Combination Products Update—Mike on Medtech

Combination Products Update—Mike on Medtech

Mike Drues and Sean Fenske discuss a recently issued compliance program and what it means for manufacturers of combination products.

By Sean Fenske, Editor-in-Chief07.09.20
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact of a new compliance program with regard to inspections for combination products. The impact to the device manufacturers of this type of product is examined following an introduction to what combination products are. Specifically, we address a number of questions, including:

  • What are combination products? What are the different types?
  • The FDA recently issued a new compliance program which included its approach to inspections for combination products. What exactly does that mean? What is the compliance program being referred to here?
  • What are the most important details to manufacturers of combination products, whether drug/device or biologic/device?
  • Does any of this represent a drastic change in how things were performed previously?
  • What are the most important takeaways with regard to regulatory changes for manufacturers of combination products?

Listen to this episode and see what you think of this guidance and determine if it impacts your company and your products. 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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