New FDA Priorities for Medical Device Clinical Trials: A Free Webinar
June 9, 2021 | 1 PM ET- 1:45 PM ET

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.

Join Thompson FDA on June 9th at 1:00pm ET 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, and
  • 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.

Don’t miss this free webinar 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!

Can't make the live event? Fill out the form anyway and we'll send you the recording.


Meet Your Webinar Leader:

Dennis Tosh, Thompson FDA

Dennis Tosh has served as the editor of Thompson FDA publications for more than 18 years, including Thompson's FDA Enforcement Manual, Guide to Medical Device Regulation, and Controlled Substances Handbook. He has more than 26 years of legal editing and journalism experience, covering a range of topics including food and drug law, environmental law, wage hour law, and compensation and benefits. Before beginning his career as a legal editor, he practiced law for five years in Washington, D.C. He earned his Bachelor of Arts, Master of Arts in English, and Juris Doctor degrees from the University of Virginia, and he is a member of the Virginia State Bar and the District of Columbia Bar. You may connect with him via LinkedIn.

Who Should Attend:

This webinar is of value to anyone involved in legal or regulatory compliance or enforcement issues related to clinical trials for medical devices, including those working with:

  • Study sponsors
  • Research sites
  • Contract research organizations (CROs)

 

 
 

Fill In The Information Below To Attend: