Big Data, Real-World Evidence Are Top Device Center Reg Science Priorities

Utilizing big data and real-world evidence to assist in regulatory decision-making is a top priority of FDA's medical device center, according to a report published Tuesday (Sept. 20). FDA's Center for Devices and Radiological Health laid out its 10 regulatory science priorities for fiscal year 2017 , updating a list of priorities published in 2015. Leveraging "big data warehouses" in order to help detect emerging post-market issues, and modernizing biocompatibility and biological risk evaluation to help assess the risk of...