This article summarizes the requirements for transitioning medical devices, marketed with lowered standards for effectiveness under emergency use authorization (EUA) during the COVID-19 pandemic, after the EUA declaration expires. These policies may evolve as the US Food and Drug Administration (FDA) awaits declaration from the secretary of Health and Human Services (HHS) stating that the pandemic has ended. The author suggests this limited oversight of the manufacture of medical devices and the lowered expectations for device effectiveness may affect future requirements for objective evidence for marketing submissions after EUAs have been terminated and diagnostics for COVID-19 undergo increased scrutiny by the Agency for marketing authorization. The scope of this article covers medical devices with published enforcement discretion policies from the FDA and those authorized under EUAs during the COVID-19 public health emergency.