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Entreprise · 29/06/20151 min de lecture
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance Environment for Multi-Configuration Passive Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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Résumé
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices." The purpose of this guidance is to provide an assessment paradigm for radiofrequency (RF)-induced heating on, or near, multi-component, or multi-configuration, passive medical devices in the magnetic resonance environment. This draft guidance is not final nor is it in effect at this time.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →