You Got a 483 from the FDA. Now what?

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing what the process should be for a company once they receive a 483 or warning letter from the FDA. Best practices, first steps to take, who is responsible, and potential strategies for avoiding them are shared. Specifically, the following questions are addressed:Could you please explain what a 483 is and what a warning letter is? Are they the same thing?What are some comm...