FDA
The article highlights the key points related to the specific aspects to be considered when using real-world data to support marketing applications related to medical devices.
BfArM
The new article highlights the key points related to the studies to be carried out to demonstrate a positive supply effect.
FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
ANMAT
The article provides an overview of the new regulation and highlights the key points associated thereto.
