FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers
The U.S. Food and Drug Administration (FDA) 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 (PPE) and other devices.
One of FDA’s priorities in combating the COVID-19 pandemic is facilitating access to critical PPE and devices. They 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. The FDA has adjusted their import screening to further expedite imports of legitimate products and are continually monitoring their import systems to prevent and mitigate any potential issues.
The FDA established a special email inbox, [email protected], for industry representatives to quickly communicate with the agency and address questions or concerns.
The agency is providing maximum flexibility to those seeking to bring PPE into the U.S. and are ready and available to engage with importers to minimize disruptions during the importing process.
Many companies are stepping up across America to help with manufacturing critical and life-saving medical supplies to strengthen the U.S. response. The FDA is setting up additional avenues of communication to the agency for contacting with any questions or concerns around the clock.
