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A CDRH Priority: Clinical Trials in the United States

Striving to get U.S. patients fast access to safe and effective medical devices

Owen Faris
Jeffrey Shuren
Mon, 02/09/2015 - 16:46
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At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but also present the greatest risk to patients.

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During the past year, we saw several exciting new medical devices reach U.S. patients, including devices to treat heart disease and diabetes, and diagnose cancer. In January 2015 we approved a new device to treat obesity. None of these products would have come to market without clinical trials.

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