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US user fee structure takes shape, but funding will have to wait

This article was originally published in Clinica

Executive Summary

The US FDA's device centre, the CDRH, has taken the first step towards implementing the new device user fees by naming an official in the Office of Device Evaluation (ODE) to lead the programme. Joanne Less, currently director of both the investigational devices exemptions programme and the humanitarian device exemption programme, will fill the role.

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