Biocompatibility and Nitinol Guidances
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidances on biocompatibility submissions and nitinol-containing devices. Although the two are separate guidance documents, we combine them into a single discussion. Specifically, we address a number of questions, including: What is the biocompatibility guidance in regard to?Does this help simplify the pathway to market for commonly used materials that have a prov...