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IATI - Israel Advanced Technology Industries
IATI - Israel Advanced Technology Industries
IATI News & Events Events Calendar Webinar - FDA decisions for IDE clinical Investigations

Webinar - FDA decisions for IDE clinical Investigations

Jul. 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The Food and Drug Administration (FDA) invites you to join a webinar on its new draft guidance: FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.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.


Webinar Information

Date:  Tuesday July 2, 2013

Time:  (Israel Time) 18:30-20:00      (EST) 11:30 - 1:30


Audio: 888-790-1891

Passcode: CDRH


Video:  https://collaboration.fda.gov/ide_clinical_guidance


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FDA posted the draft guidance on June 13, 2013.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

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