[Federal Register Volume 78, Number 151 (Tuesday, August 6, 2013)]
[Notices]
[Pages 47712-47714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451] (formerly 2004N-0226)


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 032

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). Specifically, this publication 
announces the addition of a list of recognized standards that are 
relevant to interoperability of medical devices. This publication, 
entitled ``Modifications to the List of Recognized Standards, 
Recognition List Number: 032'' (Recognition List Number: 032), 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 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: 032'' 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, Silver Spring, MD 
20993. Send two self-addressed adhesive labels 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 email: 
[email protected]. This document may also be accessed on FDA's 
Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI for 
electronic access to the searchable database for the current list of 
FDA recognized consensus standards, including Recognition List Number: 
032 modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-
6287.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C 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, can be accessed at http://
www.fda.gov/MedicalDevices/

[[Page 47713]]

DeviceRegulationandGuidance/Standards/ucm123792.htm.
    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 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: 032

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency will recognize for 
use in premarket submissions 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: 032'' to identify these current 
modifications.
    In section III, FDA lists modifications the Agency is making that 
involve the initial addition of standards not previously recognized by 
FDA.

III. Listing of New Entries

    In table 1, FDA provides the listing of new entries and consensus 
standards added as modifications to the list of recognized standards 
under Recognition List Number: 032.

                            Table 1--New Entries to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
      Recognition No.                       Title of standard \1\                     Reference No. and date
----------------------------------------------------------------------------------------------------------------
                                              Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-38......................  Application of risk management for IT networks       IEC 80001-1 Edition 1.0 2010-
                              incorporating medical devices--Part 1: Roles,        10
                              responsibilities and activities.
13-39......................  Application of risk management for IT networks       ANSI/AAMI/IEC 80001-1:2010
                              incorporating medical devices--Part 1: Roles,
                              responsibilities and activities.
13-40......................  Application of risk management for IT networks       IEC/TR 80001-2-1 Edition 1.0
                              incorporating medical devices--Part 2-1: Step-by-    2012-07
                              step risk management of medical IT networks--
                              Practical applications and examples.
13-41......................  Application of risk management for IT networks       ANSI/AAMI/IEC TIR80001-2-
                              incorporating medical devices--Part 2-1: Step by     1:2012
                              step risk management of medical IT networks;
                              Practical applications and examples.
13-42......................  Application of risk management for IT networks       IEC/TR 80001-2-2 Edition 1.0
                              incorporating medical devices--Part 2-2: Guidance    2012-07
                              for the disclosure and communication of medical
                              device security needs, risks and controls.
13-43......................  Application of risk management for IT networks       ANSI/AAMI/IEC TIR80001-2-
                              incorporating medical devices--Part 2-2: Guidance    2:2012
                              for the disclosure and communication of medical
                              device security needs, risks and controls.
13-44......................  Application of risk management for IT networks       IEC/TR 80001-2-3 Edition 1.0
                              incorporating medical devices--Part 2-3: Guidance    2012-07
                              for wireless networks.
13-45......................  Application of risk management for IT networks       ANSI/AAMI/IEC TIR80001-2-
                              incorporating medical devices--Part 2-3: Guidance    3:2012
                              for wireless networks.
13-46......................  Medical Devices and Medical Systems--Essential       ASTM F2761-09
                              safety requirements for equipment comprising the
                              patient-centric integrated clinical environment
                              (ICE)--Part 1: General requirements and conceptual
                              model.
13-47......................  Health informatics--Point-of-care medical device     ISO/IEEE 11073-10101 First
                              communication--Part 10101: Nomenclature.             edition 2004-12-15
13-48......................  Health informatics--Point-of-care medical device     ISO/IEEE 11073-10201 First
                              communication--Part 10201: Domain information        edition 2004-12-15
                              model.
13-49......................  Health informatics--Point-of-care medical device     ISO/IEEE 11073-20101 First
                              communication--Part 20101: Application Profiles--    edition 2004-12-15
                              Base Standard.
13-50......................  Health informatics--Personal health device           ISO/IEEE 11073-20601 First
                              communication--Part 20601: Application profile--     edition 2010-05-01
                              Optimized exchange protocol.
13-51......................  Health informatics--Personal health device           IEEE Std 11073-20601a-2010
                              communication--Part 20601: Application profile--
                              Optimized Exchange Protocol Amendment 1.
13-52......................  Health informatics--Point-of-care medical device     ISO/IEEE 11073-10408 First
                              communication--Part 10408: Device specialization--   edition 2010-05-01
                              Thermometer.
13-53......................  Health informatics--Point-of-care medical device     ISO/IEEE 11073-10415 First
                              communication--Part 10415: Device specialization--   edition 2010-05-01
                              Weighing scale.
13-54......................  Health informatics--Personal health device           ISO/IEEE 11073-10404 First
                              communication--Part 10404: Device specialization--   edition 2010-05-01
                              Pulse oximeter.
13-55......................  Health informatics--Personal health device           IEEE Std 11073-10421-2010
                              communication--Part 10421: Device specialization--
                              Peak expiratory flow monitor (peak flow).
13-56......................  Health informatics--Personal health device           IEEE Std 11073-10406-2011
                              communication--Part 10406: Device specialization--
                              Basic electrocardiograph (ECG) (1- to 3-lead ECG).
13-57......................  Health informatics--Personal health device           ISO/IEEE 11073-10407 First
                              communication--Part 10407: Device specialization--   edition 2010-05-01
                              Blood pressure monitor.
13-58......................  Health informatics--Personal health device           ISO/IEEE 11073-10417 First
                              communication--Part 10417: Device specialization--   edition 2010-05-01
                              Glucose meter.
13-59......................  Systems and software engineering--Systems and        ISO/IEC 15026-4 First edition
                              software assurance--Part 4: Assurance in the life    2012-10-01
                              cycle.
13-60......................  Industrial communication networks--Network and       IEC/TS 62443-1-1 Edition 1.0
                              system security--Part 1-1: Terminology, concepts     2009-07
                              and models.

[[Page 47714]]

 
13-61......................  Industrial communication networks--Network and       IEC 62443-2-1 Edition 1.0 2010-
                              system security--Part 2-1: Establishing an           11
                              industrial automation and control system security
                              program.
13-62......................  Industrial communication networks--Network and       IEC/TR 62443-3-1 Edition 1.0
                              system security--Part 3-1: Security technologies     2009-07
                              for industrial automation and control systems.
----------------------------------------------------------------------------------------------------------------
\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 revisions described into the database and, upon publication in the 
Federal Register, this recognition of consensus standards will be 
effective. FDA will announce additional modifications and revisions to 
the list of recognized consensus standards, as needed, in the Federal 
Register once a year, or more often, if necessary. Beginning with 
Recognition List Number: 033, FDA will no longer be announcing minor 
revisions to the list of recognized consensus standards such as 
technical contact person, relevant guidance, processes affected, CFR 
citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under section 514 of the FD&C 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. The Center for Devices and 
Radiological Health (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: 032'' 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'' 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. 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: 032. These modifications to the list of recognized standards 
are effective upon publication of this notice in the Federal Register.

    Dated: July 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19020 Filed 8-5-13; 8:45 am]
BILLING CODE 4160-01-P