To help ensure that the United States has the necessary medical supplies during the COVID-19 crisis, the U.S. government has taken actions to help secure access to certain PPE and medical devices. Here are some key actions taken, with emphasis on how these actions impact the importation of PPE into the United States.
PREP Act Declaration
On February 4, 2020, the Secretary of the Department of Health and Human Services issued a Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19. This declaration authorized the emergency use of certain medical supplies. Pursuant to this declaration, an emergency use authorization, or EUA, now has been applied to air-purifying respirators, various face filtering respirators, certain decontamination systems, N95 respirators, certain sterilization products, and face masks.
FDA Regulation of PPE Imports
On March 24, 2020, the United States Food and Drug Administration (FDA) issued instructions to manufacturers that import PPE and other devices. These instructions outline the PPE that can be imported without having to engage with the FDA. They also provide details about the information needed to facilitate the entry of PPE.
Further, although many PPE are regulated by the FDA, a general theme in this correspondence is that the FDA is given maximum flexibility, allowing itself to be accessible to importers of PPE in order to limit any disruptions of importing these supplies.
The FDA’s instructions specify which PPE can be imported without FDA regulations. These are known as “general purpose” PPE. PPE not classified as general-purpose are regulated by the FDA, including masks, respirators, gloves, and protective gowns. These items require FDA registration prior to importation.
In order to help ensure that medical facilities and medical providers have the necessary supplies to address the COVID-19 crisis, the government has made some changes to how PPE are imported and used. As a result, the importation of PPE to the United States has become more complicated and regulated. And, what can be even more challenging for businesses is the fact that these regulations seem to be changing rapidly.
At ClearFreight, we’re closely watching all changes that impact logistics and are prepared to help clients navigate all aspects of logistics. Contact us for help with importation, with any logistics questions or concerns, or for support to help things run as smoothly as possible during these challenging times.