FDA regulation of the safety of MR devices: past, present, and future.
The history of the Food and Drug Administration's (FDA) regulation of safety issues for MR devices is reviewed in this article. The guidance documents and policies that FDA has used from 1982 to the present to ensure safety are summarized. The present status of FDA regulatory policies and apparent plans for the future are included.
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C.L. McIntosh & Associates, Rockville, Maryland 20852, USA.
D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects / Q000592:standards*; D012449:Safety / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration