In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss recent coverage of a two-minute COVID-19 test that had miscommunicated obtaining emergency use authorization from the FDA. We look at actions the FDA is taking around these types of incidents and also about the potential issues with a relaxing of regulatory rules around certain products during this pandemic. Specifically, we address a number of questions, including:

• We saw a 2-minute COVID-19 test being reported on that incorrectly claimed to have Emergency Use Authorization. The company claimed a misunderstanding. What should companies be doing to ensure they don’t make this mistake as well?
• Is there a concern of future misunderstandings from companies seeking to help, but not accustomed to working with the FDA?
• Does a company who has gained an EUA for a new device still need to seek a traditional regulatory pathway for approval/clearance?
• What does the FDA’s relaxing of regulatory rules mean to medical device manufacturers?
• Reports on the mortality rate for patients put on ventilators differs greatly, but in looking at a fair amount of data, it seems the number is approximately 66 percent. As a result, is the race to make more ventilators the best action or are we really without another choice at this stage since we don’t know who will survive and who won't?
• Is the FDA taking action against any type of misinformation and/or outright lies about a product’s ability to help address COVID-19?

Listen to this episode and see what you think of the concerns brought up regarding the effort against COVID-19. 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 can address your ideas/inquiries/suggestions in a future episode.

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