Summary: 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.
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
Target Audience: Medical Device Industry, Medical Device Developers, Medical Device Industry Associations, Researchers, Academia
Registration is not required for this webinar.
Date: January 22, 2015
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:
Conference number: PW1052941
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.