AdvaMed: IDE Submissions


During this interactive workshop, FDA Staff Leaders (invited) and Industry Experts will lead professionals through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required. Topics to be discussed include:

– The purpose of an IDE
– Tips on making the best use of pre-submission meetings
– Components of a successful IDE submission
– Common errors and deficiencies in an IDE application
– The ins and outs of BIMO inspections
– Details about the regulatory requirements needed during trial conduct
– And more