[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
------------------------------------------------------------------------
                                                          Reference No.
        Recognition No.          Title of standard \1\      and date
------------------------------------------------------------------------
             A. General I (Quality Systems/Risk Management)
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
\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]
BILLING CODE 4164-01-P