[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Notices]
[Pages 71434-71435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28267]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0194]


Infusion Pumps Total Product Life Cycle; Guidance for Industry 
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: Food and Drug Administration (FDA) is announcing the 
availability of the final guidance entitled, ``Infusion Pumps Total 
Product Life Cycle; Guidance for Industry and FDA Staff.'' The 
recommendations in this guidance are intended to improve the safety and 
effectiveness of these devices. This guidance also describes 
considerations in preparing premarket submissions for infusion pumps 
and identifies device features that manufacturers should address 
throughout the total product life cycle.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Infusion Pumps Total Product Life Cycle; Guidance for Industry and 
FDA Staff'' to the Office of the Center Director, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.
    Submit electronic comments on the 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: Alan Stevens, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2561, Silver Spring, MD 20993-0002, 301-796-6294.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has evaluated a broad spectrum of infusion pumps across 
manufacturers and has encountered common problems with device software, 
human factors, reliability, and manufacturing. Based on an evaluation 
of reported adverse events and recalls, FDA believes that many injuries 
and adverse events may be avoided by improving the design verification 
and validation processes for infusion pump devices.
    The most frequently reported infusion pump device problems are: 
Software error messages, human factors (which include, but are not 
limited to, use error), broken components, battery failure, alarm 
failure, over-infusion, and under-infusion. Subsequent analyses 
revealed that many of these design problems could be corrected during 
the design validation and verification processes.
    The Agency believes that this guidance provides recommendations 
that will help mitigate observed risk and reduce potential risk 
associated with infusion pumps. One method of improving the safety of 
infusion pumps is the inclusion of safety assurance cases as part of 
the premarket submissions for new, changed, or modified infusion pumps 
submitted by device manufacturers. This guidance explains the Agency's 
current thinking and provides recommendations on information to submit 
through the safety assurance case framework and postmarket surveillance 
of infusion pumps.
    In April 2010, the Agency issued the special control draft guidance 
entitled ``Draft Guidance for Industry and FDA Staff: Total Product 
Life Cycle: Infusion Pump--Premarket Notification [510(k)] 
Submissions'' (Ref. 1). The Agency has reviewed the comments submitted 
for the 2010 guidance and has incorporated most of the recommendations 
in this final guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
Agency's current thinking on infusion pumps. 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 guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Total Product Life Cycle: 
Infusion Pumps; Guidance for Industry and FDA Staff'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 1780 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. This 
guidance also refers to previously approved information collections 
found in FDA regulations. The collections of information in 21 CFR part 
803 are approved under OMB control number 0910-0437; the collections of 
information in 21 CFR part 801 are approved under OMB control number 
0910-0485; the collections of information in 21 CFR part 812 are 
approved under OMB control number 0910-0078; the collections of 
information in 21 CFR part 807, subpart E are approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
820 are approved under OMB control number 0910-0073; the collections of 
information in 21 CFR part 822 are under OMB control number 0910-0449; 
the collections of information in 21 CFR 56.115 are approved under OMB 
control number 0910-0130; and the collections of information for safety 
assurance cases are approved under OMB control number 0910-0766.

V. Comments

    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.

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VI. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES), and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this reference section, but we are not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

1. The FDA guidance entitled ``Draft Guidance for Industry and FDA 
Staff: Total Product Life Cycle: Infusion Pump--Premarket Notification 
[510(k)] Submissions,'' available at http://www.fda.gov/medicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm206153.htm.

    Dated: November 25, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28267 Filed 12-1-14; 8:45 am]
BILLING CODE 4164-01-P