CDRH regulatory science priorities :

  • Leverage “Big Data” for regulatory decision-making .
  • Modernize biocompatibility and biological risk evaluation of device materials
  • Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making
  • Develop methods and tools to improve and streamline clinical trial design
  • Develop computational modeling technologies to support regulatory decision-making
  • Enhance the performance of Digital Health and medical device cybersecurity
  • Reduce healthcare associated infections by better understanding
  • Collect and use patient input in regulatory decision-making