The “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations” draft guidance describes new approaches to early feasibility studies in an effort to foster early-stage development of medical devices.
The “Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, including First in Human (FIH) Studies” draft guidance outlines the FDA’s process for approving applications from companies wanting to conduct clinical trial involving medical devices.
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