US FDA Recognizes Case For Quality Collaborative Community
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.
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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.
Not Your Grandfather’s CAPA: Case For Quality Pilot Gives Corrective And Preventive Action A Facelift
Big changes are afoot when it comes to CAPA. Ten medtech manufacturing sites are playing in a pilot program that uses a novel framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA. Medtronic quality/regulatory expert Kathryn Merrill weighs in.
CDRH’s Shuren Talks MDUFA, Industry’s Premarket Wants, Emerging Technologies, And More In Wide-Ranging Interview
In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren said the agency will possibly discuss issues such as postmarket surveillance and patient engagement in upcoming MDUFA negotiations. He also talked about some recent big wins for the agency and his vision for the coming year.