[Federal Register Volume 77, Number 145 (Friday, July 27, 2012)]
[Notices]
[Pages 44256-44257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18332]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0630]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Safety Considerations for 510(k) Submissions To Mitigate the 
Risks of Misconnections With Small-Bore Connectors Intended for Enteral 
Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Safety Considerations for 
510(k) Submissions to Mitigate the Risks of Misconnections with Small-
bore Connectors Intended for Enteral Applications.'' The use of common 
connector designs, such as luer connectors, has led to unintended 
connections between devices that have different intended uses and has 
resulted in serious and sometimes fatal consequences to patients. This 
guidance provides recommendations to 510(k) submitters regarding the 
submission expectations regarding design and testing to reduce the risk 
of unintended connections between enteral and nonenteral devices. This 
draft guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 25, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Safety Considerations for 510(k) 
Submissions To Mitigate the Risks of Misconnections With Small-Bore 
Connectors Intended for Enteral Applications'' to the Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the draft guidance 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: Priya Venkataraman-Rao, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. G222, Silver Spring, MD 20993-0002, 
301-796-6243.

I. Background

    Multiple publications regarding patient injury and death from 
tubing and catheter misconnections indicate that reports of 
misconnections have gradually increased in frequency. On July 9, 2010, 
FDA issued a letter to health care professionals, hospital purchasing 
departments, and manufacturers of enteral feeding tubes regarding luer 
lock misconnections. FDA advised manufacturers to assess the risks of 
misconnections for their devices and provide proposed solutions with 
validation for premarket review. At that time, some manufacturers were 
using color coding and labeling to reduce the risk of misconnections; 
others were creating proprietary connectors designed to be incompatible 
with nonenteral devices. However, recent reports of adverse events have 
demonstrated that reliance on color-coding of enteral devices alone 
cannot adequately mitigate the risk of misconnections, especially with 
similarly color-coded PICC (percutaneously inserted central catheter) 
lines on the market.
    This guidance provides updated recommendations to manufacturers on 
the submission requirements for 510(k)s for small-bore connectors used 
in enteral applications. The guidance recommends that 510(k) submitters 
(1) Design and test enteral connectors based on the Association for the 
Advancement of Medical Instrumentation (AAMI)/American National 
Standards Institute (ANSI)/International Organization for 
Standardization (ISO) 80369-1, ``Small-Bore Connectors for Liquids and 
Gases in Healthcare Applications--Part 1: General Requirements'' 
standard; (2) no longer rely strictly on color coding and tagging to 
prevent misconnections; and (3) perform risk assessments to demonstrate 
that the proposed design and testing has effectively mitigated the risk 
of the proposed enteral connector misconnecting to nonenteral devices.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on mitigating 
the risks of misconnections with small-bore connectors intended for 
enteral applications. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To

[[Page 44257]]

receive ``Safety Considerations for 510(k) Submissions To Mitigate the 
Risks of Misconnections With Small-Bore Connectors Intended for Enteral 
Applications,'' you may either send an email request to 
[email protected] to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1784 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073; the collections of information in 21 CFR 
part 812 have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR 56.115 have been approved under OMB control 
number 0910-0130; the collections of information found in 21 CFR part 
814 have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 803 have been approved under 
OMB control number 0910-0437; and the collections of information in 21 
CFR part 801 have been approved under OMB control number 0910-0485.
    The labeling provisions of this draft guidance are not subject to 
review by the Office of Management and Budget because they do not 
constitute a ``collection of information'' under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the recommended 
enteral connector labeling is a ``public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public.'' (see 5 CFR 1320.3(c)(2)).

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. 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.

    Dated: July 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18332 Filed 7-26-12; 8:45 am]
BILLING CODE 4160-01-P