Online Program

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Tuesday, September 26
Tue, Sep 26, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL32: Design and Analysis of Crossover Trials for Medical Devices (300485)

*Bo Zhang, FDA/CDRH 

The idea of planning a crossover clinical trial, in which the patients are arranged to cross over from one treatment to another, is not frequently adopted in the process of evaluating investigational medical devices. However, the Center for Devices and Radiological Health in the U.S. Food and Drug Administration (FDA) still annually receives a number of applications that report crossover trials as their confirmatory clinical trials for evaluating the safety and effectiveness of the new medical devices. We will discuss three FDA-approved Pre-Market Approval submissions (and one 510(k) submission) as the examples that a crossover trial was implemented during the regulatory approval process of medical devices. We will also discuss the key points that the FDA made regarding the design and analysis of crossover trials in its two published documents of guidance for industry. The goal of this discussion is to boost the consistency of the two sides on the understanding of how to design and conduct a crossover trial for investigational medical devices.