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Promises, Promises

CDRH’s strategic priorities promise improved IDE and PMA regulatory climate

Tamar June
Wed, 03/05/2014 - 16:41
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The Center for Devices and Radiological Health (CDRH) will focus on encouraging medical device innovation and speeding clinical trials in the coming years, according to its 2014–2015 Strategic Priorities report released Feb. 5, 2014. To help encourage that innovation, CDRH says it’s going to work to improve the Investigational Device Exemption (IDE) process, especially in the areas of consistency and speed with which it handles applications.

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CDRH also pledges to find ways to encourage more early IDE studies—especially for those with medical devices aimed at the U.S. patient marketplace. The report says CDRH will try to find a better balance between premarket and post-market data requirements.

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