[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27873-27874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11171]


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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: 035

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: 035'' (``Recognition List Number: 035''), 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 VI for the effective date of the 
recognition of standards announced in this document.

ADDRESSES: Submit written requests for single copies of the document 
entitled ``Modifications to the List of Recognized Standards, 
Recognition List Number: 035'' 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 requests, or fax your request to 
301-847-8149.
    Submit electronic or written comments concerning this document or 
concerning recommendations for additional standards for recognition to 
the contact person (see FOR FURTHER INFORMATION CONTACT). This document 
may also be accessed on FDA's Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See 
section V of this document for electronic access to the searchable 
database for the current list of FDA recognized consensus standards, 
including Recognition List Number: 035 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 20993-0002, 301-
796-6287, [email protected].

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 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/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains hypertext 
markup language and portable document format versions of the list of 
FDA Recognized Consensus Standards. Both versions are publicly 
accessible at the Agency's Internet site. See section V 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: 035

    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, using the term 
``Recognition List Number: 035'' to identify these current 
modifications.
    In table 1 of this document, FDA describes 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.

                           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. Radiology
----------------------------------------------------------------------------------------------------------------
12-207.............................  ......................  IEC 60601-2-33 Edition 3.0   Recognition restored
                                                              2010-03, Medical             with transition
                                                              electrical equipment--Part   period.
                                                              2-33: Particular
                                                              requirements for the basic
                                                              safety and essential
                                                              performance of magnetic
                                                              resonance equipment for
                                                              medical diagnosis.
12-208.............................  ......................  IEC 60601-2-22 Third         Recognition restored
                                                              edition 2007-05 Medical      with transition
                                                              electrical equipment--Part   period.
                                                              2-22: Particular
                                                              requirements for basic
                                                              safety and essential
                                                              performance of surgical,
                                                              cosmetic, therapeutic, and
                                                              diagnostic laser equipment.

[[Page 27874]]

 
12-210.............................  ......................  IEC 60601-1-3 Edition 2.0    Recognition restored
                                                              2008-01 Medical electrical   with transition
                                                              equipment--Part 1-3:         period.
                                                              General requirements for
                                                              basic safety and essential
                                                              performance--Collateral
                                                              standard: Radiation
                                                              protection in diagnostic x
                                                              ray equipment.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. 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 our 
Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. We will incorporate the modifications and 
revisions described in this notice into the database and, upon 
publication in the Federal Register, this recognition of consensus 
standards will be effective. We 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, we will no longer announce 
minor revisions to the list of recognized consensus standards such as 
technical contact person, relevant guidance, processes affected, Code 
of Federal Regulations citations, and product codes.

IV. 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.

V. 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: 035'' 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.

VI. Submission of Comments and Effective Date

    Interested persons may submit either electronic or written comments 
concerning this document or concerning recommendations for additional 
standards for recognition to the contact person (see FOR FURTHER 
INFORMATION CONTACT). 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: 035. These 
modifications to the list of recognized standards are effective upon 
publication of this notice in the Federal Register.

    Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11171 Filed 5-14-14; 8:45 am]
BILLING CODE 4160-01-P