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Zdrowie i gospodarka · 22/05/1997

A Primer on Medical Device Interactions With Magnetic Resonance Imaging Systems; Draft Guidance; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems.'' The purpose of this document is twofold. It should serve to sensitize medical device reviewers to the meaning and ramifications of magnetic resonance (MR) safety or MR compatibility claims. It will also provide for FDA reviewers a background of MR theory and the effect the MR environment may have on medical devices.

Source: Federal Register — Food and Drug AdministrationOpen original release →