March 12, 2019
“We’re committed to providing tools and policies to enable the efficient development of novel technologies that can address significant unmet patient needs. This is especially true when it comes to the development of treatments for traumatic brain injury, where few treatment options exist,” said FDA Commissioner Scott Gottlieb, M.D. “Today’s qualification of the first biomarker test for brain injury may help innovators more efficiently enroll patients in clinical trials of therapeutic medical devices intended to be used to treat mild traumatic brain injury. A strategic goal of the FDA is to promote the creation and validation of biomarkers and development tools that can provide more efficient and accurate ways to evaluate the safety and effectiveness of products. Qualification of this tool demonstrates how the medical device development tools program advances the agency’s mission by modernizing regulatory approaches, reducing the time and resources needed to develop and assess new medical products, and ultimately accelerating patient access to safe, effective and innovative medical devices.”
Today, the U.S. Food and Drug Administration qualified the OsiriX CDE Software Module, from the TBI Endpoints Development Initiative. This is 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 health care 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.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.