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

March 24, 2020 in COVID-19 Updates HHS/FDA & Other Regulatory by Denise Bell

“March 24, 2020 – 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 manufacturersExternal Link Disclaimer 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 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.”

Read the full article at fda.gov