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