In a statement from FDA Commissioner Stephen M. Hahn M.D., the FDA announced it is providing instructions to manufacturers importing personal protective equipment (PPE) and other devices.
The agency recognizes that access to PPE and devices is critical for healthcare providers. “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.,” says Hahn. “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.”
A special email inbox has been set up to facilitate fast communication for industry representative with questions or concerns: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov