Medtech Matters
Medtech Matters
Medical Product Outsourcing
3 Most Common Premarket (Postmarket?) Review Issues FDA Sees
53 minutes Posted Jun 25, 2025 at 1:00 pm.
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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 thi...