Tuesday, March 24, 2020

Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D.
Today, the U.S. Food and Drug Administration took action 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.

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 ...

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