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Digital Health: FDA’s Shuren Predicts ‘Critical Regulatory Hurdles’ If Congress Doesn’t Update Reg Frameworks

 
• By Shawn M. Schmitt

US FDA device center director Jeff Shuren is strongly urging lawmakers to come up with modern digital health regulatory frameworks and more strongly tackle cybersecurity issues.

businessman standing in front of a row of railings
• Source: Shutterstock

The director of the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is warning of “critical regulatory hurdles” if Congress doesn’t soon update reg frameworks for digital health products.

Speaking on 4 May at AFDO/RAPS MedCon Conference 2022, Jeff Shuren said today’s frameworks don’t cut the mustard and that lawmakers need to act.

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