FDA advises on increasing supply for PPE

March 24, 2020 By Danielle Kirsh

The FDA today said it is taking action to increase U.S. supplies to support the manufacturing of personal protective equipment and other devices in response to COVID-19.

The FDA said it is facilitating access to critical personal protective equipment (PPE) and devices by engaging with importers and others involved in the import trade community during the pandemic.

Instructions to importers clarify the types of PPE that can be imported without communication with the FDA. It also includes information about the type of information importers can submit to facilitate entries.

The FDA has also adjusted its import screening to expedite imports of legitimate products and will continue to monitor its import systems to prevent errors.

The agency will provide flexibility to manufacturers looking to bring PPE into the U.S. and is available to engage with importers to minimize disruptions during the import process.

A special email inbox has been created for industry representatives to quickly communicate with the agency and address questions or concerns: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov

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