Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the following questions are addressed:First, can you please explain what is out-of-bounds? (i.e., What will we NOT talk about?)What can FDA do during the shutdown?If a company currently has a submission under review, pending communications (e.g., emails, questions, pre-submission meetings), or other activities currently pending with the Agency, what would you advise the company to do? How should they proceed?If a company plans to make a submission, request a pre-submission meeting, or engage with FDA about other activities in the n