The Center for Devices and Radiological Health (CDRH), branch of the U.S. Food and Drug Administration (FDA), has issued its regulatory science priorities for FY2017.
According to the FDA, the priorities serve as a catalyst to improving the safety, effectiveness, performance and quality of medical devices and radiation-emitting products and to facilitate introducing innovative medical devices into the marketplace. These help focus the center’s attention on the most important regulatory science gaps or needs. The priorities are reassessed and updated periodically to reflect current regulatory science needs.
- 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 cybersecurity
- 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
The FDA envisions that, collaboratively with its external stakeholders, the CDRH can work to maximize the impact of regulatory science research investments which will lead to patients having faster access to more innovative, safer devices with reduced healthcare costs.