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About Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices


FDA’s Center for Devices and Radiological Health (CDRH) is responsible for assuring the safety, effectiveness, performance and quality of medical devices and radiation emitting products used to treat, prevent, and diagnose disease throughout the product life cycle thereby reducing the time to market, improving safety, and making the  process least burdensome.


CDRH has published FY 2017 regulatory science priorities to help focus the Center’s attention on the most important regulatory science gaps or needs as under :

  • 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 effectiveness 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 performance, disease diagnosis and progression

Document providing an overview of the process that CDRH used to generate these Priorities is available at :


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