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Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 024

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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.

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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.

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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.—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.

II. 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.Start Printed Page 32944

Table 2.—Modifications to the List of Recognized Standards

Old Recognition No.Replacement Recognition No.Title of Standard1Change
A. Dental/ENT
4-1224-187IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment—Part 2-18: Particular requirements for the basic safety and essential performance of endoscope equipmentNewer version with transition period
B. General
5-45-52ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment—Part 1: General requirements for basic safety and essential performanceNewer version with transition period
5-285-53IEC 60601-1-2 Third edition 2007-03 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and testsNewer version with transition period
5-305-54ANSI/AAMI/IEC 60601-1-2:2007 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and testsNewer version with transition period
5-345-53IEC 60601-1-2 Third edition 2007-03 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and testsNewer version with transition period
5-355-54ANSI/AAMI/IEC 60601-1-2:2007 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and testsNewer version with transition period
5-495-55IEC 60601-1-8 Second edition 2006-10 Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsNewer version with transition period
C. General Hospital/General Plastic Surgery
6-96-227ANSI/AAMI/IEC 60601-2-21: 2009 Medical electrical equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmersNewer version with transition period
6-29ANSI/AAMI/IEC 60601-2-19: 2009 Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubatorsNewer version with transition period Refer to recognition no. 6-230
6-32ANSI/AAMI/IEC60601-2-20: 2009 Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubatorsNewer version with transition period Refer to recognition no. 6-231
6-142AAMI/ANSI II36:2004 Medical electrical equipment—Part 2: Particular requirements for safety of baby incubatorsNewer version with transition period. Refer to recognition no. 6-230
6-143AAMI/ANSI II51:2004 Medical electrical equipment—Part 2: Particular requirements for safety of transport incubatorsNewer version with transition period. Refer to recognition no. 6-231
6-1466-227ANSI/AAMI/IEC 60601-2-21:2009 Medical Electrical Equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmersNewer version with transition period
6-182IEC 60601-2-38 1996/Amendment 1:1999 Medical electrical—Part 2-38: Particular requirements for the safety of electrically operated hospital bedsNewer version with transition period. Refer to recognition no. 6-233
6-1976-228IEC 60601-2-2 Edition 5.0 2009-02 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessoriesNewer version with transition period
D. OB-GYN/Gastroenterology
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9-49-60IEC 60601-2-16 Edition 3.0 2008-04 Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipmentNewer version with transition period
9-429-61IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment—Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmentNewer version with transition period
9-469-62IEC 60601-2-2 Edition 5.0 2009-02 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessoriesNewer version with transition period
E. Radiology
12-34IEC 60601-2-7 Second edition 1998-02 Medical electrical equipment—Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generatorsNewer version with transition period. Refer to recognition no. 12-201
12-36IEC 60601-2-9 (1996-10) Medical electrical equipment—Part 2: Particular requirements for the safety of patient contact dosimeters used in radiotherapy with electrically connected radiation detectors—Ed. 2.0Withdrawn
12-6312-202IEC 60601-2-43 Edition 2.0 2010-03 Medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional proceduresNewer version with transition period
12-12012-203IEC 60601-2-44 Edition 3.0 2009-02 Medical electrical equipment—Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomographyNewer version with transition period
12-12612-204IEC 60601-2-28 Edition 2.0 2010-03 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosisNewer version with transition period
12-127IEC 60601-2-32 First edition 1994-03 Medical electrical equipment Part 2: Particular requirements for the safety of associated equipment of X-ray equipmentNewer version with transition period. Refer to recognition no. 12-201
12-14712-205IEC 60601-2-5 Edition 3.0 2009-07 Medical electrical equipment Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipmentNewer version with transition period
12-15212-206IEC 60601-2-1 Edition 3.0 2009-10 Medical electrical equipment Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeVNewer version with transition period
12-18912-207IEC 60601-2-33 Edition 3.0 2010-03 Medical electrical equipment—Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosisNewer version with transition period
12-19712-208IEC 60601-2-22 Third edition 2007-05 Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipmentNewer version with transition period
12-19812-209IEC 60601-2-37 Edition 2.0 2007-08 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipmentNewer version with transition period
12-19912-210IEC 60601-1-3 Edition 2.0 2008-01 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipmentNewer version with transition period
12-20012-211IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment—Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulatorsNewer version with transition period
1 All standard titles in this table conform to the style requirements of the respective organizations.
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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: 024.

Table 3.—New Entries to the List of Recognized Standards

Recognition No.Title of Standard1Reference No. & Date
A. Cardiology
3-78Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometersANSI/AAMI/IEC 80601-2-30:2009
B. General Hospital/General Plastic Surgery
6-229Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessoriesANSI/AAMI/IEC 60601-2-2:2009
6-230Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubatorsANSI/AAMI/IEC 60601-2-19:2009
6-231Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubatorsANSI/AAMI/IEC 60601-2-20:2009
6-232Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurementISO 80601-2-56 First Edition 2009-10-01
6-233Medical electrical equipment—Part 2-52: Particular requirements for the basic safety and essential performance of medical bedsIEC 60601-2-52 Edition 1.0 2009-12
6-234Medical Electrical Equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipmentIEC 60601-2-50 Edition 2.0 2009-03
6-235Medical Electrical Equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipmentANSI/AAMI/IEC 60601-2-50: 2009
6-236Medical electrical equipment—Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screeningIEC 80601-2-59 Edition 1.0 2008-10
6-237CORRIGENDUM 1 Medical electrical equipment—Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screeningIEC 80601-2-59 Edition 1.0 2008-10
6-238Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical useIEC 80601-2-35 Edition 2.0 2009-10
C. OB-GYN/Gastroenterology
9-63Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment CORRIGENDUM 1IEC 60601-2-16 (Third edition—2008)
9-64Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessoriesANSI/AAMI/IEC 60601-2-2:2009
D. Radiology
12-201Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopyIEC 60601-2-54 Edition 1.0 2009-06
1 All standard titles in this table conform to the style requirements of the respective organizations.

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, Start Printed Page 32947at 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: 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.

VII. 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.

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Dated: June 4, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-13874 Filed 6-9-10; 8:45 am]

BILLING CODE 4160-01-S