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FDA Draft Guidance

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

Our multi-disciplinary team has extensive experience in medical device simulation and testing, including but not limited to MRI safety evaluations of medical devices. Since 2014, we have been involved in a Research Collaboration Agreement (RCA) with the FDA on the topic of radiofrequency safety assessments of passive implants using computational modeling and simulation (CM&S) of devices in phantoms and virtual human anatomies.

Last August the FDA published this draft guidance to promote consistency of reviews, testing, and MRI safety labeling across medical devices. In response to the draft guidance we submitted our comments along with assisting with comments from our parent company, Cook Group, due to our relevant experience with medical device simulation and performing MRI safety evaluations of numerous types of medical devices.

Our comments to FDA were intended to convey our support of the new guidance document in its efforts to address limitations of the existing FDA guidance related to MRI safety of medical devices and to provide feedback through constructive comments. We did this in an attempt to represent the safety labeling needs of medical device manufacturers and to highlight the public health advantages offered by modeling and simulation. While we recognize the importance of physical testing in the development of standards, we would like to stress that the capabilities of computational modeling and simulation (CM&S) go beyond the restrictions of testing with MRI scanners. Our CM&S capabilities have lowered the cost and time of MRI safety evaluations, and have improved their quality and reliability. Device manufacturers and patients benefit from the practicality and improved accuracy that computer simulation provides. Therefore, we recommend a greater emphasis be placed on CM&S throughout the draft guidance.

Are you interested in submitting your own comments to future FDA draft guidances? Learn more here!

For more information about how we can partner with you, please visit medinstitute.com or contact us at 855.463.1633.