Working with Investigational Form

Instructions and help about Working With Investigational

it's nine o'clock we're going to go ahead and get started good morning everyone my name is melissa green and i'm a regulatory affairs scientist here at duke within the office of regulatory affairs and quality first i wanted to welcome you all and thank you for joining our best practices workshop for the preparation submission and maintenance of sponsor investigator indeed and ides so today we're going to be presenting part two of a two-part series the first part was presented last week on inds and today we'll be discussing investigational device exemptions i'll be presenting part one and my colleague david jensen will be pursuing part two so before we get started you can use the question and answer function to ask any questions and direct them to our coast who is kelly limbleum just as a disclaimer we do have quite a bit of ground to cover in part one of this presentation so we'll go ahead and jump right into things momentarily if you have questions feel free to ask them throughout the