FDA Ties Post-Approval Device Studies To Public Health

Law360, New York (August 20, 2012, 7:07 PM EDT) -- The U.S. Food and Drug Administration, which has struggled to improve its post-market surveillance of medical devices, said Monday that it would hold a workshop next week to discuss how to leverage post-approval studies, required for the riskiest devices, to improve public health.

At the workshop, the FDA plans to discuss getting more stakeholders, including public health groups and clinical researchers, to participate in the design of the studies and give them access to the study results. Giving the studies a public health angle could help...
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