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 near future (but has not done so yet), what would you advise the company to do? How should they proceed?
• Can a company submit a pre-sub request during this shutdown?
• From a public policy perspective, how could situations like these be mitigated or possibly prevented in the future?
• What additional thoughts/questions/comments/concerns/recommendations/etc. do you think are important to share regarding the shutdown and its implications on medical device companies in particular and regulatory affairs in general?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if you can take action during the shutdown. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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