the CDRH home page includes
the guidance as well as the current list of recognized standards and
other standards related documents. After publication in the Federal
Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 010'' will be available
on the CDRH home page. You may access the CDRH home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 hyperlink at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/stdsprog.html.
This Federal Register notice of modifications in FDA's
recognition of consensus standards will be available, upon publication,
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
[[Page 34182]]
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: 010.'' These
modifications to the list or recognized standards are effective upon
publication of this notice in the Federal Register.
Dated: June 2, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-13725 Filed 6-17-04; 8:45 am]
BILLING CODE 4160-01-S