EDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
FDA
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
FDA
The new article highlights the aspects related to non-clinical testing considerations related to the devices covered by the scope of the guidance.
MHRA
The article provides an overview of the new regulatory framework introduced in the United Kingdom as a pilot project.
