Despite the FDA’s need to shift priorities in response to the COVID-19 pandemic, the number of novel medical devices that the agency has approved, cleared, or authorized for marketing has actually increased during the public health emergency. And, the FDA has continued to advance programs that encourage innovation in clinical trials for devices, including increased flexibility in trial design and statistical analysis.

Download this free resource to learn about:

• Recent FDA initiatives that can help augment the evidence from traditional device trials that product sponsors can use to support their premarket submissions to the agency
• The latest on the use of real-world evidence and instruments that capture patient-reported outcomes
• The FDA’s expectations for using these tools and their roles in the agency’s regulatory decision-making

Plus, you’ll hear about critical issues arising from the increased use of digital health technologies such as apps in clinical research, recent FDA Warning Letters issued to investigators involved in device trials, and important upcoming rulemakings focused on clinical holds in device investigations and on IRB waivers or alterations of informed consent for minimal-risk trials.

Download this free resource from Thompson FDA on the latest priorities out of the Food and Drug Administration, so that you can ensure that your medical device clinical trials employ best practices to help speed the devices to market!

This free webinar was recorded on June 9, 2021.