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First Medical Device Development Tool by FDA Received Qualification

15th July 2019

The USFDA has developed the first medical device development tool (MDDT), which is a tissue mimicking material (TMM) used in the preclinical development and evaluation of ultrasound medical devices. The MDDT received the FDA qualification as well.

The device developers can test the safety of their high-intensity therapeutics ultrasounds (HITU) devices using this MDDT before moving to clinical trials. After receiving the TMM’s qualification, MDDT program now offers tools in each of its three categories.

In August 2017, the FDA issued final guidance on MDDT program, which intends to accelerate product development and increase consistency in regulatory submissions. Shortly after this, the agency qualified the first MDDT – the 23-item Kansas City Cardiomyopathy Questionnaire. Minnesota Living with Heart Failure Questionnaire and the OsiriX CDE Software Modul became the second and the third FDA-qualified MDDTs in May 2018 and in March, respectively. The first two MDDTs are used for clinical outcome assessment and the third one is a biomarker test. The fourth MDDT i.e. TMM falls under nonclinical assessment category.

Center for Devices and Radiological Health’s (CDRH) intends to take the program for cybersecurity and plans to qualify more tools based on different uses.

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