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FDA releases draft IDE guidance including new Pre-Decisional IDE process

21 June 2013

Medical Device Alert

The Food and Drug Administration’s (FDA or the Agency) Center for Devices and Radiological Health (CDRH) released draft guidance aimed at helping companies design studies that are more likely to support successful marketing applications in the future.

Read more: FDA releases draft IDE guidance including new Pre-Decisional IDE process

The team

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