[Federal Register Volume 79, Number 201 (Friday, October 17, 2014)]
[Notices]
[Pages 62447-62449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24714]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 037

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''). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 037'' (``Recognition List Number: 037''), 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 for the effective date of the 
recognition of standards announced in this document.

ADDRESSES: An electronic copy of Recognition List Number: 037 is 
available on the Internet 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: 
037 modifications and other standards related information.
    Submit written requests for single copies of the document entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 037'' to the Division of Industry and Consumer Education, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver 
Spring, MD 20993-0002. Send two self-addressed adhesive labels to 
assist that office in processing your request, or fax your request to 
301-847-8149.
    Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

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, standards@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (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 we would implement our 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/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains HTML and 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: 037

    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. We 
will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the Agency's searchable database. We will use 
the term ``Recognition List Number: 037'' to identify these current 
modifications.
    In Table 1, we describe the following modifications: (1) The 
withdrawal of standards and their replacement by others, if applicable, 
(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.

[[Page 62448]]



                           Table 1--Modifications to the List of Recognized Standards
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                                         Replacement
        Old recognition No.            recognition No.          Title of standard \1\              Change
----------------------------------------------------------------------------------------------------------------
                                              A. General I (ES/EMC)
----------------------------------------------------------------------------------------------------------------
5-90..............................  .....................  ISO 15223-1 Second edition 2012- Extent of
                                                            07-01 Medical devices--Symbols   recognition.
                                                            to be used with medical device
                                                            labels, labeling, and
                                                            information to be supplied--
                                                            Part 1: General requirements.
5-91..............................  .....................  AAMI/ANSI/ISO 15223-1:2012       Extent of
                                                            Medical devices--Symbols to be   recognition.
                                                            used with medical devices
                                                            labels, labeling, and
                                                            information to be supplied--
                                                            Part 1: General requirements.
----------------------------------------------------------------------------------------------------------------
                                             B. General II (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-1..............................  .....................  IEC 60601-1-2 Edition 3: 2007-   Extent of
                                                            03 Medical Electrical            recognition and
                                                            Equipment--Part 1-2: General     transition period.
                                                            Requirements for Basic Safety
                                                            and Essential Performance--
                                                            Collateral Standard:
                                                            Electromagnetic Compatibility--
                                                            Requirements and Tests.
19-2..............................  .....................  ANSI/AAMI/IEC 60601-1-2:2007/    Extent of
                                                            (R)2012 Medical Electrical       recognition and
                                                            Equipment--Part 1-2: General     transition period.
                                                            requirements for basic safety
                                                            and essential performance--
                                                            Collateral Standard:
                                                            Electromagnetic compatibility--
                                                            requirements and tests.
19-8..............................  .....................  IEC 60601-1-2 Edition 4.0 2014-  Transition period
                                                            02 Medical electrical            extended.
                                                            equipment--Part 1-2: General
                                                            requirements for basic safety
                                                            and essential performance--
                                                            Collateral Standard:
                                                            Electromagnetic disturbances--
                                                            Requirements and tests.
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                                             C. In Vitro Diagnostics
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7-246.............................  .....................  CLSI POCT12-A3 Point-of-Care     Withdrawn.
                                                            Blood Glucose Testing in Acute
                                                            and Chronic Care Facilities;
                                                            Approved Guideline--Third
                                                            Edition.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In Table 2 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: 037.

        Table 2--New Entries to the List of Recognized Standards
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                                                          Reference No.
       Recognition No.          Title of standard \1\        and date
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                         A. General II (ES/EMC)
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19-12.......................  Medical electrical         ANSI/AAMI/IEC
                               equipment--Part 1-2:       60601-1-2:2014
                               General requirements for   .
                               basic safety and
                               essential performance--
                               Collateral Standard:
                               Electromagnetic
                               disturbances--Requiremen
                               ts and tests.
19-13.......................  Secondary cells and        IEC 62133
                               batteries containing       Edition 2.0
                               alkaline or other non-     2012-12.
                               acid electrolytes--
                               Safety requirements for
                               portable sealed
                               secondary cells, and for
                               batteries made from
                               them, for use in
                               portable applications
                               [Including: Corrigendum
                               1 (2013)].
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                       B. OB-GYN/Gastroenterology
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9-95........................  Enteral Feeding Catheters  EN 1615:2000.
                               and Enteral Giving Sets
                               for Single Use and their
                               Connectors--Design and
                               Testing.
9-96........................  Catheters Other Than       EN 1618:1997.
                               Intravascular Catheters--
                               Test Methods for Common
                               Properties.
------------------------------------------------------------------------
\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 in this notice into the database and, upon 
publication in the Federal Register, this recognition of

[[Page 62449]]

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 033, FDA no longer 
announces minor revisions to the list of recognized consensus standards 
such as technical contact person, devices affected, processes affected, 
Code of Federal Regulations 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 
standards@cdrh.fda.gov. 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, http://www.fda.gov/MedicalDevices, 
includes a link to standards-related documents including the guidance 
and the current list of recognized standards. After publication in the 
Federal Register, this notice announcing ``Modification to the List of 
Recognized Standards, Recognition List Number: 037'' will be available 
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    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.

VII. Submission of Comments and Effective Date

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. 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: 037. These 
modifications to the list of recognized standards are effective upon 
publication of this notice in the Federal Register.

    Dated: October 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24714 Filed 10-16-14; 8:45 am]
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