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

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

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