From: Mondaq
Article by Edgar Asebey, Maureen Bennett, Cristiana Spontoni, Colleen Heisey, Christian Fulda, Chiang Ling Li, Katherine M. Llewellyn, Stephanie L. Resnik, Matthew R. Bowles, Mitsutaka Okano and Katherine S. Makielski | Jones Day
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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