FDAnews Device Daily Bulletin

FDA Reports to Congress on Regulatory Science Achievements

April 5, 2017

In a regulatory science update to Congress, the FDA cited its successes in helping to improve nonclinical evaluation of medical devices and develop new diagnostic tests for use during disease outbreaks.

CDRH researchers developed computational tools to support nonclinical evaluation of medical products, including mathematical representations of the human body that can be used to predict the effects of medical devices.

CDRH also supported the regulatory public health response to the Ebola and Zika viruses by helping to develop diagnostic tests and other tools, along with producing reference materials and science-based guidance.

The agency also cited the Centers of Excellence in Regulatory Science and Innovation — located at the University of Maryland, Georgetown University and the Johns Hopkins University — including joint efforts between the University of California at San Francisco and Stanford University, as well as between Yale University and the Mayo Clinic. The centers aim to address gaps in regulatory science.

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