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...
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
