Module 15 Presentations

15/04/2024

Acceptability differs from applicability/suitability

Unwritten - ~50% clinical data from US patients – depends on device type

The Organisation for Professionals in Regulatory Affairs

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Use of Foreign Data Guidelines and Suggestions

• For US market plans and patient population, understand FDA’s position on clinical data generated OUS to maximize opportunity to leverage OUS data • Review US Early Feasibility IDE route and compare to other options, to ensure there is no missed opportunity to a US-first approach • In OUS Feasibility/pilot studies assure getting appropriate information related to US population in order to design a meaningful pivotal study • Apply appropriate GCP compliant procedures to early phase studies when they have potential to support submissions to FDA • Be aware : quality of data is important; overall clinical applicability and suitability of the data to answer FDA questions are equally important

• Discuss and get agreement with FDA on use of OUS data before beginning study

• FDA is usually amenable to joint US/OUS studies if not full OUS studies

• Mitigate your risks of acceptance by performing a full GCP assessment/audit

The Organisation for Professionals in Regulatory Affairs

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