Clinical data in support of U.S. FDA 510(k) submissions
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.