CDRH REGULATORY SCIENCE PRIORITIES (FY2017) for medical devices

In 2015, CDRH published its first set of regulatory science priorities. We have since refined and improved the process for generating our priorities and are issuing our FY 2017 regulatory science priorities.

The following are the current CDRH’s 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

·     Advance tests and methods for predicting and monitoring medical device clinical

performance

·     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 strengthen medical device cyber-

security

·     Reduce healthcare associated infections by better understanding the effective-

ness of antimicrobials, sterilization and reprocessing of medical devices

·     Collect and use patient input in regulatory decision-making

·     Leverage precision medicine and biomarkers for predicting medical device per-formance, disease diagnosis and progression