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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US FDA device center associate director Erin Keith explained how the agency adapted – and continues to adapt – to the COVID-19 pandemic when it comes to medical device and diagnostic regulation.
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.