CDRH’s Shuren Says Employee Burnout ‘Great Fear’ During Pandemic
The US FDA’s device center has reassigned staff and let some product reviews fall to the back burner while it grapples with a crush of new product applications tied to COVID-19.
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The Case for Quality Collaborative Community – or CfQcc – affords stakeholders across industry a safe space where they can rally around an array of topics to advance medical device quality and safety.
CDRH director Jeff Shuren says the US agency’s device center has been tallying up lessons learned from the COVID-19 pandemic.
FDA advisory committee members said the trial population was too small and homogenous and did not establish that Neovasc’s Reducer effectively treats angina.