FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
BfArM
The new article provides an overview of the general requirements to be followed when filing submissions associated with digital health applications.
EU MDR/IVDR
The article provides an overview of the new regulation and highlights the key points associated thereto.
ANMAT
The article provides an overview of the new regulation and highlights the key points associated thereto.
FDA
The new article highlights the aspects related to design considerations including control mechanisms to be implemented. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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