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Magn Reson Imaging Clin N Am. 1998 Nov;6(4):791-5.

FDA regulation of the safety of MR devices: past, present, and future.

Magnetic resonance imaging clinics of North America

T W Athey

Affiliations

  1. C.L. McIntosh & Associates, Rockville, Maryland 20852, USA.

PMID: 9799856

Abstract

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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