On March 27, 2023, the U.S. Food &Drug Administration (FDA) released two final guidance documents to assist with the transition of medical devices that were legally distributed: (1) subject to certain enforcement policies issued during the COVID-19 public health emergency (PHE) or (2) Emergency Use Authorizations (EUAs). Manufacturers, distributors, and industry stakeholders that have products subject to one of these pathways should review the agency guidance if they wish to continue marketing the products. If an entity is not sure whether an EUA applies to a product, FDA has generated a full list at this site.
On January 31, 2020, the Department of Health and Human Services (HHS) first determined a public health emergency (PHE) existed because of COVID-19. This PHE determination has been renewed many times, the most recent on February 9, 2023. However, change is approaching for the regulated industry since HHS recently announced that it is preparing to declare an end to the PHE for COVID-19 on May 11, 2023. As a result, certain industry sectors will be impacted, particularly those that manufacture or distribute medical devices subject to FDA enforcement polices and EUAs issued during the PHE.
During the PHE, the FDA issued numerous EUAs and enforcement policies allowing manufacturers to quickly develop and distribute products such as masks, medical devices, and ventilators. The EUAs and enforcement policies provided flexibility for manufacturers to avoid the standard requirements for medical devices, such as premarket notifications, that otherwise could lead to significant delay in reaching the market. These flexibilities helped non-traditional manufacturers to provide much-needed medical devices to aid in the nationwide COVID-19 response.