Module 15 2022

19/05/2022

Lecture 9: Clinical Global Strategy Requirements – Focus on US FDA Specifics

Carla Wiese NAMSA Product Development Strategist

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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• Planning & guidance to help think strategically • Benefit Risk assessments • Early Feasibility US IDE program • Breakthrough Technology Designation / Safer Technology Designation • Use of foreign data in FDA submissions • IDE Submissions • Benefits of Pre-submissions • IDE requirements • Other Considerations • Clinical study size for PMA/Class III devices: US versus EU • Diversity Planning Agenda

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

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