[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7617-7619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02801]
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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: 039
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 safety considerations to mitigate the risks of
misconnections with small-bore connectors intended for enteral
applications. This publication, entitled ``Modifications to the List of
Recognized Standards, Recognition List Number: 039'' (``Recognition
List Number: 039''), 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: An electronic copy of Recognition List Number: 039 is
available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section V for
electronic access to the searchable database for the current list of
FDA recognized consensus standards, including Recognition List Number:
039 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: 039'' to the Division of Industry and Consumer Education,
Center for Devices and Radiological Health, Food and Drug
[[Page 7618]]
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 V 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. Listing of New Entries
In table 1 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: 039. Specifically,
this publication announces the addition of a list of recognized
standards that are relevant to safety considerations to mitigate the
risks of misconnections with small-bore connectors intended for enteral
applications. Elsewhere in this issue of the Federal Register, we are
publishing a notice of availability of the guidance document entitled
``Safety Considerations to Mitigate the Risks of Misconnections With
Small-Bore Connectors Intended for Enteral Applications.'' This
guidance provides recommendations to manufacturers regarding the
expectations for design and testing of small-bore connectors intended
for enteral applications (``enteral devices''). FDA is making these
recommendations to reduce the risk of unintended connections between
enteral and non-enteral devices.
Table 1--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 I (Quality Systems/Risk Management)
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5-93.......................... Small-bore connectors AAMI/CN3:2014
for liquids and gases (PS).
in healthcare
applications--Part 3:
Connectors for
enteral applications.
5-94.......................... Small-bore connectors AAMI/CN20:2014
for liquids and gases (PS).
in healthcare
applications--Part
20: Common test
methods.
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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
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 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.
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
[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.
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, 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
[[Page 7619]]
Recognized Standards, Recognition List Number: 039'' will be available
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.
VI. 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: 039. These
modifications to the list of recognized standards are effective upon
publication of this notice in the Federal Register.
Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02801 Filed 2-10-15; 8:45 am]
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