Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption and Premarket Approval Applications for Low Glucose Suspend Device Systems; Availability, 36542-36543 [2011-15541]
Download as PDF
<![CDATA[
36542
Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: June 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–15592 Filed 6–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0464]
Draft Guidance for Industry and Food
and Drug Administration Staff: The
Content of Investigational Device
Exemption and Premarket Approval
Applications for Low Glucose Suspend
Device Systems; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
document entitled ‘‘Draft Guidance for
Industry and Food and Drug
Administration Staff: The Content of
Investigational Device Exemption (IDE)
and Premarket Approval (PMA)
Applications for Low Glucose Suspend
(LGS) Device Systems.’’ This draft
guidance document provides industry
and Agency staff with recommendations
that are intended to improve the safety
and effectiveness of LGS Device
Systems. This draft guidance is not final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considers your comment on this draft
guidance before it begins work on the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on the draft guidance by September 20,
2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Draft Guidance for
Industry and Food and Drug
Administration Staff: The Content of
Investigational Device Exemption (IDE)
and Premarket Approval (PMA)
Applications for Low Glucose Suspend
(LGS) Device Systems’’ 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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:40 Jun 21, 2011
Jkt 223001
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 https://
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:
Charles Zimliki, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 2556, Silver Spring,
MD 20993–0002, 301–796–6297.
SUPPLEMENTARY INFORMATION:
I. Background
Diabetes mellitus has reached
epidemic proportions in the United
States and more recently, worldwide.
The morbidity and mortality associated
with diabetes is anticipated to account
for a substantial proportion of health
care expenditures. Although there are
many devices available that help
patients manage the disease, FDA
recognizes the need for new and
improved devices for treatment of
diabetes. One of the more advanced
diabetes management systems is an
artificial pancreas device system. An
artificial pancreas system is a type of
autonomous system that adjusts insulin
infusion based upon the continuous
glucose monitor via control algorithm.
There are a variety of types of artificial
pancreas systems depending upon the
nature of the control algorithm. They
can be generally divided into three
categories, LGS, Treat-to-Range, and
Treat-to-Target. In this notice, FDA is
announcing a draft guidance for the first
type of artificial pancreas, the LGS
system. An LGS system links a
continuous glucose monitor to an
insulin pump and automatically reduces
or suspends insulin infusion
temporarily based upon specified
thresholds of measured glucose levels.
This type of system is designed to
reduce or mitigate the likelihood of a
hypoglycemic event. There are
significant challenges in creating an
autonomous system, which were
discussed in a joint FDA and National
Institutes of Health (NIH) artificial
pancreas workshop on November 10,
2010 (information available at: https://
www.fda.gov/MedicalDevices/News
Events/WorkshopsConferences/
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
ucm226251.htm. Currently, there is no
FDA-approved artificial pancreas for
home use. This workshop sought
feedback on ways to overcome the
obstacles towards developing an
artificial pancreas. The feedback
received from this workshop and the
continued communication with
investigators in this field has provided
valuable input for FDA’s first guidance
for a LGS device. This guidance will
outline considerations for development
of clinical studies, and recommends
elements that should be included in IDE
and PMA applications, focusing on
critical elements of safety and
effectiveness for approval of this device
type. The guidance includes one
suggested approach to support safety
and effectiveness, but given the early
stage of this technology, FDA is open to
considering alternative study design
approaches and seeks comments
regarding alternative approaches. FDA
particularly seeks comments regarding
the validity of the Continuous Glucose
Monitor based event for hypoglycemia
endpoint, pivotal study design, and
patient population. As the LGS system
is one of three types of artificial
pancreas systems, comments to the LGS
guidance will not only assist FDA in
finalizing guidance on LGS systems, but
also assist in developing future draft
guidance for the other types of artificial
pancreas systems. FDA continues to
work with the investigators in this field
and is developing a second guidance to
address the remaining artificial pancreas
device systems.
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 LGS Device systems. 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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Draft Guidance for Industry
and Food and Drug Administration
Staff: The Content of Investigational
Device Exemption (IDE) and Premarket
E:\FR\FM\22JNN1.SGM
22JNN1
Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices
Approval (PMA) Applications for Low
Glucose Suspend (LGS) Device
Systems,’’ you may either send an email request to dsmica@fda.hhs.gov 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 1748 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 and guidance
documents. 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
parts 801 and 809 are currently
approved under OMB control number
0910–0485, the collections of
information in 21 CFR part 812 are
currently approved under OMB control
number 0910–0078, and the collections
of information in 21 CFR part 814 are
currently approved under OMB control
number 0910–0231.
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. It is no longer necessary to
send two copies of mailed 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: June 16, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–15541 Filed 6–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2011–D–0469]
Draft Guidance for Industry and Food
and Drug Administration Staff:
Applying Human Factors and Usability
Engineering To Optimize Medical
Device Design; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
16:40 Jun 21, 2011
Jkt 223001
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
document entitled ‘‘Draft Guidance for
Industry and Food and Drug
Administration Staff: Applying Human
Factors and Usability Engineering to
Optimize Medical Device Design.’’ The
recommendations in this guidance are
intended to improve the safety and
effectiveness of devices and reduce use
error. 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
§ 10.115(g)(5) (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 electronic or written
comments on the draft guidance by
September 19, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Draft Guidance for
Industry and Food and Drug
Administration Staff: Applying Human
Factors and Usability Engineering to
Optimize Medical Device Design’’ 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 https://
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:
Molly Story, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 2533, Silver Spring,
MD 20993–0002, 301–796–1456, e-mail:
molly.story@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
To understand use-related hazards, it
is necessary to have an accurate and
complete understanding of how a device
will be used. Understanding and
optimizing how people interact with
technology is the subject of human
factors engineering (HFE) and usability
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
36543
engineering (UE). HFE/UE
considerations that are important to the
development of medical devices include
three major components of the deviceuser system: (1) Device users, (2) device
use environments, and (3) device user
interfaces.
For safety-critical technologies such
as medical devices, the process of
eliminating or reducing design-related
use problems that contribute to or cause
unsafe or ineffective medical treatment
is part of a process for controlling
overall risk. For devices where harm
could result from ‘‘use errors,’’ the
dynamics of user interaction are safetyrelated and should be components of
risk analysis and risk management. By
incorporating these considerations into
the device development process,
manufacturers can reduce the overall
risk level posed by their devices, thus
decreasing adverse events associated
with the device, and avoid potential
device recalls.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This draft guidance, when finalized,
will represent the Agency’s current
thinking on human factors engineering
for medical devices. 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 is
available for all CDRH guidance
documents at https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
default.htm. Guidance documents are
also available at https://
www.regulations.gov. To receive ‘‘Draft
Guidance for Industry and Food and
Drug Administration Staff: Applying
Human Factors and Usability
Engineering to Optimize Medical Device
Design.’’ you may either send an e-mail
request to dsmica@fda.hhs.gov 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 1757 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
E:\FR\FM\22JNN1.SGM
22JNN1
]]>Agencies
[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36542-36543]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15541]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0464]
Draft Guidance for Industry and Food and Drug Administration
Staff: The Content of Investigational Device Exemption and Premarket
Approval Applications for Low Glucose Suspend Device Systems;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance document entitled ``Draft Guidance
for Industry and Food and Drug Administration Staff: The Content of
Investigational Device Exemption (IDE) and Premarket Approval (PMA)
Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft
guidance document provides industry and Agency staff with
recommendations that are intended to improve the safety and
effectiveness of LGS Device Systems. 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 September 20, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and Food and
Drug Administration Staff: The Content of Investigational Device
Exemption (IDE) and Premarket Approval (PMA) Applications for Low
Glucose Suspend (LGS) Device Systems'' 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 https://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: Charles Zimliki, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 2556, Silver Spring, MD 20993-0002, 301-
796-6297.
SUPPLEMENTARY INFORMATION:
I. Background
Diabetes mellitus has reached epidemic proportions in the United
States and more recently, worldwide. The morbidity and mortality
associated with diabetes is anticipated to account for a substantial
proportion of health care expenditures. Although there are many devices
available that help patients manage the disease, FDA recognizes the
need for new and improved devices for treatment of diabetes. One of the
more advanced diabetes management systems is an artificial pancreas
device system. An artificial pancreas system is a type of autonomous
system that adjusts insulin infusion based upon the continuous glucose
monitor via control algorithm. There are a variety of types of
artificial pancreas systems depending upon the nature of the control
algorithm. They can be generally divided into three categories, LGS,
Treat-to-Range, and Treat-to-Target. In this notice, FDA is announcing
a draft guidance for the first type of artificial pancreas, the LGS
system. An LGS system links a continuous glucose monitor to an insulin
pump and automatically reduces or suspends insulin infusion temporarily
based upon specified thresholds of measured glucose levels. This type
of system is designed to reduce or mitigate the likelihood of a
hypoglycemic event. There are significant challenges in creating an
autonomous system, which were discussed in a joint FDA and National
Institutes of Health (NIH) artificial pancreas workshop on November 10,
2010 (information available at: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm226251.htm. Currently, there is no
FDA-approved artificial pancreas for home use. This workshop sought
feedback on ways to overcome the obstacles towards developing an
artificial pancreas. The feedback received from this workshop and the
continued communication with investigators in this field has provided
valuable input for FDA's first guidance for a LGS device. This guidance
will outline considerations for development of clinical studies, and
recommends elements that should be included in IDE and PMA
applications, focusing on critical elements of safety and effectiveness
for approval of this device type. The guidance includes one suggested
approach to support safety and effectiveness, but given the early stage
of this technology, FDA is open to considering alternative study design
approaches and seeks comments regarding alternative approaches. FDA
particularly seeks comments regarding the validity of the Continuous
Glucose Monitor based event for hypoglycemia endpoint, pivotal study
design, and patient population. As the LGS system is one of three types
of artificial pancreas systems, comments to the LGS guidance will not
only assist FDA in finalizing guidance on LGS systems, but also assist
in developing future draft guidance for the other types of artificial
pancreas systems. FDA continues to work with the investigators in this
field and is developing a second guidance to address the remaining
artificial pancreas device systems.
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 LGS Device
systems. 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. To receive
``Draft Guidance for Industry and Food and Drug Administration Staff:
The Content of Investigational Device Exemption (IDE) and Premarket
[[Page 36543]]
Approval (PMA) Applications for Low Glucose Suspend (LGS) Device
Systems,'' you may either send an e-mail request to dsmica@fda.hhs.gov
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
1748 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 and guidance documents. 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 parts
801 and 809 are currently approved under OMB control number 0910-0485,
the collections of information in 21 CFR part 812 are currently
approved under OMB control number 0910-0078, and the collections of
information in 21 CFR part 814 are currently approved under OMB control
number 0910-0231.
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. It is no
longer necessary to send two copies of mailed 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: June 16, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-15541 Filed 6-21-11; 8:45 am]
BILLING CODE 4160-01-P
