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Planned US Device-Center Reorg Will Be Organized Around Device Types

 
• By Elizabeth Orr

CDRH compliance official Sean Boyd described agency plans to group staff in device-specific offices that would handle products from pre-market review through inspections and enforcement. If approved, the reorganization would go forward in 2018.

A planned reorganization of US FDA’s device center would see review staff organized by device type, rather than by stage in the device cycle. Its scheduled to get off the ground in 2018.

CDRH Director Jeff Shuren first announced plans for a new "super office" that would break down barriers between current review, compliance and surveillance offices in September. (Also see "'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover" - Medtech Insight, 29 September, 2017

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South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.