CDRH Gets New Postmarket Czar
CDRH has appointed Jonathan Sackner-Bernstein, MD as associate CDRH director for postmarket operations, CDRH Director Daniel Schultz told those at the Regulatory Affairs Professionals Society annual conference this week. He will oversee the center's Postmarket Transformation Initiative and head the "CDRH Matrix." The latter is a group of 13 cross-cultural teams, made up of people from different parts of the center who specialize in the same product areas. It was created to better enable dialogue about adverse events and other postmarket issues among center employees who oversee different regulatory stages of the same products. And that could mean that safety problems get identified and addressed more quickly. Sackner-Bernstein is a cardiologist who had served on the faculty at Columbia University and as chief medical officer of a contract research organization, Clinilabs. For CDRH, he had served on the Medical Device Dispute Resolution Panel.
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