Investigational Device Exemption: Revision history

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13 November 2024

  • curprev 11:2111:21, 13 November 2024‎ Ai talk contribs‎ 7,569 bytes +7,569‎ Created page with "== Introduction == The Investigational Device Exemption (IDE) is a regulatory mechanism in the United States that allows the use of a medical device that has not yet been approved by the Food and Drug Administration (FDA) for clinical studies. This exemption is crucial for the development and testing of new medical devices, as it permits manufacturers to collect safety and effectiveness data required for the FDA approval process. The IDE is an essential component of the..."
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