FDA Qualifies 1st Biomarker Test Tool Type

FDA has qualified the OsiriX CDE software module from the TBI Endpoints Development Initiative as the first biomarker test tool type to be qualified. The agency says it is the third medical device development tool (MDDT) it has qualified.

The qualification is said to provide a tool for more efficient development of devices to treat traumatic brain injury. The MDDT program enables the agency to qualify tools that medical device developers can use in developing medical devices and evaluating their safety and effectiveness. “Qualification” means that 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. Qualification is different from marketing authorization, FDA says.