Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s pre-sub program and best practices for companies to consider prior to their scheduled appointment with the agency. Specifically, we address a number of questions, including:Can you please give a brief overview of what the FDA’s pre-sub program is?Is the pre-sub only for certain types of devices or when using certain regulatory pathways or is it available to all device makers?Are there questions you shouldn’t ask during the pre-sub?What’s the most common mistakes you’ve heard companies made during their pre-sub?Will the FDA help a company determine what regulatory pathway to take during a pre-sub?Will the FDA give recommendations on things such as testing protocols a certain type of device should go through during a pre-sub?Is there any information you shouldn’t share with the FDA during a pre-sub? In other words, can being too transparent hurt you?What’s the most important thing for