As the U.S. continues to battle the novel coronavirus (COVID-19), first responders, health care professionals and other essential workers on the front lines continue to deal with a shortage of personal protective equipment (PPE). With nationwide PPE shortages, numerous companies are looking to help by importing PPE. Our team explains the new FDA regulations associated with importing PPE.
We remain committed to compiling and releasing critical information as it’s made available. As such, we recently published key details to help importers navigate the new FDA guidelines related to the importation of general use and medical use personal protective equipment (PPE) as well as the Emergency Use Authorization (EUA). Below is a summary of the key details importers should be aware of before importing PPE.
Personal protective equipment (PPE) and other medical products are broken up into classes according to:
Furthermore, there are three primary PPE classes:
The EUA authority essentially allows the U.S. Food and Drug Administration (FDA) to relax certain requirements related to the production and use of medical products. The EUA is intended to expedite stockpile replenishments during emergencies, such as COVID-19, when there are not adequate, approved or available alternatives.
Dependent upon the class, specific data or flags must be transmitted to the FDA. For example, medical use PPE requires FDA Product Codes and Intended Use Codes to be transmitted.
However, if medical use PPE authorized by the EUA is imported, certain FDA information is not required for review. An example includes reduced requirements related to Affirmation of Compliance codes, such as:
The government acknowledges that it will require a “Herculean logistical effort” to get PPE to those who need it the most. As global demand for this equipment is at unprecedented levels, importers are working as quickly as possible to deliver PPE to those that need it.
Ascent Global Logistics is continuously gathering the latest information on COVID-19 and FDA regulations related to PPE supplies. We will continue to compile valuable information for the import and transportation community.