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Devices & Diagnostics Letter
Nov. 14, 2011 | Vol. 38 No. 45
FDA Issues Two Guidances to Boost First-In-Human Studies
The FDA proposes to streamline device clinical trials in a pair of draft guidances outlining requirements for early feasibility studies and explaining when a trial can begin even when there are outstanding issues with an Investigational Device Exemption (IDE) submission.
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