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 sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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For more medtech news and information, visit www.mpomag.com.

You Got a 483 from the FDA. Now what?

Medtech Matters

You Got a 483 from the FDA. Now what?