Investigational Device Exemption (IDE) Workshop
This course will offer best practices when conducting trials using FDA approved and non-approved devices. It will cover the IDE application process and the obligations of the sponsor-investigator once the IDE application is filed with the FDA.
Event details
When
May 24, 2012
from 01:00 PM to 04:00 PM
from 01:00 PM to 04:00 PM
Where
Brinkhous-Bullitt, Room 219
Contact Name
Contact Phone
9198432883
What you can expect from the IDE workshop...
- Definition of a medical device
- Examples of when an IDE is required by the FDA
- What are PMA, 510k, and other terms used in device regulations?
- What is an abbreviated IDE and when is this applicable?
- What is the difference between an abbreviated IDE and a “full” IDE and when is the
- “full” IDE applicable?
- How do I submit my IDE application to the FDA?
- How do I maintain the IDE once it’s filed with the FDA?
- How and when should I report Serious Adverse Events (SAEs) once I hold the IDE?
- Is my trial required to be registered on Clinicaltrials.gov?
Filed under:
Presentation
