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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...

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• By Amanda Maxwell

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Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
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More from Policy & Regulation

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
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A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

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House Bill Calls For ‘Non-Flushable’ Label On Personal Wipes

 
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