USA – First FDA-Developed Medical Device Development Tool Receives Qualification

A tissue mimicking material (TMM) for use in the preclinical development and evaluation of ultrasound medical devices became the first medical device development tool (MDDT) developed by the US Food and Drug Administration (FDA) to received FDA qualification.

Device developers can use this MDDT to help test the safety of their high-intensity therapeutics ultrasounds (HITU) devices before moving to clinical trials.

With the TMM’s qualification, the MDDT program now offers tools in each of its three categories.

FDissued final guidance in August 2017 on the MDDT program, which is intended to accelerate product development and increase consistency in regulatory submissions…