We provide comprehensive support for IDE submissions, assisting manufacturers in obtaining FDA approval for the clinical investigation of high-risk medical devices, ensuring compliance with regulatory requirements and facilitating a smooth approval process.
Preparing a successful Investigational Device Exemption (IDE) submission is crucial for medical device sponsors planning U.S. clinical trials. An FDA IDE allows a company to legally evaluate an investigational (not-yet-approved) device in humans by exempting it from certain regulatory requirements during the study. In essence, obtaining an IDE is the gateway to gathering the clinical evidence needed for a future marketing application (often a PMA or sometimes a 510(k) with clinical data). Because an IDE trial typically represents the first time a device is used in humans under regulatory oversight, it’s essential to get the process right – from determining if you need an IDE, to preparing a thorough application, to managing compliance once the trial is underway.
Each of the guides below targets a key aspect of the IDE process. They cover everything from understanding when an IDE is required (e.g. differentiating significant risk vs. non-significant risk studies), through the step-by-step submission requirements and FDA’s 30-day review timeline, to strategies like Pre-Submissions that can improve your IDE application’s success. Whether you are a startup, an international manufacturer, or any sponsor new to FDA’s clinical trial requirements, these resources will help you navigate IDE submissions with clarity and confidence, ensuring you meet all FDA obligations while advancing your device development.
