What Does IDE Stand For?

IDE stands for Investigational Device Exemption CDRH

IDE, or Investigational Device Exemption, is a regulatory pathway established by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). It allows manufacturers to conduct clinical trials involving medical devices that have not yet received full FDA approval. The IDE provides the necessary framework to collect safety and effectiveness data, enabling the assessment of the device's performance in a controlled environment while ensuring participant safety and compliance with regulatory standards.

Other Meanings for IDE