Today FDA announced that it is taking additional measures to increase the availability of personal protective equipment and devices in the face of the COVID-19 pandemic. The agency is working with importers, clarifying the types of PPE that can be imported without “engaging with FDA”, and has altered its import screening to accelerate legitimate product imports.
“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,” said FDA Commissioner Stephen Hahn, M.D. in an agency press release. “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.”
Yesterday CDRH also released a Letter to Industry on COVID-19 that summarizes some of the changes to how the center is prioritizing activities during this public health emergency.