Obtaining an FDA Investigational Device Exemption - Webinar By GlobalCompliancePanel 2012

Obtaining an FDA Investigational Device Exemption is a webinar that covers topics such as:

• Meaning of "Intended Use"
• Definition of "Medical Device"
• Institutional Review Boards
• "Research" vs. " Treatment
• An IDE Without an FDA Application
• CFR 812
• Contents of an Application for an IDE
• The Sponsor - Investigator Relationship
• Device "labeling" defined, required
• The Investigational Plan
• Laboratory Data
• Informed Consent Requirements
• Time Frame for FDA Response

Obtaining an FDA Investigational Device Exemption brings together:

• Physicians conducting research
• Medical device developers
• Biomedical Engineers
• Hospital Administrators
• Students doing human research
• Biomedical Engineering department chairs