Vivos Inc (RDGL)

[jeffshir]

FDA Webinar

In an effort to ensure that patients in the U.S. have access to high-quality, safe and effective medical devices, the medical device clinical trials program at the FDA has undergone many changes. Some of these changes include issuing guidance documents and revising organizational structure and policies. Although we’ve communicated these changes individually, this event will provide you an opportunity to hear about the current medical device clinical trials program, outlining where we are now and where we are going.

On January 22, 2014 from 1:30 PM – 3:00 PM, Eastern Time, the FDA will hold a webinar to provide an overview of the Medical Device Clinical Trials Program. Participants will also have an opportunity to ask questions.

Topics to be covered during the webinar:

Clinical Trial Strategic Priority
IDE SOP Implementation
FY14 Performance and FY15 Performance Goals
Early Feasibility Studies
Future Program Plans
Webinar Details:
Date: January 22, 2014
Time: 1:30 PM – 3:00 PM, Eastern Time
To ensure you are connected, log-in by 1:15 PM.

To hear the presentation and ask questions:
Dial: 800-369-1937; passcode: 5211887
International: 1-312-470-7075; passcode: 5211887

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PW1052941&p=5211887&t=c

Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar
Please Note: the slide presentation will also be available at this site on the morning of the webinar.

If you have any questions about the webinar, please contact CDRH Learn.

To view past webinars on clinical trials and other topics, please visit: www.fda.gov/CDRHWebinar

Food and Drug Administration
Center for Devices and Radiological Health