[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Notices]
[Pages 21632-21634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9209]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry and Food and Drug Administration 
Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification 
[510(k)] Submissions; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance document entitled ``Total Product 
Life Cycle: Infusion Pump--Premarket Notification [510(k)] 
Submissions.'' The recommendations in this guidance are intended to 
improve the safety and effectiveness of these devices. This draft 
guidance is not final nor is it in effect at this time. Elsewhere in 
this issue of the Federal Register, FDA is announcing a public meeting 
regarding external infusion pumps.

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by July 26, 2010. Submit written or electronic comments on the 
collection of information by June 25, 2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Total Product Life Cycle: Infusion Pump--
Premarket Notification [510(k)] Submissions'' 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    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. 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 seen an increase in the number and severity of infusion 
pump recalls. Analyses of medical device reports (MDRs) revealed device 
problems that appear to be a result of faulty design. Between January 
1, 2005, and December 31, 2009, FDA received over 56,000 MDRs 
associated with the use of infusion pumps. Of these reports, 
approximately 1 percent were reported as deaths, 32 percent were 
reported as serious injuries, and 64 percent were reported as 
malfunctions.
    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. In some reports, the 
manufacturer was unable to determine or identify the problem and 
reported the problem as ``unknown.'' Subsequent root cause analyses 
revealed that many of these design problems were foreseeable and, 
therefore, preventable.
    After evaluating a broad spectrum of infusion pumps across 
manufacturers, FDA has concluded there are numerous, systemic problems 
with device design, manufacturing, and adverse event reporting. The 
agency believes that the draft guidance provides recommendations that 
will help mitigate current risks and reduce future risks associated 
with infusion pumps.

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

[[Page 21633]]

represent 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 draft guidance may do 
so by using the Internet. To receive ``Total Product Life Cycle: 
Infusion Pump--Premarket Notification [510(k)] Submissions,'' you may 
either send an e-mail 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 1694 to identify 
the guidance you are requesting. 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.

IV. Paperwork Reduction Act of 1995 (the PRA)

    Under the PRA (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. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: 
Infusion Pump--Premarket Notification [510(k)] Submissions

    This draft guidance is intended to assist industry in preparing 
premarket notification submissions for infusion pumps and to identify 
device features that manufactures should address throughout the total 
product life cycle. The premarket notification procedures discussed in 
the draft guidance (21 CFR 807, subpart E) have been approved under OMB 
control number 0910-0120. The proposed information collection seeks to 
add clinical or scientific data demonstrating that new or changed 
infusion pumps are as safe and effective as those legally marketed and 
do not raise different questions of safety and effectiveness than 
predicate devices in this generic device type. In this way 
manufacturers of infusion pumps may demonstrate substantial equivalence 
and receive premarket clearance for their devices.
    Description of Respondents: The respondents to this collection of 
information are infusion pump manufacturers subject to FDA's laws and 
regulations. The agency estimates the burden of this collection of 
information as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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     Guidance Title: Infusion Pumps--  Premarket                             Annual Frequency     Total Annual        Hours per
           Notification 510(k) Submissions             No. of  Respondents     per Response         Responses         Response           Total Hours
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Guidance Section 6--Assurance Case Report                               31                   1                31                56                 1,736
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.

    FDA estimates it will receive 31 infusion pump submissions 
annually. The agency reached this estimate by averaging the number of 
premarket notifications for infusion pumps submitted to FDA over the 
past 5 years. The draft guidance identifies 56 potential hazards FDA 
recommends addressing if applicable to a particular device. Although 
there may be additional hazards identified by a manufacturer, the 
agency believes these hazards may offset FDA identified hazards not 
applicable to a particular device. FDA estimates it will take infusion 
pump manufactures approximately 56 hours (approximately one hour per 
hazard) to complete the case assurance report described in section 6 of 
the draft guidance. FDA reached this estimate based on its expectation 
of the amount of information that will be contained in the report.
    Before the proposed information collection provisions contained in 
this draft guidance become effective, FDA will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the information collection provisions. An agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.
    This draft 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 814, subparts B and E are approved under OMB 
control number 0910-0231; 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; 
and the collections of information in 21 CFR 56.115 are approved under 
OMB control number 0910-0130.

[[Page 21634]]

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified 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: April 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9209 Filed 4-23-10; 8:45 am]
BILLING CODE 4160-01-S