On October 20, 2015, FDA's Center for Devices and
Radiological Health ("CDRH") issued a report on Regulatory Science Priorities (FY2016). The
report summarizes CDRH's top 10 regulatory science needs for
the coming year, which include: leveraging "big data" for
regulatory processes, improving the quality and effectiveness of
reprocessing reusable medical devices, enhancing the performance of
digital health and medical device cybersecurity, and collecting and
using patient experiences and preferences in regulatory decisions.
According to the document, regulatory science facilitates
CDRH's decision-making by developing well-founded analytical
tools and methodologies that reflect the perspectives of multiple
disciplines and enable data-driven decisions.
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