Using FDA-Qualified MDDTs to Accelerate Medical Device Development

When:

Wednesday, June 15 | 1:20 pm - 1:35 pm

Where:

Booth 636 - MED Institute

Level:

All Levels

Participant Type:

Product Development, Quality/Regulatory


The FDA MDDT program supports innovation in medical device development and regulatory science, helping to bridge the gap between the research of medical devices and the delivery of devices to patients. The program provides FDA with qualified tools that medical device sponsors can utilize during the evaluation and development of medical devices. To earn qualification, FDA evaluates the submitted tool and reviews available supporting evidence to determine whether the tool can provide scientifically plausible measurements. MED Institute obtained FDA qualification of their MDDT (Medical Device Development Tool) for virtual MRI safety evaluations, to determine if MRI imaging is safe for patients with implanted medical devices. MED Institute’s MDDT utilizes computational modeling and simulation to predict RF-induced heating of passive orthopedic devices during MRI, for both 1.5 T and 3 T, with higher quality and reliability and at a lower cost than physical testing.

Speaker: David Gross, Director, MRI Safety Evaluations, MED Institute