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Shuren Gives Peek Behind Curtain With 3 Lessons FDA’s Device Center Learned During Pandemic

 
• By Shawn M. Schmitt

CDRH director Jeff Shuren says the US agency’s device center has been tallying up lessons learned from the COVID-19 pandemic.

woman with a backstage pass looking behind the red curtains on a stage

Jeff Shuren says the US Food and Drug Administration’s device center has been tallying up lessons learned from the coronavirus pandemic.

“COVID-19 has presented challenges for the world, our country and the FDA,” the director of the Center for Devices and...

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The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
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Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

More from Policy & Regulation

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 
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More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?