CDRH Qualifies 3rd Medical Device Development Tool

Regulatory NewsRegulatory News | 13 March 2019 |  By 

A software module intended to aid health care providers in marking and classifying brain contusions became the third medical device development tool (MDDT) to receive US Food and Drug Administration (FDA) qualification.

The Traumatic Brain Injury (TBI) Endpoints Development Initiative—supported by a 2014 Department of Defense grant worth $17 million over five years to identify and validate effective TBI endpoints in collaboration with FDA—received FDA qualification on Tuesday for its OsiriX CDE Software Module under the MDDT program run by FDA’s Center for Devices and Radiological Health (CDRH). This marked the first biomarker test to receive qualification.

The OsiriX CDE aims to standardize how health care providers, such as neuroradiologists, mark and classify brain contusions using common data element (CDE) criteria, as well as label abnormalities observed in magnetic resonance images. This can inform clinical trial enrollment for the development of a mild TBI device.

The new MDDT qualification is not only the first for a biomarker test, but also the first in the medical area of TBI. The first two—the Kansas City Cardiomyopathy Questionnaire and the Minnesota Living with Heart Failure Questionnaire —were qualified in 2017 and 2018, respectively, and both under the area of heart failure.  

The quick turnaround on the August 2018 submission for the TBI software module’s MDDT qualification underscores CDRH’s ongoing push for growing the MDDT program. This push seeks to “promote the creation and validation of biomarkers and tools that can provide more efficient and accurate ways to evaluate the safety and effectiveness of products,” FDA Commissioner Scott Gottlieb noted. With more MDDTs qualified based on different use cases, CDRH also intends to leverage the program to encourage cybersecurity by product design.


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