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Lifting The Hood On MDUFA V

 
• By Elizabeth Orr

The document includes promises from the US FDA related to review timelines, consensus standards, the Total Product Life Cycle pilot, and more.

• Source: Myron Standret / Alamy Stock Photo

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.

The latest draft agreement, which covers fiscal years 2023-2027, was released for public review on 23 March. It goes beyond approval timelines to include FDA promises related to infrastructure,...

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