Obtaining an FDA Investigational Device Exemption - Webinar By GlobalCompliancePanel 2012
20 Nov 2012
Webinar
Key Topics
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
Who should Attend
Physicians conducting research
Medical device developers
Biomedical Engineers
Hospital Administrators
Students doing human research
Biomedical Engineering department chairs
Past Events
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Important
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Event Categories
Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Medical technology, Pharma
