Reports and guidance documents; availability, etc.: FDA Modernization Act of 1997 Recognized Standards List modifications (Recognition List Number 019),
[Federal Register: December 19, 2007 (Volume 72, Number 243)]
[Notices]
[Page 71924-71930]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de07-83]
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: 019
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: 019'' (Recognition List Number: 019), 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: 019'' to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.gov. This document may also be accessed on FDA's
Internet site at http://www.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: 019 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, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0533.
SUPPLEMENTARY INFORMATION:
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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 of this document.
Table 1
Federal Register Cite
October 16, 1998 (63 FR 55617) July 12, 1999 (64 FR 37546) November 15, 2000 (65 FR 69022) May 7, 2001 (66 FR 23032) January 14, 2002 (67 FR 1774) October 2, 2002 (67 FR 61893) April 28, 2003 (68 FR 22391) March 8, 2004 (69 FR 10712) June 18, 2004 (69 FR 34176) October 4, 2004 (69 FR 59240) May 27, 2005 (70 FR 30756) November 8, 2005 (70 FR 67713) March 31, 2006 (71 FR 16313) June 23, 2006 (71 FR 36121) November 3, 2006 (71 FR 64718) May 21, 2007 (72 FR 28500) September 12, 2007 (72 FR 52142)
These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains ``hypertext markup
[[Page 71925]]
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.
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Modifications to the List of Recognized Standards, Recognition List Number: 019
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: 019 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.
Old Item
Replacement No.
Standard
Change
Item No.
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Anesthesia
11
IEC 60601-3-1:1996-08 Medical Title Change .............. Electrical Equipment - Part Contact person 3-1: Essential Performance Requirement for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring Equipment
18
ISO 8359:1996 Oxygen
Contact person .............. Concentrators for Medical Use - Safety Requirements
51
ASTM F1100-90(1997) Standard Contact person .............. Specification for
Relevant Ventilators Intended for Use guidance in Critical Care
57
ASTM F1101-90(2003)e1
Contact person .............. Standard Specification for Ventilators Intended for Use During Anesthesia
59
ASTM F1456-01 Standard
Relevant
.............. Specification for Minimum guidance Performance and Safety Requirements for Capnometers
60
IEC 60601-2-12:(2001-10) Contact person .............. Medical Electrical Equipment Relevant - Part 2-12: Particular
guidance Requirements for the Safety of Lung Ventilators - Critical Care Ventilators
61
IEC 60601-2-13(2003-05):, Relevant
.............. Medical electrical equipment guidance - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
65
ISO 21647: 2004 Medical
Title Change .............. Electrical Equipment -
Relevant Particular Requirements for guidance the Basic Safety and Essential Performance of Respiratory Gas Monitors
69
ASTM F1464-93(2005) Standard Contact person .............. Specification for Oxygen Concentrators for Domiciliary Use
70
ASTM F 1246-91 (2005)
Contact person .............. Standard Specification for Relevant Electrically Powered Home guidance Care Ventilators, Part 1 - Positive-Pressure Ventilators and Ventilator Circuits
71
ISO 10651-5:2006 Lung
Contact person .............. Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas- powered Emergency Resuscitators
-
General
20
ASTM F1140:1988: Standard Withdrawn .............. Test Method for Failure Resistance of Unrestrained and Nonrigid Packages for Medical Applications
-
General Hospital/General Plastic Surgery
21
ISO 10555-3: 1996 Sterile, Withdrawn
171 Single-use Intravascular duplicate Catheters - Part 3: Central Venous Catheters
81
ASTM E1061-01(2007) Standard Withdrawn and
200 Specification for Direct- replaced with Reading Liquid Crystal
newer version Forehead Thermometers
[[Page 71926]]
111
IEC 60601-2-38: 1996 Medical Withdrawn
182 Electrical Equipment - Part duplicate 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds
117
ASTM F2172-02:, Standard Contact person .............. Specification for Blood/ Intravenous Fluid/Irrigation Fluid Warmers
121
ISO 8536-2-2001 Infusion Withdrawn
173 Equipment for Medical Use - duplicate Part 2: Closures for Infusion Bottles
126
ISO 8536-4:2007 Infusion Withdrawn and
201 Equipment for Medical Use -- replaced with Part 4: Infusion Sets for newer version Single-use, Gravity Feed
162
ISO 8536-1:2000/Amendment Withdrawn
172 1:2004 Infusion Equipment duplicate for Medical Use - Part 1: Infusion Glass Bottles
-
In Vitro Diagnostics
31
CLSI H20-A2 Reference
Withdrawn and
130 Leukocyte (WBC) Differential replaced with Count (Proportional) and newer version Evaluation of Instrumental Methods; Approved Standard-- Second Edition
-
Materials
3
ASTM F90-07 Standard
Withdrawn and
145 Specification for Wrought replaced with Cobalt-20 Chromium-15
newer version Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
30
ASTM F1537-07 Standard
Withdrawn and
152 Specification for Wrought replaced with Cobalt-28Chromium-6Molybdenu newer version m Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
41
ASTM F2066-07 Standard
Withdrawn and
146 Specification for Wrought replaced with Titanium-15 Molybdenum Alloy newer version for Surgical Implant Applications (UNS R58150)
42
ASTM F2119-07 Standard Test Withdrawn and
153 Method for Evaluation of MR replaced with Image Artifacts from Passive newer version Implants
45
ASTM F562-07 Standard
Withdrawn and
147 Specification for Wrought replaced with 35Cobalt-35Nickel-20Chromium newer version -10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
48
ASTM F899-07 Standard
Withdrawn and
148 Specification for Stainless replaced with Steel for Surgical
newer version Instruments
56
ISO 5832-1:2007 Implants for Withdrawn and
149 Surgery -- Metallic
replaced with Materials -- Part 1: Wrought newer version Stainless Steel
62
ISO 5832-9:2007 Implants for Withdrawn and
150 Surgery - Metallic Materials replaced with - Part 9: Wrought High
newer version Nitrogen Stainless Steel
64
ISO 5832-12:2007 Implants for Withdrawn and
151 surgery -- Metallic
replaced with materials -- Part 12:
newer version Wrought cobalt-chromium- molybdenum alloy
-
OB-GYN/Gastroenterology
5
IEC 60601-2-18 (1996) Medical Withdrawn
42 Electrical Equipment - Part duplicate 2: Particular Requirements for the Safety of Endoscopic Equipment
-
Ophthalmic
35
ISO 10939:2007 Ophthalmic Contact person .............. Instruments -- Slit-lamp Microscopes
37
ISO 10942:2006 Ophthalmic Contact person .............. Instruments -- Direct ophthalmoscopes
38
ISO 10943:2006 Ophthalmic Contact person .............. Instruments -- Indirect ophthalmoscopes
39
ISO 12865:2006 Ophthalmic Contact person .............. Instruments -- Retinoscopes
51
ISO 15004-2:2007 Ophthalmic Contact person .............. Instruments--Fundamental Requirements and Test Methods Part 2: Light Hazard Protection
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Radiology
[[Page 71927]]
7
IEC / ISO 10918-1:1994
Withdrawn
150 Information Technology-- duplicate Digital Compression and Coding of Continuous-tone Still Images - Part 1: Requirements and Guidelines
76
NU 2-2007 Performance
Withdrawn and
167 Measurements of Positron replaced with Emission Tomographs
newer version
84
IEC 60825-1 Ed. 2.0 (2007) Withdrawn and
168 Safety of Laser Products - replaced with Part 1: Equipment
newer version Classification and Requirements
85
IEC 60601-2-22 Ed. 3.0 (2007) Withdrawn and
169 Medical Electrical Equipment replaced with - Part 2-22: Particular
newer version Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment
90
IEC 60601-2-1 (1998-06)
Withdrawn
152 Medical Electrical Equipment duplicate - Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV
102
ANSI / IESNA RP-27.2-2000 Contact person .............. Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
103
ANSI / IESNA RP-27.3-1996 Contact person .............. Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
112
ISO 11670:2003 Lasers and Withdrawn
156 Laser-related Equipment - duplicate Test Methods for Laser Beam Parameters - Beam Positional Stability
114
ISO 13694:2000 Optics and Withdrawn
157 Optical Instruments - Lasers duplicate and Laser-related Equipment - Test Methods for Laser Beam Power (energy) Density Distribution
119
NEMA PS 3.1 - 3.18 (2007) Withdrawn and
170 Digital Imaging and
replaced with Communications in Medicine newer version (DICOM) Set
153
ANSI / IESNA RP-27.1-2005 Contact person .............. Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
-
-
Software/Informatics
4
ANSI/UL 1998 Software in Relevant
.............. Programmable Components
guidance
5
IEC 60601-3-1:1996-08 Medical Relevant
.............. electrical equipment - Part guidance 3-1: Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
8
IEC 62304 Ed. 1.0 Medical Relevant
.............. device software - Software guidance life cycle processes
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Sterility
25
ANSI/AAMI/ISO 11135-1:2007 Withdrawn and
228 Sterilization of Health Care replaced with Products - Ethylene oxide - newer version Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
63
ASTM F1886: 1998 (2004)
Relevant
.............. Standard Test Method for guidance Determining Integrity of Seals for Medical Packaging by Visual Inspection
64
ASTM F1929:1998 (2004)
Relevant
.............. Standard Test Method for guidance Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
86
ASTM F1980-07 Standard Guide Withdrawn and
229 for Accelerated Aging of replaced with Sterile Barrier Systems for newer version Medical Devices
120
ASTM D3078:2002 Standard Test Relevant
.............. Method for Determination of guidance Leaks in Flexible Packaging by Bubble Emission
136
AAMI/ANSI ST67:2003
Relevant
.............. Sterilization of Health Care guidance Products - Requirements for Products Labeled 'Sterile' 1st edition
144
ASTM F2203-02(2007) Standard Withdrawn and
230 Test Method for Linear
replaced with Measurement Using Precision newer version Steel Rule
[[Page 71928]]
145
ASTM F2217-02(2007) Standard Withdrawn and
231 Practice for Coating/
replaced with Adhesive Weight
newer version Determination
146
ASTM F2227-02(2007) Standard Withdrawn and
232 Test Method for Non-
replaced with Destructive Detection of newer version Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method
147
ASTM F2228-02(2007) Standard Withdrawn and
233 Test Method for Non-
replaced with Destructive Detection of newer version Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
167
ASTM F2097-07 Standard Guide Withdrawn and
234 for Design and Evaluation of replaced with Primary Flexible Packaging newer version for Medical Products
168
ASTM F2338-05 Standard Test Relevant
.............. Method for Nondestructive guidance Detection of Leaks in Packages by Vacuum Decay Method
169
ASTM F2391-05 Standard Test Relevant
.............. Method for Measuring Package guidance and Seal Integrity Using Helium as Tracer Gas
170
ASTM F2475-05 Standard Guide Relevant
.............. for Biocompatibility
guidance Evaluation of Medical Device Packaging Materials
193
AAMI/ANSI/ISO 11607-1:2006 Relevant
.............. Packaging for Terminally guidance Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems, 3ed.
194
AAMI/ANSI/ISO 11607-2:2006 Relevant
.............. Packaging for Terminally guidance Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1ed.
196
ASTM F1140-07 Standard Test Withdrawn and
235 Methods for Internal
replaced with Pressurization Failure
newer version Resistance of Unrestrained Packages
197
ASTM F1608:00(2004) Standard Relevant
.............. Test Method for Microbial guidance Ranking of Porous Packaging Materials (Exposure Chamber Method)
198
ASTM F2054-07 Standard Test Withdrawn and
236 Method for Burst Testing of replaced with Flexible Package Seals Using newer version Internal Air Pressurization Within Restraining Plates
199
ASTM D4169-05 Standard
Relevant
.............. Practice for Performance guidance Testing of Shipping Containers and Systems
200
ASTM F88-07 Standard Test Withdrawn and
237 Method for Seal Strength of replaced with Flexible Barrier Materials newer version
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Tissue Engineering
2
ASTM F2103-01(2007)e1
Withdrawn and
12 Standard Guide for
replaced with Characterization and Testing newer version of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
-
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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: 019.
Table 3.
Item No.
Title of Standard
Reference No. & Date
-
Anesthesia
76
Anaesthetic and Respiratory
ISO 26825:2007 Equipment--User-applied Labels for Syringes Containing Drugs Used During Anaesthesia-- Colours, Design and Performance
-
Dental/ ENT
[[Page 71929]]
145
Dentistry--Membrane Materials for
ISO 22803:2004 Guided Tissue Regeneration in Oral and Maxillofacial Surgery-- Contents of a Technical File
146
Dentistry--Metallic Materials for
ISO 22674: 2006 Fixed and Removable Restorations and Appliances
-
General Hospital/ General Plastic Surgery
202
Lasers and Laser-related
ISO 11810-2:2007 Equipment -- Test Method and Classification for the Laser- resistance of Surgical Drapes and/or Patient-protective Covers -- Part 2: Secondary Ignition
-
Ophthalmic
53
Ophthalmic optics--Contact Lenses
ISO 18369-1:2006 -- Part 1: Vocabulary, Classification System and Recommendations for Labeling Specifications
54
Ophthalmic Optics- Contact Lenses-
ISO 18369-4:2006 Part 4: Physicochemical Properties of Contact Lens Materials
55
Ophthalmic implants --
ISO 11979-6:2007 Intraocular Lenses -- Part 6: Shelf-life and Transport Stability
-
Radiology
171
Optics and Photonics -- Microlens
ISO 14880-2:2006 Arrays -- Part 2: Test Methods for Wavefront Aberrations
172
Optics and Photonics -- Microlens
ISO 14880-3:2006 Arrays -- Part 3: Test Methods for Optical Properties Other than Wavefront Aberrations
173
Optics and Photonics -- Microlens
ISO 14880-4:2006 Arrays -- Part 4: Test Methods for Geometrical Properties
174
Optics and Photonics -- Lasers
ISO 13697:2006 and Laser-related Equipment -- Test Methods for Specular Reflectance and Regular Transmittance of Optical Laser Components
175
Optics and Photonics -- Lasers
ISO 24013:2006 and Laser-related Equipment -- Measurement of Phase Retardation of Optical Components for Polarized Laser Radiation
176
Evaluation and Routine Testing in IEC 61223-3-2 Ed. 2.0 Medical Imaging Departments -
(2007) Part 3-2: Acceptance Tests - Imaging Performance of Mammographic X-ray Equipment
-
Sterility
238
Sterilization of Health Care
ANSI/AAMI/ISO11140- Products - Chemical Indicators -
5:2007 Part 5: Class 2 Indicators for Bowie and Dick-type Air Removal Tests
239
Aseptic Processing of Health Care
ISO 13408-3:2006 Products--Part 3: Lyophilization
240
Aseptic Processing of Health Care
ISO 13408-5:2006 Products--Part 5: Sterilization- in-place
241
Aseptic Processing of Health Care
ISO 13408-6:2005 Products--Part 6: Isolator Systems
242
Cleanrooms and Associated
ISO 14644-3:2005 Controlled Environments--Part 3: Test Methods
243
Cleanrooms and Associated
ISO 14644-6:2007 Controlled Environments--Part 6: Vocabulary
244
Cleanrooms and Associated
ISO 14644-8:2006 Controlled Environments - Part 8: Classification of Airborne Molecular Contamination
-
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List of Recognized Standards
FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.
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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
[[Page 71930]]
the device(s) that would be addressed by a declaration of conformity.
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Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of Consensus Standards'' by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this notice announcing ``Modification to the List of Recognized Standards, Recognition List Number: 019'' 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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm .
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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: 019. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register.
Dated: December 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy.
[FR Doc. E7-24580 Filed 12-18-07; 8:45 am]
BILLING CODE 4160-01-S
