Webinar - FDA decisions for IDE clinical InvestigationsJul. 2, 2013
The Food and Drug Administration (FDA) invites you to join a webinar on its new draft guidance: FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations. Please review the guidance prior to the webinar so that you can be prepared to participate with questions.
Date: Tuesday July 2, 2013
Time: (Israel Time) 18:30-20:00 (EST) 11:30 - 1:30
Following the Webinar, the slides and audio presentation will be posted at http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#ide.
FDA posted the draft guidance on June 13, 2013. This guidance describes FDA’s decision-making and communications regarding applications from companies conducting medical device clinical trials in the US. It outlines new and more flexible options for clinical study approvals that allow studies to begin sooner while assuring patient protections.
Please submit electronic or written comments by September 12, 2013.
Thank you for your continued support of the FDA and its mission.
Food and Drug Administration
Center for Devices and Radiological Health