CDRH Unveils Top Regulatory Science Priorities for 2016

(FDA) Center for Food and Drug Administration for Devices and Radiological Health (CDRH) try to better exploit big data and advance the use of the results reported by patients in making regulatory decisions, according to a list 10 Regulatory scientific priorities on Tuesday.
The release of the list coincides with the primary objective of CDRH regulatory science, which is to help develop and implement tools, standards and methodologies to study the safety, efficiency, performance and quality of devices

Top 10

While serving as a way to help CDRH make strategic decisions on the funding of research to ensure that research in the division focuses on the challenges, gaps and regulatory requirements relevant to science and radiation-emitting products medical devices, The list includes:

•  Leverage "Big Data" for making regulatory decisions
•  Using evidence from clinical experience and the use of evidence synthesis
•  Improve the quality and efficiency of reprocessing reusable medical devices
•  development of computational modeling technologies to support regulatory decision making
•  Improve the performance of the digital health and medical device cyber security
•  integration of human factors engineering principles in the design of the device
•  Modernization and bio compatibility evaluation of bio hazard materials Devices
•  Promote methods to predict clinical performance materials and medical devices
•  Promote the use of outcome measures reported in patients taking regulatory decisions
•  Preparation and use of the experience and preferences of the patient regulatory decisions

Security

Security has always been a priority for CDRH, while the report notes that there is "a gap in the availability of tools and methodologies to assess the impact of different types of materials and the quality of materials, performance, and security devices doctors, especially when trying to predict long-term clinical results. "
Among other things, CDRH test new methodologies and tools that more accurately predict the clinical impact of surface coatings, corrosion of materials and additive manufacturing in the quality of equipment, performance and safety. In addition, CDRH promote the development of substitute materials and try to increase the safety of the design of the devices.
The center also requires more research to understand how to improve the performance and safety of medical devices, and understand the impact of software changes in device performance.