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Clinical Data in Support of U.S. FDA 510(k) Submissions

Learn how the U.S. Food and Drug Administration (FDA) requires evidence that a medical device is as safe and effective for its intended use as a legally marketed device.

Stethoscope laying on a printed bar graph

Clinical trials are time-consuming, expensive, and complex. It's critical to comprehend precisely which issues must be resolved to meet the FDA's requirements when a clinical trial is needed to support a medical device regulatory submission. Therefore, it is advised that experts be included in the clinical trial's design, monitoring, and regulatory requirements verification. These experts can also assess whether real-world evidence may be used to offer the essential proof. Additionally, scheduling a Q-Submission meeting with the FDA is strongly advised. 

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