Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a variety of ways in which medical device manufacturers communicate with the FDA. Mike provides best practices he’s used and also shares stories from his own experience interacting with the agency for real-world projects. Specifically, we address a number of questions, including:Let’s review the more common or well-understood methods of communicating with the FDA.Regulatory submissionResponse to inspection or 483Pre-sub meetingSocial mediaLetter to fileWhat other methods are there outside of those?How has communication been handled during the pandemic?Can you share best practices when communicating with the FDA? Dos and don’ts?What ways would you like to see established for communication with the FDA?Listen to this episode and see what you think of communication with the FDA and if there are methods you could use which you aren’t. If you’d like to share thoughts, ask questions, or have a sugg