During this interactive workshop, FDA and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required.
Agenda topics 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!