On August 18, 2014, the Food and Drug Administration (FDA) issued a final guidance document, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.”
The final guidance describes the FDA’s decision-making and communications regarding applications from companies that want to conduct medical device clinical trials in the U.S. It also describes more flexible options for clinical study approvals that allow clinical studies to begin sooner while ensuring patient protections.
Tomorrow, September 4, 2014 the FDA will hold a webinar to explain the guidance and to provide a forum for asking questions you may have. Registration is not necessary.
Thursday, September 4, 2014
1:00-2:30 p.m. Eastern Time
To ensure you are connected, log-in by 12:45 PM.
To hear the presentation and ask questions:
Dial: 888-972-7807; passcode: 1405152
To view the slide presentation during the webinar:
Conference number: PW8306690
Following the webinar, a transcript, recording and slides will be available at:
Please note: the slide presentation will also be available at this site on the morning of the webinar.
If you have any questions regarding this guidance, please contact Owen Faris, Clinical Trials Director (acting) at firstname.lastname@example.org, or the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1.800.638.2041, 301.796.7100 or email@example.com.