FDA Proposes 180-Day Transition before Terminating COVID-19 EUAS, Enforcement Policies

The US Food and Drug Administration (FDA) is proposing to give medical device makers 180-days’ notice before terminating emergency use authorizations (EUAs) and phasing out its enforcement policies for medical devices issued during the COVID-19 public health emergency (PHE).

The transition plan comes in the form of two draft guidances issued in late December, in which FDA explains that the transition policies are intended to “prepare manufacturers and other stakeholders for the transition to normal operations and foster compliance with applicable requirements under the [Federal Food, Drug, and Cosmetic Act] and implementing regulations when the relevant EUAs and COVID-19-related enforcement policies cease to be in effect.”

FDA has issued EUAs for a vast array of medical devices during the pandemic including ventilators, infusion pumps, personal protective equipment, in vitro diagnostics and more.

Source: https://www.raps.org/news-and-articles/news-articles/2022/1/fda-proposes-180-day-transition-before-terminating