Medtech Matters

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 common reasons or examples of why a company would get a 483 or warning letter?What are the first steps for a company that has just received a warning letter or 483?Who is responsible for the response to a 483 or warning letter? Does this fall to regulatory? Quality? Who really should be responsible for addressing it?Is it common for a company to get a warning letter or 483 for the same issue? If that happens, what then should the company do?What’s worse than a 483 or warning letter? Is there a higher level that really causes