Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 019
Federal RegisterDec 19, 2007
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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: 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:
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 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
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: 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 No.
Standard
Change
Replacement Item No.
A. Anesthesia
11
IEC 60601-3-1:1996-08 Medical Electrical Equipment - Part 3-1: Essential Performance Requirement for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring Equipment
Title Change
Contact person
18
ISO 8359:1996 Oxygen Concentrators for Medical Use - Safety Requirements
Contact person
51
ASTM F1100-90(1997) Standard Specification for Ventilators Intended for Use in Critical Care
Contact person
Relevant guidance
57
ASTM F1101-90(2003)e1 Standard Specification for Ventilators Intended for Use During Anesthesia
Contact person
59
ASTM F1456-01 Standard Specification for Minimum Performance and Safety Requirements for Capnometers
Relevant guidance
60
IEC 60601-2-12:(2001-10) Medical Electrical Equipment - Part 2-12: Particular Requirements for the Safety of Lung Ventilators - Critical Care Ventilators
Contact person
Relevant guidance
61
IEC 60601-2-13(2003-05):, Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
Relevant guidance
65
ISO 21647: 2004 Medical Electrical Equipment - Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors
Title Change
Relevant guidance
69
ASTM F1464-93(2005) Standard Specification for Oxygen Concentrators for Domiciliary Use
Contact person
70
ASTM F 1246-91 (2005) Standard Specification for Electrically Powered Home Care Ventilators, Part 1 - Positive-Pressure Ventilators and Ventilator Circuits
Contact person
Relevant guidance
71
ISO 10651-5:2006 Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-powered Emergency Resuscitators
Contact person
B. General
20
ASTM F1140:1988: Standard Test Method for Failure Resistance of Unrestrained and Nonrigid Packages for Medical Applications
Withdrawn
C. General Hospital/General Plastic Surgery
21
ISO 10555-3: 1996 Sterile, Single-use Intravascular Catheters - Part 3: Central Venous Catheters
Withdrawn duplicate
171
81
ASTM E1061-01(2007) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
Withdrawn and replaced with newer version
200
111
IEC 60601-2-38: 1996 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds
Withdrawn duplicate
182
117
ASTM F2172-02:, Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
Contact person
121
ISO 8536-2-2001 Infusion Equipment for Medical Use - Part 2: Closures for Infusion Bottles
Withdrawn duplicate
173
126
ISO 8536-4:2007 Infusion Equipment for Medical Use -- Part 4: Infusion Sets for Single-use, Gravity Feed
Withdrawn and replaced with newer version
201
162
ISO 8536-1:2000/Amendment 1:2004 Infusion Equipment for Medical Use - Part 1: Infusion Glass Bottles
Withdrawn duplicate
172
D. In Vitro Diagnostics
31
CLSI H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition
Withdrawn and replaced with newer version
130
E. Materials
3
ASTM F90-07 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
Withdrawn and replaced with newer version
145
30
ASTM F1537-07 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Withdrawn and replaced with newer version
152
41
ASTM F2066-07 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
Withdrawn and replaced with newer version
146
42
ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
Withdrawn and replaced with newer version
153
45
ASTM F562-07 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
Withdrawn and replaced with newer version
147
48
ASTM F899-07 Standard Specification for Stainless Steel for Surgical Instruments
Withdrawn and replaced with newer version
148
56
ISO 5832-1:2007 Implants for Surgery -- Metallic Materials -- Part 1: Wrought Stainless Steel
Withdrawn and replaced with newer version
149
62
ISO 5832-9:2007 Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel
Withdrawn and replaced with newer version
150
64
ISO 5832-12:2007 Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy
Withdrawn and replaced with newer version
151
F. OB-GYN/Gastroenterology
5
IEC 60601-2-18 (1996) Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment
Withdrawn duplicate
42
G. Ophthalmic
35
ISO 10939:2007 Ophthalmic Instruments -- Slit-lamp Microscopes
Contact person
37
ISO 10942:2006 Ophthalmic Instruments -- Direct ophthalmoscopes
Contact person
38
ISO 10943:2006 Ophthalmic Instruments -- Indirect ophthalmoscopes
Contact person
39
ISO 12865:2006 Ophthalmic Instruments -- Retinoscopes
Contact person
51
ISO 15004-2:2007 Ophthalmic Instruments—Fundamental Requirements and Test Methods Part 2: Light Hazard Protection
Contact person
H. Radiology
7
IEC / ISO 10918-1:1994 Information Technology--Digital Compression and Coding of Continuous-tone Still Images - Part 1: Requirements and Guidelines
Withdrawn duplicate
150
76
NU 2-2007 Performance Measurements of Positron Emission Tomographs
Withdrawn and replaced with newer version
167
84
IEC 60825-1 Ed. 2.0 (2007) Safety of Laser Products - Part 1: Equipment Classification and Requirements
Withdrawn and replaced with newer version
168
85
IEC 60601-2-22 Ed. 3.0 (2007) Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment
Withdrawn and replaced with newer version
169
90
IEC 60601-2-1 (1998-06) Medical Electrical Equipment - Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV
Withdrawn duplicate
152
102
ANSI / IESNA RP-27.2-2000 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
Contact person
103
ANSI / IESNA RP-27.3-1996 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
Contact person
112
ISO 11670:2003 Lasers and Laser-related Equipment - Test Methods for Laser Beam Parameters - Beam Positional Stability
Withdrawn duplicate
156
114
ISO 13694:2000 Optics and Optical Instruments - Lasers and Laser-related Equipment - Test Methods for Laser Beam Power (energy) Density Distribution
Withdrawn duplicate
157
119
NEMA PS 3.1 - 3.18 (2007) Digital Imaging and Communications in Medicine (DICOM) Set
Withdrawn and replaced with newer version
170
153
ANSI / IESNA RP-27.1-2005 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
Contact person
I. Software/Informatics
4
ANSI/UL 1998 Software in Programmable Components
Relevant guidance
5
IEC 60601-3-1:1996-08 Medical electrical equipment - Part 3-1: Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
Relevant guidance
8
IEC 62304 Ed. 1.0 Medical device software - Software life cycle processes
Relevant guidance
J. Sterility
25
ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health Care Products - Ethylene oxide - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
Withdrawn and replaced with newer version
228
63
ASTM F1886: 1998 (2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
Relevant guidance
64
ASTM F1929:1998 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Relevant guidance
86
ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Withdrawn and replaced with newer version
229
120
ASTM D3078:2002 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
Relevant guidance
136
AAMI/ANSI ST67:2003 Sterilization of Health Care Products - Requirements for Products Labeled 'Sterile' 1st edition
Relevant guidance
144
ASTM F2203-02(2007) Standard Test Method for Linear Measurement Using Precision Steel Rule
Withdrawn and replaced with newer version
230
145
ASTM F2217-02(2007) Standard Practice for Coating/Adhesive Weight Determination
Withdrawn and replaced with newer version
231
146
ASTM F2227-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO
2
Tracer Gas Method
Withdrawn and replaced with newer version
232
147
ASTM F2228-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO
2
Tracer Gas Method
Withdrawn and replaced with newer version
233
167
ASTM F2097-07 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Withdrawn and replaced with newer version
234
168
ASTM F2338-05 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
Relevant guidance
169
ASTM F2391-05 Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer Gas
Relevant guidance
170
ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
Relevant guidance
193
AAMI/ANSI/ISO 11607-1:2006 Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems, 3ed.
Relevant guidance
194
AAMI/ANSI/ISO 11607-2:2006 Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1ed.
Relevant guidance
196
ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
Withdrawn and replaced with newer version
235
197
ASTM F1608:00(2004) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
Relevant guidance
198
ASTM F2054-07 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
Withdrawn and replaced with newer version
236
199
ASTM D4169-05 Standard Practice for Performance Testing of Shipping Containers and Systems
Relevant guidance
200
ASTM F88-07 Standard Test Method for Seal Strength of Flexible Barrier Materials
Withdrawn and replaced with newer version
237
K. Tissue Engineering
2
ASTM F2103-01(2007)e1 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
Withdrawn and replaced with newer version
12
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: 019.
Table 3.
Item No.
Title of Standard
Reference No. & Date
A. Anesthesia
76
Anaesthetic and Respiratory Equipment—User-applied Labels for Syringes Containing Drugs Used During Anaesthesia—Colours, Design and Performance
ISO 26825:2007
B. Dental/ ENT
145
Dentistry—Membrane Materials for Guided Tissue Regeneration in Oral and Maxillofacial Surgery—Contents of a Technical File
ISO 22803:2004
146
Dentistry—Metallic Materials for Fixed and Removable Restorations and Appliances
ISO 22674: 2006
C. General Hospital/ General Plastic Surgery
202
Lasers and Laser-related Equipment -- Test Method and Classification for the Laser-resistance of Surgical Drapes and/or Patient-protective Covers -- Part 2: Secondary Ignition
ISO 11810-2:2007
D. Ophthalmic
53
Ophthalmic optics—Contact Lenses -- Part 1: Vocabulary, Classification System and Recommendations for Labeling Specifications
ISO 18369-1:2006
54
Ophthalmic Optics- Contact Lenses- Part 4: Physicochemical Properties of Contact Lens Materials
ISO 18369-4:2006
55
Ophthalmic implants -- Intraocular Lenses -- Part 6: Shelf-life and Transport Stability
ISO 11979-6:2007
E. Radiology
171
Optics and Photonics -- Microlens Arrays -- Part 2: Test Methods for Wavefront Aberrations
ISO 14880-2:2006
172
Optics and Photonics -- Microlens Arrays -- Part 3: Test Methods for Optical Properties Other than Wavefront Aberrations
ISO 14880-3:2006
173
Optics and Photonics -- Microlens Arrays -- Part 4: Test Methods for Geometrical Properties
ISO 14880-4:2006
174
Optics and Photonics -- Lasers and Laser-related Equipment -- Test Methods for Specular Reflectance and Regular Transmittance of Optical Laser Components
ISO 13697:2006
175
Optics and Photonics -- Lasers and Laser-related Equipment -- Measurement of Phase Retardation of Optical Components for Polarized Laser Radiation
ISO 24013:2006
176
Evaluation and Routine Testing in Medical Imaging Departments - Part 3-2: Acceptance Tests - Imaging Performance of Mammographic X-ray Equipment
IEC 61223-3-2 Ed. 2.0 (2007)
F. Sterility
238
Sterilization of Health Care Products - Chemical Indicators - Part 5: Class 2 Indicators for Bowie and Dick-type Air Removal Tests
ANSI/AAMI/ISO11140-5:2007
239
Aseptic Processing of Health Care Products—Part 3: Lyophilization
ISO 13408-3:2006
240
Aseptic Processing of Health Care Products—Part 5: Sterilization-in-place
ISO 13408-5:2006
241
Aseptic Processing of Health Care Products—Part 6: Isolator Systems
ISO 13408-6:2005
242
Cleanrooms and Associated Controlled Environments—Part 3: Test Methods
ISO 14644-3:2005
243
Cleanrooms and Associated Controlled Environments—Part 6: Vocabulary
ISO 14644-6:2007
244
Cleanrooms and Associated Controlled Environments - Part 8: Classification of Airborne Molecular Contamination
ISO 14644-8:2006
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 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
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
.
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: 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
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