They say that necessity is the mother of invention. But, historically, invention has never been the problem for creators of novel medical devices; the real challenge for these inventors has been more about getting the regulatory approval necessary to bring their creations to market. And the necessity imparted by the pandemic offered unprecedented opportunity to meet that challenge with the U.S. Food and Drug Administration (FDA) authorizing a record-high number of novel medical devices in 2020. The Emergency Use Authorization Factor Despite a slight dip in 2019, new medical device approvals have been steadily trending upward over the past decade. Even so, what occurred in 2020 represents an aberration from previous patterns, as total FDA new medical device approvals completely crushed the previous high of 2017. Of course, the major reason for the spike is that the 2020 totals include not just full-blown clearance but also emergency use authorization (EUA), a less rigorous pathway to approval that the FDA uses in response to public health emergencies. Although this was hardly the first time that the opening of the EUA pipeline benefited medical device makers, the COVID-19 crisis was—and remains—bigger and more urgent than any previous public health emergency to arise […]