CDRH Outlines Regulatory Priorities for Fiscal 2017
The Center for Devices and Radiological Health released its top 10 list of regulatory priorities for fiscal year 2017.
The list adds some new topic areas, including clinical trial design and precision medicine, and it fleshes out existing areas, such as patient-reported outcome measures and reprocessing of devices.
The top 10 list is as follows:
- 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 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.