[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, [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 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
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A. General I (ES/EMC)
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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.
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B. General II (ES/EMC)
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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.
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\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.
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\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
[email protected]. 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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