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Regulatory News | 21 September 2016 | By Zachary Brennan
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) plans to leverage real-world evidence and more “Big Data” for regulatory decisions, according to a list of its science priorities for 2017.
As far as what will change between 2016 and 2017, the 13-page report says that thanks to more “needs submissions from staff,” CDRH was able to identify new topic areas, including clinical trial design and precision medicine, as well as describe existing topic areas in greater detail.
“Although the area of human factors is not prominently identified as a priority, it is still an unmet need and is reflected in the descriptions of other FY 2017 top ten priorities (e.g. infection control and predicting medical device clinical performance). Patient reported outcome measures and patient preference were combined as patient input and the reprocessing priority was renamed to the more inclusive topic of infection control,” the report says.
The top ten CDRH regulatory science priorities include:
Tags: CDRH, device priorities, real-world data for devices