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CDRH’s Shuren Says Employee Burnout ‘Great Fear’ During Pandemic

 
• By Elizabeth Orr

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.

CDRH leaders expressed concerns about employee burnout at recent forums.

The ongoing crush of device applications tied to the coronavirus pandemic is stressing systems at the US Food and Drug Association’s device center, top agency officials say.

Center for Devices and Radiological Health (CDRH) director Jeff Shuren spoke at AdvaMed’s Virtual Medtech Conference on 6 October, and at the Food and Drug Law Institute’s (FDLI) annual conference...

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UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
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Zika Virus Test Among 4 New FDA Device Classifications

 
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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
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Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

More from Policy & Regulation

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Pathogen Sharing System Part Of Global Pandemic Agreement

 
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