Q - Can you reconcile statements (at FFL) about AP and mortality with the deaths of adolescents due to nocturnal hypoglycemia our community has mourned this year. Specifically does the agency see that the lack of LGS guidance in the US market may have played a role in these cases of mortality that LGS may have prevented?
A - The FDA is acutely aware of the struggles of diabetics, especially in children, adolescents and their parents and makes every effort to encourage and enhance the development of breakthrough medical devices, including those that suspend basal insulin delivery when blood glucose levels are thought to be in or approaching low glucose concentrations. Although guidance documents are one way of doing that, it is often challenging to provide guidance on a topic which the FDA has not yet developed the expertise necessary to do this. Recognizing the importance of cooperative efforts, the FDA has an open-door policy, and in fact encourages all manufacturers to work with us as they develop and conduct studies to evaluate new devices. The pre-submission, also referred to as the pre-Investigational Device Exemption or pre-IDE process, allows manufacturers to present the FDA with their plans for developing their products and obtain guidance. This process is often more valuable than a generic guidance document as it is specific to the strengths and limitations of that manufacturer's product and can be developed to support the specific claims that are sought by that manufacturers for that device.