The Medical Device User Fee Amendments (MDUFA) provide industry with a once-every-five-years opportunity to hold the US Food and Drug Administration accountable for its performance in helping safe, effective devices reach the domestic market quickly. On the flip side, it allows the agency to get the crucial funds from industry that allow it to invest in performance-enhancing measures. For those reasons, regulators and device makers alike are eager to ensure their priorities are addressed in each agreement.
Lifting The Hood On MDUFA V
The document includes promises from the US FDA related to review timelines, consensus standards, the Total Product Life Cycle pilot, and more.
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