On October 20, 2015, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released its top ten Regulatory Science Priorities for FY 2016 to facilitate improvements in the safety and effectiveness of medical devices and accelerate innovation. Several of the priorities would harness health information technology or health data to improve regulatory decision making, such as by:
- Leveraging “Big Data” warehouses such as the human genome sequence database and clinical trials databases. CDRH notes that these sources are “underutilized in regulatory decision making” and could “streamlin[e] scientific review and identif[y] potential emergency post-market issues earlier in the process.”
- Researching ways to improve device cybersecurity and enhance the performance of devices, including through interoperability and an understanding of how software modifications impact device performance.
- Leveraging evidence from clinical experience, such as after-marketing observational data in healthcare databases.
- Developing and validating instruments for collecting and using patient experience data and patient reported outcome measures (PROMs).
Other identified priorities include: developing a comprehensive approach to reprocessing reusable medical devices, including to minimize infection transmission and monitor outcomes; developing computational modeling techniques to support regulatory decision making; utilizing human factors engineering principles to assess device design and usability; better assessing and predicting the biological risk factors of devices; and better predicting the clinical performance of devices and assessing the impact of new materials and technologies.
CDRH envisions using these priorities to make strategic intramural funding decisions that support regulatory science goals and ultimately support public health and/or regulatory decision-making. The Center also hopes that external stakeholders can rely on the priorities to target their own resources.