With supply chains across the globe disrupted, the need to not only manufacture but also import sufficient quantities of personal protective equipment (PPE) for essential workers to keep them safe has become pressing. Today, on March 24, 2020, FDA Commissioner Stephen M. Hahn, M.D., announced the U.S. Food and Drug Administration was taking action to increase U.S. supplies and to support the U.S. response to COVID-19. The instructions to manufacturers provided by the FDA focus on manufacturers importing personal protective equipment and other devices.
One of FDA’s priorities in combating the COVID-19 pandemic is facilitating access to critical PPE and devices by engaging with importers and others involved in the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S. These instructions to importers clarify the types of PPE that can be imported without engaging with FDA. They also include information about the type of information importers can submit to facilitate their entries. Import screening has been adjusted to further expedite imports of legitimate products. Import systems are being continually monitored to prevent and mitigate any potential issues.
The FDA established a special email inbox, COVID19FDAIMPORTINQUIRIES@fda.hhs.gov, for industry representatives to quickly communicate with the agency and address questions or concerns.
The agency is providing maximum flexibility to those seeking to bring PPE into the U.S. and are ready and available to engage with importers to minimize disruptions during the importing process.
Many companies are stepping up across America to help with manufacturing critical and life-saving medical supplies to strengthen the U.S. response. To support their efforts, the FDA has set up additional avenues of communication manufacturers and importers can contact the agency with any questions or concerns around the clock.