The U.S. Food and Drug Administration (FDA) has provided instructions to manufacturers importing personal protective equipment (PPE) and other devices to increase supplies to support the COVID-19 response.
The instructions clarify the types of PPE that can be imported without engaging with the FDA. They also include information about the type of information importers can submit to facilitate their entries. The FDA is providing maximum flexibility to bring PPE into the U.S. The agency is ready and available to engage with importers to minimize disruptions during the importing process.
“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.,” FDA officials said.
Many companies are stepping up to help with manufacturing the needed medical supplies. To support their efforts, the FDA established a special email account — COVID19FDAIMPORTINQUIRIES@fda.hhs.gov — to quickly address questions and concerns.
The FDA is an agency within the U.S. Department of Health and Human Services that protects the public health by assuring the safety and effectiveness of drugs, vaccines, medical devices, and other biological products for human use. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.