Novel treatments for traumatic brain injury on the horizon with the qualification of a medical device development tool
Yesterday the Food and Drug Administration qualified the OsiriX CDE Software Module, from the TBI Endpoints Development Initiative – the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a biomarker test tool type. A biomarker test is a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment (biomarker). This qualification provides a tool for more efficient development of devices in a critical area of medicine – traumatic brain injury (TBI) treatment.
The MDDT program enables the FDA to qualify tools that medical device developers can use in the development of medical devices and the evaluation of their safety and effectiveness. Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically and clinically meaningful measurements of data that can be used to help inform medical product development within the specified context of use. In this case, the OsiriX CDE, qualification means that the tool may be used to better identify eligible patients for enrollment in clinical trials.
The OsiriX CDE consists of a software module that assists healthcare providers, such as neuroradiologists, by providing a standardized way to mark and classify brain contusions using common criteria and to label abnormalities on magnetic resonance images for the purpose of enriching enrollment in clinical trials of therapeutic medical devices intended to improve outcomes of mild TBI patients. The FDA’s qualification of a medical device development tool is different from the FDA’s marketing authorization (clearance or approval) of a medical device. The type of evidence needed to support qualification of a MDDT is not the type of evidence that is needed to support marketing authorization for a medical device. Qualified MDDTs are not intended for clinical diagnosis or treatment of a patient outside of their specified context of use in the conduct of medical device development studies.
The FDA expects to continue to evaluate and qualify more MDDTs in the future, which the agency encourages through extensive interactions with product developers creating these tools. The development of efficient tools for measuring outcomes relevant to regulatory decisions is a key part of the agency’s efforts to make medical product development more efficient and promote innovation. Such development tools can help minimize the use of animal studies, reduce the duration of testing, or require fewer patients in a study by optimizing patient selection or improving the ability to measure benefit and risk through the availability of measurements that are more sensitive for assessing these outcomes.
