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The Investigational Device Exemption (IDE) Workshop

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Wednesday, April 11, 2018
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9:00 am - 12:00 pm
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Kelly Lindblom, PhD, RAC & Sarah Gemberling, PhD, RAC

Discuss FDA's approach to regulation of devices in clinical studies and for marketing.

Provide guidance on when the IDE regulations apply and discuss possible exemptions

Review significant risk and non-significant risk device studies

Discuss the preparation, submission, and maintenance of IDE applications

Encourage participant discussion of case scenarios

Contact: Susan Nagorski