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Device Review Program Faces Organizational Changes; User Fees Coming?

This article was originally published in The Silver Sheet

Executive Summary

NOVEL DEVICE PREMARKET REVIEW OPTIONS will be a primary focus of the Center for Devices and Radiological Health’s new office dedicated to in vitro diagnostic products. The IVD office will embody the device center’s "total product life cycle" approach to regulating products, which seeks to eliminate the division between premarket and postmarket activities. A new division devoted to cardiovascular devices, new leadership and the possibility of user fees are among the changes facing the CDRH’s Office of Device Evaluation. Meanwhile, ODE looks for ways to improve its expedited and modular PMA options and to encourage greater use of abbreviated 510(k)s and third parties

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