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Medcon

Rise In Class I Device Recalls A ‘Grave Concern,’ Says FDA’s Anne Reid

Rise In Class I Device Recalls A ‘Grave Concern,’ Says FDA’s Anne Reid

 
• By Brian Bossetta

The number of class I medical device recalls has increased over the last decade, and that concerns officials at the FDA.

Shuren Says CDRH Is ‘Turning The Ship Around’ As Operations Return To Normal

Shuren Says CDRH Is ‘Turning The Ship Around’ As Operations Return To Normal

 
• By Brian Bossetta

The director of the US FDA’s device center discussed several of the center’s priorities at Medcon, such as moving beyond the pandemic, focusing on patients, and advancing health equity.

Medcon 2023: FDA Hopes To Release Final QMSR By Year’s End

Medcon 2023: FDA Hopes To Release Final QMSR By Year’s End

 
• By Elizabeth Orr

The destination may be in sight for the long trip that’s been the US agency’s quality systems rewrite. Regulators speaking at Medcon 2023 said December remains the goal for publication.

Medcon 2023: Shuren Mulls New Pathway For Digital Devices

Medcon 2023: Shuren Mulls New Pathway For Digital Devices

 
• By Elizabeth Orr

The head of the US FDA’s Center for Devices and Radiological Health said that an optional new pathway could help the agency regulate the flood of novel devices intended for at-home use. His presentation also touched on MDUFA V implementation, post-pandemic strategy, and CDRH staffing needs.