Medtech Matters

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