You Got a 483 from the FDA. Now what?

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 a concern for the company involved?
• What should be considered in terms of the PR hit as a result of a 483 or warning letter?
• Do you have suggestions with regard to preventing a 483 or warning letter?
• Anything more a company should consider and after that, please share what you consider to be the most important takeaways?

Listen to this discussion and see if you have a better handle on what to do if you get a 483 or warning letter. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [e-mail] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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