Results for tag: "Investigational Device Exemption"

The Investigational Device Exemption (IDE) market is a subset of the medical device industry. It refers to the process of obtaining approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials of medical devices. The IDE process is designed to ensure that the safety and effectiveness of the device is established before it is made available to the public. The IDE process involves submitting an application to the FDA, which includes information about the device, the proposed clinical trial, and the safety and efficacy data. Once approved, the device can be used in clinical trials. Companies in the IDE market include Abbott, Boston Scientific, Medtronic, Stryker, Johnson & Johnson, and Philips. Show Less Read more