FDA Qualifies First Biomarker Test as Part of MDDT Program

The U.S. Food and Drug Administration (FDA) has qualified the OsiriX CDE Software Module through the Medical Device Development Tools (MDDT) program. The OsiriX CDE Software Module is the first biomarker test qualified through the Medical Device Development Tools program. 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). The OsiriX CDE Software Module was submitted by the TBI Endpoints Development (TED) Initiative.

The OsiriX CDE consists of a software module that assists expert readers of Magnetic Resonance (MR) images.
The tool provides a standardized way to mark boundaries and classify brain contusions (bruises) using Common Data Element (CDE) criteria.
This information can be used to label abnormalities on MR images for the purpose of enriching enrollment in clinical trials for therapeutic medical devices intended to improve outcomes of mild Traumatic Brain Injury (TBI) patients.
Qualification of this tool means it can be used by medical device developers to identify and enroll patients into TBI studies.

Impact of Tool Qualification

The MDDT program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices. Qualification means that the agency has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically and clinically meaningful measurements within the authorized context of use. Qualified tools serve as a resource that can be referenced by any medical device sponsor.

When used consistent with the qualified Context of Use,

the results of an assessment that uses an MDDT can be relied upon in device evaluation and to support regulatory decision-making;
the qualification eliminates burden on the sponsor to demonstrate tool validation; and
it reduces the advisory time for the FDA staff by eliminating need to evaluating the validity and suitability of the tool in device evaluation.

Medical device sponsors interested in potentially using this tool in device development and evaluation should begin by reviewing the MDDT Qualification Summary for this tool.

FDA qualification of a medical device development tool is different from FDA marketing authorization (clearance or approval) of a medical device. Qualified MDDTs are not intended for clinical diagnosis or treatment of a patient outside of medical device development studies.

Read More Here