In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re highlighting comments made by FDA representatives at an event about the most common premarket review issues they see in submissions. First, there is some discussion regarding whether the issues are truly premarket or postmarket concerns. Then, we look at what these are, why they are likely so common, examples of them, and how to avoid running into these issues yourself. During this conversation, the following questions are addressed:

• Recently, three medical device senior operations officers from FDA’s Office of Inspections and Investigations spoke at a conference about the most common “issues” FDA encounters during the premarketing review of medical devices. Can you give a recap of what they said?
• In your 30+ years of experience working in the medical device industry, would you agree with FDA that these are the three most common issues?
• Before discussing the three specific common problems individually, what do you think is the “root cause” of these problems?
• Can you provide some examples?
• How can design change and design creep get companies in trouble with FDA?
• What does “marketing beyond authorized intended use” mean?
• Do you have suggestions and/or best practices to avoid running into problems around these issues?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if you've run into these issues yourself. 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 [email protected] and

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