The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday.
The release of the list coincides with the overarching goal of CDRH regulatory science, which is to help develop and apply tools, standards and methodologies to study the safety, effectiveness, performance and quality of devices.
While serving as a way to help CDRH make strategic research funding decisions to ensure that the division's research is focused on the issues, gaps and needs relevant to the regulatory science of medical devices and radiation-emitting products, the list includes:
- Leveraging “Big Data” for regulatory decision making
- Using evidence from clinical experience and employing evidence synthesis
- Improving the quality and effectiveness of reprocessing reusable medical devices
- Developing computational modeling technologies to support regulatory decision making
- Enhancing the performance of digital health and medical device cybersecurity
- Incorporating human factors engineering principles into device design
- Modernizing biocompatibility and biological risk evaluation of device materials
- Advancing methods to predict clinical performance of medical devices and their materials
- Advancing the use of patient reported outcome measures in regulatory decision making
- Collecting and using patient experiences and preferences in regulatory decision making
Safety has always been a top priority for CDRH, though the report notes that there is "a gap in the availability of tools and methodologies to assess the impact of various materials and material types on the quality, performance and safety of medical devices, particularly when trying to predict long-term clinical outcomes."
Among other things, CDRH will look to new methodologies and tools that more accurately predict the clinical impact of surface coatings, materials corrosion and additive manufacturing on device quality, performance and safety. In addition, CDRH will promote the development of alternative materials and look to increase the safety of the design of devices.
The center also calls for more research to understand how to enhance the performance and security of medical devices, and to understand the impact of software modifications on device performance.
How the List Was Created
The Regulatory Science Subcommittee (RSS) of the CDRH Center Science Council, which was created in 2013, developed the priorities and needs assessments based on collections made by the RSS across all CDRH offices.
CDRH explains that the list was created to help assess the needs and gaps in regulatory science and that it's intended to be proactive and anticipatory, while being responsive to emerging public health issues.
CDRH Regulatory Science Priorities Report