The Food and Drug Administration's Center for Devices and Radiological Health released its list of regulatory science priorities for 2017.
Here are the 10 priorities the agency will focus on in the upcoming year, according to the report.
- Use "Big Data" for regulatory decision-making.
- Update biocompatibility and biological risk evaluation of device materials.
- Use real-world evidence and engage evidence synthesis across multiple domains in regulatory decision-making.
- Improve tests and methods for predicting and monitoring medical device clinical performance.
- Develop methods and tools to improve and streamline clinical trial design.
- Create computational modeling technologies to support regulatory decision-making.
- Enhance the performance of digital health and strengthen medical device cybersecurity.
- Better understand the effectiveness of antimicrobials, sterilization and reprocessing of medical devices to reduce healthcare-associated infections.
- Collect and consider patient input in regulatory decision-making.
- Rely on precision medicine and biomarkers for predicting medical device performance, disease diagnosis and progression.
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