The U.S. Food and Drug Administration took action March 24 to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices, according to FDA Commissioner Stephen M. Hahn, M.D.
One of FDA's priorities in combating the COVID-19 pandemic is facilitating access to critical personal protective equipment (PPE) and devices. We are 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. We have adjusted our import screening to further expedite imports of legitimate products and are continually monitoring our import systems 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, we are setting up additional avenues of communication to FDA so they can contact us with any questions or concerns around the clock.
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FDA initiates increase in US supplies for COVID-19 via instructions for PPE, device manufacturers. Appl Rad Oncol.