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[IP] The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems

ts/ucm259301.htm Draft Guidance for Industry and Food and Drug Administration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 I.
IntroductionThis draft guidance is intended to provide recommendations to
Sponsors or Applicants1 planning to develop and to submit, an Investigational
Devices Exemption (IDE) or marketing application for a Low Glucose Suspend
(LGS) system for single patient use in the home environment. The guidance
discusses critical elements regarding nonclinical testing and clinical studies
needed to support such an application. Section VII of the guidance and
Appendix A identify the necessary information for an IDE submission whereas
the rest of this guidance describes the information necessary to support a
premarket approval (PMA).FDA's guidance documents, including this guidance, do
not establish legally enforceable responsibilities. Instead, guidances
describe the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidances means that something is
suggested or recommended, but not required.II. BackgroundDiabetes mellitus has
reached epidemic proportions in the United States (US) 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.Today, patients with Type 1 Diabetes2,3 (T1D) utilize a variety of
devices to monitor and manage their blood glucose levels. Hand-held portable
glucose meters which have been cleared by FDA for home-use, referred to as
Self Monitoring Blood Glucose (SMBG) devices in this document, allow patients
to determine what their blood glucose level is by performing a finger stick.
Patients use SMBG devices multiple times a day to help make decisions
regarding insulin administration. Some patients also use insulin pumps that
allow for continuous subcutaneous insulin infusion (CSII). The most recent
device available to patients is the continuous glucose monitoring system
(CGM), which uses a sensor inserted into the subcutaneous tissue and
continuously measures the concentration of glucose in the interstitial fluid.
While not a substitute for testing glucose in the blood, the CGM device allows
patients to monitor trends and patterns of glucose excursions. However, even
with the aid of these devices, maintaining blood glucose levels within a
suggested optimal range is a daily struggle for people living with T1D, and
the risk of hypoglycemia associated with tight glycemic control remains an
ever-present danger to patients with diabetes.An LGS system links a CGM to an
insulin pump and automatically suspends or reduces insulin infusion
temporarily based upon specified thresholds of measured interstitial glucose
levels. An LGS system is a type of autonomous system commonly known as an
artificial pancreas. This type of system is designed to reduce the likelihood
and/or severity of a hypoglycemic event.
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