FDA provides instructions to manufacturers importing PPE, updates testing FAQs

The Food and Drug Administration today adjusted its import screening to expedite personal protective equipment and clarified types of PPE that can be imported without engaging with FDA. To provide flexibility, FDA will facilitate access to critical legitimate PPE and devices and monitor the import systems to prevent and mitigate potential issues.

FDA established an email, COVID19FDAIMPORTINQUIRIES@fda.hhs.gov, for industry representatives to address questions or concerns. FDA also updated its FAQ on diagnostic testing for SARS-CoV-2 to answer additional questions