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MEDICAL DEVICE LABELING ON MR COMPATIBILITY SHOULD CITE SPECIFIC TESTING ENVIRONMENT, FDA SAYS IN "PRIMER"; JUSTIFYING DATA FOR CLAIMS OUTLINED

This article was originally published in The Gray Sheet

Executive Summary

Medical devices should not be labeled as magnetic resonance "compatible" or "safe," FDA says in a draft "primer" on medical device interactions with MR imaging systems. Rather, labeling should describe the specific MR environment in which the device has been tested and deemed safe, the agency recommends in the draft document, which was recently released for comment.

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