Regulatory Open Forum

  • 1.  RE:MR Compatibility

    Posted 15-Apr-2014 12:40
    Paul,

    1.5 Telsa - currently the most common
    3 Telsa - becoming popular

    Putting "MR-conditional" constitutes or should be interpreted to constitute a significant change to the labeling.  Thus, it would require a new 510(k) submission.  

    As for testing to claim "MR-conditional," please refer to FDA Guidance.

    Standards to refer to include ASTM F2052, F2119, F2182, and F2213

    FDA recommends "Accurate assessment of the whole body averaged specific absorption rate (WB-SAR) used in your testing is critical to determining whether your testing represents reasonable worst-case heating conditions. Therefore, we recommend that you base WB-SAR assessments upon calorimetry measurements rather than relying on the MR scanner display, which may not have adequate accuracy."

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