The FDA’s Center for Devices and Radiological Health (CDRH) released its latest top 10 regulatory science priorities yesterday.
They are:
- Use Big Data to aid in regulatory decision-making.
- Modernize biocompatibility and biological risk evaluation of device materials.
- Use real-world evidence and 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.
- Improve 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.
- Use precision medicine and biomarkers to predict medical device performance, disease diagnosis and progression.
The CDRH goals mirror some of those put forth this week by three former FDA commissioners, who emphasized using real-world data in several ways to improve the agency’s regulatory activities. The CDRH document also shared the goal of incorporating using patient input in regulatory decision-making.
This year’s list also closely mirrors the goals that CDRH set for fiscal year 2017. “Very little changed to
the overarching categories/themes of the priorities, and many of the priorities aligned with the Center’s 2018-2020 strategic plan,” the report said. “Therefore, the decision was made to retain the previous categories and focus on revising the priority descriptions.”
The agency said setting priorities helps focus its attention on the most important regulatory science gaps or needs. The priorities should also help improve medtech safety, effectiveness, performance and quality, ease the introduction of innovative medical devices, and guide CDRH’s decisions on research funding.
