Breakthrough Designation Program Update
Medtech Matters - En podkast av Medical Product Outsourcing - Tirsdager
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss how the breakthrough designation program has changed since its inception. While the language of the program has not changes, FDA’s interpretation of it has shifted somewhat. Find out what’s “new” in this episode. Specifically, we address a number of questions, including:Can you remind us what the BDP is? Why was it created? Who should consider it?How is the 510k pathway able ...
