Today CDRH issued its regulatory science priorities for FY 2017. The goal is to boost device safety and effectiveness, performance and quality. The priorities are:
- Use big data for regulatory decision-making
- Modernize biocompatibility and biological risk evaluation of device materials\
- Leverage real-world evidence and use evidence synthesis across multiple domains in regulatory decision-making
- Advance tests and methods for predicting and monitoring clinical performance of medical devices
- 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
- Strengthen medical device cybersecurity
- Reduce healthcare-associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices
- Collect patient input for regulatory decision-making
- Leverage precision medicine and biomarkers for predicting device performance, disease diagnosis and progression
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