FDA Revised Guidance on MR Safety: Hazards Explained
The article highlights the aspects related to various hazards associated with the use of medical devices magnetic resonance environment.
The article highlights the aspects related to various hazards associated with the use of medical devices magnetic resonance environment.
The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.
The article provides a general overview of the existing regulatory framework associated with adverse events.
The article describes in detail the approach to be applied with respect to clinical performance testing considerations including, inter alia, the ones associated with treatment parameters and protocols, safety and effectiveness endpoints and data, as well as adverse events
The new article highlights the aspects related to non-clinical testing considerations related to the devices covered by the scope of the guidance.