Regulatory Focus™ > News Articles > 2019 > 7 > First FDA-Developed Medical Device Development Tool Receives Qualification

Regulatory NewsRegulatory News
Posted 15 July 2019 | By Ana Mulero 

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 receive 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.
FDA issued final guidance in August 2017 on the MDDT program, which is intended to accelerate product development and increase consistency in regulatory submissions. The agency qualified the first MDDT—the 23-item Kansas City Cardiomyopathy Questionnaire —shortly thereafter. The 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 are clinical outcome assessment tools and the third is a biomarker test. The fourth—the TMM—falls under the category of nonclinical assessment.
FDA scientists at the Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering (OSEL) developed the TMM “after observing a trend of increasing premarket submissions using HITU for a variety of treatments,” OSEL Director Ed Margerrison and MDDT program Director Hilda Scharen wrote in a blog post last week. “FDA scientists focused on creating a standardized testing method for the developers who had been using their own individual formulations to develop phantoms or other methods of testing their devices.”
CDRH has discussed its vision for the MDDT program in recent months. It intends to leverage the program for cybersecurity and plans to qualify more tools based on different use cases.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found