Module 15 2022

19/05/2022

My device is novel, can I expedite the process?

The Organisation for Professionals in Regulatory Affairs

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Guidance that help clinical strategic thinking: Breakthrough Technology Designation

• Expedite device

development and review for certain medical devices • Work with sponsors to define a roadmap from early stages of device development to FDA marketing authorization • Breakdown perceived barriers • Collaboration & interaction

The Organisation for Professionals in Regulatory Affairs

12

6