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 acting commissioner Janet Woodcock says the use of real-world evidence in product reviews will be slower than many of its supporters are hoping because there are a number of problems that still need to be addressed.
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.