1997 Food and Drug Administration Modernization Act: Modifications to List of Recognized Standards, Recognition List (Number 024)
Federal Register: June 10, 2010 (Volume 75, Number 111)
Notices
Page 32943-32947
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr10jn10-50
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2004-N-0451
(formerly Docket No. 2004N-0226)
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 024
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: 024'' (Recognition List Number: 024), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
DATES: Submit either electronic or written 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: 024'' to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4617, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests, or fax your request to 301-847-8149. 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.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. 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: 024 modifications and other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301- 796-6574.
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.--Previous Publications of Standard Recognition Lists
February 25, 1998 (63 FR 9561)
November 8, 2005 (70 FR 67713)
October 16, 1998 (63 FR 55617)
March 31, 2006 (71 FR 16313)
July 12, 1999 (64 FR 37546)
June 23, 2006 (71 FR 36121)
November 15, 2000 (65 FR 69022)
November 3, 2006 (71 FR 64718)
May 7, 2001 (66 FR 23032)
May 21, 2007 (72 FR 28500)
January 14, 2002 (67 FR 1774)
September 12, 2007 (72 FR 52142)
October 2, 2002 (67 FR 61893)
December 19, 2007 (72 FR 71924)
April 28, 2003 (68 FR 22391)
September 9, 2008 (73 FR 52358)
March 8, 2004 (69 FR 10712)
March, 18, 2009 (74 FR 11586)
June 18, 2004 (69 FR 34176)
September 8, 2009 (74 FR 46203)
October 4, 2004 (69 FR 59240)
May 5, 2010 (75 FR 24711)
May 27, 2005 (70 FR 30756)
...................................
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.
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Modifications to the List of Recognized Standards, Recognition List
Number: 024
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: 024'' 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.
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Table 2.--Modifications to the List of Recognized Standards
Old Recognition
Replacement
No.
Recognition No.
Title of Standard\1\
Change
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Dental/ENT
4-122
4-187
IEC 60601-2-18 Edition 3.0 2009-08 Medical
Newer version with electrical equipment--Part 2-18: Particular
transition period requirements for the basic safety and essential performance of endoscope equipment
-
General
5-4
5-52
ANSI/AAMI ES60601-1:2005, Medical Electrical
Newer version with
Equipment--Part 1: General requirements for
transition period basic safety and essential performance
5-28
5-53
IEC 60601-1-2 Third edition 2007-03 Medical
Newer version with electrical equipment--Part 1-2: General
transition period requirements for basic safety and essential performance--Collateral standard:
Electromagnetic compatibility--Requirements and tests
5-30
5-54
ANSI/AAMI/IEC 60601-1-2:2007 Medical electrical Newer version with equipment--Part 1-2: General requirements for transition period basic safety and essential performance--
Collateral standard: Electromagnetic compatibility--Requirements and tests
5-34
5-53
IEC 60601-1-2 Third edition 2007-03 Medical
Newer version with electrical equipment--Part 1-2: General
transition period requirements for basic safety and essential performance--Collateral standard:
Electromagnetic compatibility--Requirements and tests
5-35
5-54
ANSI/AAMI/IEC 60601-1-2:2007 Medical electrical Newer version with equipment--Part 1-2: General requirements for transition period basic safety and essential performance--
Collateral standard: Electromagnetic compatibility--Requirements and tests
5-49
5-55
IEC 60601-1-8 Second edition 2006-10 Medical
Newer version with electrical equipment--Part 1-8: General
transition period requirements for basic safety and essential performance--Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
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General Hospital/General Plastic Surgery
6-9
6-227
ANSI/AAMI/IEC 60601-2-21: 2009 Medical
Newer version with electrical equipment--Part 2-21: Particular
transition period requirements for the basic safety and essential performance of infant radiant warmers
6-29
.................. ANSI/AAMI/IEC 60601-2-19: 2009 Medical
Newer version with
Electrical Equipment--Part 2-19: Particular
transition period requirements for the basic safety and
Refer to recognition essential performance of infant incubators
no. 6-230
6-32
.................. ANSI/AAMI/IEC60601-2-20: 2009 Medical
Newer version with
Electrical Equipment--Part 2-20: Particular
transition period requirements for the basic safety and
Refer to recognition essential performance of infant transport
no. 6-231 incubators
6-142
.................. AAMI/ANSI II36:2004 Medical electrical
Newer version with equipment--Part 2: Particular requirements for transition period. safety of baby incubators
Refer to recognition no. 6-230
6-143
.................. AAMI/ANSI II51:2004 Medical electrical
Newer version with equipment--Part 2: Particular requirements for transition period. safety of transport incubators
Refer to recognition no. 6-231
6-146
6-227
ANSI/AAMI/IEC 60601-2-21:2009 Medical
Newer version with
Electrical Equipment--Part 2-21: Particular
transition period requirements for the basic safety and essential performance of infant radiant warmers
6-182
.................. IEC 60601-2-38 1996/Amendment 1:1999 Medical
Newer version with electrical--Part 2-38: Particular requirements transition period. for the safety of electrically operated
Refer to recognition hospital beds
no. 6-233
6-197
6-228
IEC 60601-2-2 Edition 5.0 2009-02 Medical
Newer version with electrical equipment--Part 2-2: Particular
transition period requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
-
OB-GYN/Gastroenterology
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9-4
9-60
IEC 60601-2-16 Edition 3.0 2008-04 Medical
Newer version with electrical equipment--Part 2-16: Particular
transition period requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
9-42
9-61
IEC 60601-2-18 Edition 3.0 2009-08 Medical
Newer version with electrical equipment--Part 2-18: Particular
transition period requirements for the basic safety and essential performance of endoscopic equipment
9-46
9-62
IEC 60601-2-2 Edition 5.0 2009-02 Medical
Newer version with electrical equipment--Part 2-2: Particular
transition period requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
-
Radiology
12-34
.................. IEC 60601-2-7 Second edition 1998-02 Medical
Newer version with electrical equipment--Part 2-7: Particular
transition period. requirements for the safety of high-voltage
Refer to recognition generators of diagnostic X-ray generators
no. 12-201
12-36
.................. IEC 60601-2-9 (1996-10) Medical electrical
Withdrawn equipment--Part 2: Particular requirements for the safety of patient contact dosimeters used in radiotherapy with electrically connected radiation detectors--Ed. 2.0
12-63
12-202
IEC 60601-2-43 Edition 2.0 2010-03 Medical
Newer version with electrical equipment--Part 2-43: Particular
transition period requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
12-120
12-203
IEC 60601-2-44 Edition 3.0 2009-02 Medical
Newer version with electrical equipment--Part 2-44: Particular
transition period requirements for the basic safety and essential performance of X-ray equipment for computed tomography
12-126
12-204
IEC 60601-2-28 Edition 2.0 2010-03 Medical
Newer version with electrical equipment--Part 2-28: Particular
transition period requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
12-127
.................. IEC 60601-2-32 First edition 1994-03 Medical
Newer version with electrical equipment Part 2: Particular
transition period. requirements for the safety of associated
Refer to recognition equipment of X-ray equipment
no. 12-201
12-147
12-205
IEC 60601-2-5 Edition 3.0 2009-07 Medical
Newer version with electrical equipment Part 2-5: Particular
transition period requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
12-152
12-206
IEC 60601-2-1 Edition 3.0 2009-10 Medical
Newer version with electrical equipment Part 2-1: Particular
transition period requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
12-189
12-207
IEC 60601-2-33 Edition 3.0 2010-03 Medical
Newer version with electrical equipment--Part 2-33: Particular
transition period requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
12-197
12-208
IEC 60601-2-22 Third edition 2007-05 Medical
Newer version with electrical equipment--Part 2-22: Particular
transition period requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
12-198
12-209
IEC 60601-2-37 Edition 2.0 2007-08 Medical
Newer version with electrical equipment--Part 2-37: Particular
transition period requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
12-199
12-210
IEC 60601-1-3 Edition 2.0 2008-01 Medical
Newer version with electrical equipment--Part 1-3: General
transition period requirements for basic safety and essential performance--Collateral Standard: Radiation protection in diagnostic X-ray equipment
12-200
12-211
IEC 60601-2-29 Edition 3.0 2008-06 Medical
Newer version with electrical equipment--Part 2-29: Particular
transition period requirements for the basic safety and essential performance of radiotherapy simulators
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
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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: 024.
Table 3.--New Entries to the List of Recognized Standards
Recognition
Reference
No.
Title of Standard\1\
No. & Date
-
Cardiology
3-78
Medical electrical equipment--Part 2-30:
ANSI/AAMI/
Particular requirements for the basic
IEC 80601-2- safety and essential performance of
30:2009 automated noninvasive sphygmomanometers
-
General Hospital/General Plastic Surgery
6-229
Medical electrical equipment--Part 2-2:
ANSI/AAMI/
Particular requirements for the basic
IEC 60601-2- safety and essential performance of high 2:2009 frequency surgery equipment and high frequency surgical accessories
6-230
Medical Electrical Equipment--Part 2-19:
ANSI/AAMI/
Particular requirements for the basic
IEC 60601-2- safety and essential performance of
19:2009 infant incubators
6-231
Medical Electrical Equipment--Part 2-20:
ANSI/AAMI/
Particular requirements for the basic
IEC 60601-2- safety and essential performance of
20:2009 infant transport incubators
6-232
Medical electrical equipment--Part 2-56:
ISO 80601-2-
Particular requirements for basic safety 56 First and essential performance of clinical
Edition thermometers for body temperature
2009-10-01 measurement
6-233
Medical electrical equipment--Part 2-52:
IEC 60601-2-
Particular requirements for the basic
52 Edition safety and essential performance of
1.0 2009-12 medical beds
6-234
Medical Electrical Equipment--Part 2-50:
IEC 60601-2-
Particular requirements for the basic
50 Edition safety and essential performance of
2.0 2009-03 infant phototherapy equipment
6-235
Medical Electrical Equipment--Part 2-50:
ANSI/AAMI/
Particular requirements for the basic
IEC 60601-2- safety and essential performance of
50: 2009 infant phototherapy equipment
6-236
Medical electrical equipment--Part 2-59:
IEC 80601-2-
Particular requirements for the basic
59 Edition safety and essential performance of
1.0 2008-10 screening thermographs for human febrile temperature screening
6-237
CORRIGENDUM 1 Medical electrical
IEC 80601-2- equipment--Part 2-59: Particular
59 Edition requirements for the basic safety and
1.0 2008-10 essential performance of screening thermographs for human febrile temperature screening
6-238
Medical electrical equipment--Part 2-35:
IEC 80601-2-
Particular requirements for the basic
35 Edition safety and essential performance of
2.0 2009-10 heating devices using blankets, pads or mattresses and intended for heating in medical use
-
OB-GYN/Gastroenterology
9-63
Medical electrical equipment--Part 2-16:
IEC 60601-2-
Particular requirements for basic safety 16 (Third and essential performance of
edition--20 haemodialysis, haemodiafiltration and
08) haemofiltration equipment CORRIGENDUM 1
9-64
Medical electrical equipment--Part 2-2:
ANSI/AAMI/
Particular requirements for the basic
IEC 60601-2- safety and essential performance of high 2:2009 frequency surgery equipment and high frequency surgical accessories
-
Radiology
12-201
Medical electrical equipment--Part 2-54:
IEC 60601-2-
Particular requirements for the basic
54 Edition safety and essential performance of X-ray 1.0 2009-06 equipment for radiography and radioscopy
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
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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.
-
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,
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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.
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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: 024'' will be available on the CDRH home page. You may access the CDRH home page at http:// www.fda.gov/MedicalDevices.
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/MedicalDevices/
DeviceRegulationandGuidance/Standards.
This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
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Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. 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: 024. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register.
Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
FR Doc. 2010-13874 Filed 6-9-10; 8:45 am
BILLING CODE 4160-01-S
