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Speaking Of Medtech, Ep. 5: MDUFA V User-Fee Negotiations

 
• By Steve Silverman and Shawn M. Schmitt

In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down.

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More from Regulation

EU Harmonized Standards Continue To Trickle In Under MDR

 
• By Amanda Maxwell

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

Commission Needs To Prioritize Devices Agency Above All Else

 
• By Amanda Maxwell

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.

Draft FDA Reorganization Would Unite All Product Centers

 
• By Sarah Karlin-Smith

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

End Of The Road? Court LDT Decision May Leave FDA With Few Options

 
• By Brian Bossetta

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?

More from Policy & Regulation

IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

 
• By Elizabeth Orr

International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.

CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 
• By Natasha Barrow

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.

Commission Needs To Prioritize Devices Agency Above All Else

 
• By Amanda Maxwell

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.