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BioWorld - Sunday, July 26, 2026
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Home » FDA final guidance for MR labeling and testing offers tweaks to 2019 draft
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FDA final guidance for MR labeling and testing offers tweaks to 2019 draft

May 24, 2021
By Mark McCarty
The impact of MRI procedures on medical devices has been the subject of regulatory concern for better than a decade, but the FDA needed until 2019 to craft a guidance that deals with testing and labeling for such considerations. The final guidance offers several tweaks and adjustments to the 2019 draft, but ignores several requests made by industry, including a request that the final not rely on a clinically relevant worst-case scenario when evaluating the potential for device heating.
Medical technology Regulatory Medical devices U.S. FDA

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