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Abstract #4198

Retrospective Analysis of Radio-frequency Safety of Orthopedic Passive Implantable Device

Kyoko Fujimoto1, An Smith1,2, Leonardo M Angelone1, Vikansha Dwivedi1, Sunder S Rajan1, Brent L Showalter1, and Nicole LL McMinn1
1Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, United States, 2University of Virginia, Charlottesville, VA, United States

Implantable medical devices marketed in the US may include MRI Safety Information, to allow patients with such devices to safely undergo MR scans. However, some implantable devices are not evaluated for MR compatibility due to constraints of the testing cost and other resources. Not having MRI Safety Information in labeling limits patients’ access to MR scans. This study aimed to perform a retrospective analysis of MR safety testing data included in previously cleared 510(k) submissions for implantable orthopedic devices, with the goal to generate datasets that may help establish guidelines that potentially reduce the regulatory burden for future pre-market submissions.

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