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Shuren: FDA Making ‘Pre-Cert Simulator’ To ‘Test Drive’ Regulatory Frameworks For Digital Health Tech

Device center director also ponders whether the agency’s Pre-Cert Program could cover a wider array of products in the future

 
• By Shawn M. Schmitt

US FDA device center director Jeff Shuren said on 6 October that the agency is developing a “precertification simulator” that will allow it to assess different regulatory frameworks in the digital health space.

CDRH Director Jeff Shuren
CDRH director Jeff Shuren at last year's in-person AdvaMed MedTech Conference • Source: Ferdous Al-Faruque

The director of the US Food and Drug Administration’s device center says it’s making a “precertification simulator” that will allow it to assess different regulatory frameworks in the digital health space without the need to cobble together physical pilot programs.

“We’re … building today, under the auspices of the [FDA’s new Digital Health] Center of Excellence, a precertification simulator so...

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