[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
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A. Radiology
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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.
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\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]
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