FDA Qualifies MRI Compatibility and Safety Software as a New Medical Device Development Tool

The U.S. Food and Drug Administration (FDA) has qualified the IMAnalytics with MRIxViP1.5T/3.0T And BCLib extraction and evaluation tool through the Medical Device Development Tools (MDDT) program. This is the first computational modeling tool that can be used across a wide range of active implantable medical devices (AIMDs) and manufacturers qualified through the MDDT program.

The IMAnalytics with MRIxViP1.5T/3.0T and BCLib is a method for manufacturers to evaluate safety and compatibility of AIMDs active implanted medical devices in common magnetic resonance imaging (MRI) environments. Medical device sponsors interested in using this tool in device development should review the MDDT Qualification Summary for this tool, which presents a summary of the scientific evidence that served as the basis of the qualification decision.

Read the IMAnalytics Summary

Benefits of Tool Qualification

The FDA’s qualification of a medical device development tool is different from the FDA marketing authorization (clearance or approval) of a medical device. Qualified MDDTs are not intended for clinical diagnosis or treatment of a patient outside of medical device development studies.

Having a qualified tool means that product evaluation can be done more predictably and efficiently by providing innovators with the tools and techniques that the FDA has found to be acceptable for their purposes. This can eliminate much of the risk and uncertainty developers often experience in product development. The use of a qualified tool also allows FDA regulators to concentrate on the most important aspects of the process and ensure that the end products are developed in a safe and timely manner.