Module 15 Presentations

15/04/2024

Planning

Claims, Risks & Benefits Reimbur sement

De Novo 510(k) PMA

I nvest. D evice E xempt

Q-subs:

Use of OUS data

The Organisation for Professionals in Regulatory Affairs

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Conclusion for Clinical Studies Performed in U.S.

• United States is only country with a single Regulatory Authority – clinical studies managed by same Agency • Pathways exist for early feasibility studies to allow initial evaluation for future pivotal study(ies) • Communication and feedback for clinical trial design and planning can be done anytime and is encouraged • Types and amounts of scientific evidence (clinical evidence) depend on many factors including novelty of device • Clinical data outside United States can be used; confirm with the Agency on amount and approach

The Organisation for Professionals in Regulatory Affairs

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