FDA Takes Action To Increase U.S. Supplies In Response To Covid-19

The U.S. Food and Drug Administration (FDA) has taken action to boost the U.S. supplies for supporting the response to the coronavirus (COVID-19) pandemic through instructions to manufacturers importing personal protective equipment (PPE) and other medical device, according to a statement from Stephen Hahn M.D., Commissioner of Food and Drugs of FDA.

The U.S. is facing a severe shortage of PPE such as N95 mask, which blocks at least 95 percent of very small test particles, as the coronavirus cases skyrocket in the U.S., and the doctors and nurses are forced to work without masks or reuse them.

The Centers for Disease Control and Prevention or CDC does not recommend that the general public wear N95 respirators to protect from such illness. They are, rather for healthcare workers.

In order to provide access to critical PPE and devices, the FDA is engaging with importers and others involved in the import trade community to facilitate the import of these products into the U.S. to help health agencies with critical equipments.

Many companies across the U.S. have already shown interest in helping with manufacturing of critical and life-saving medical supplies.

The FDA said it is providing maximum flexibility to those seeking to bring PPE into the U.S. and are ready to engage with importers to minimize disruptions during the importing process.

The agency has adjusted its import screening to further expedite imports of legitimate products and is continually monitoring its import systems to prevent and mitigate any potential issues.

The instructions provided by the FDA to importers clarify the types of PPE that can be imported without engaging with FDA such as non-FDA-regulated general purpose PPE such as masks, respirators, gloves.

The instructions also include information about the type of information importers can submit to facilitate their entries. The FDA said importers should transmit entry information to US Customs and Border Protection (CBP) at the time of entry for these products.

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