May 24, 2012
from 01:00 PM to 04:00 PM
|Where||Brinkhous-Bullitt Building, Room 219|
|Contact Name||Lori Smith|
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This workshop will address the following information:
- 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?
- Roundtable discussion about the IDE process and general questions from participants
Filed under: CTSA