PPE and Device Manufacturers: FDA Offers Import Instructions

To increase U.S. supplies, FDA is providing instructions and a specific email address to get questions and concerns addressed quickly.

Gettyimages 107907121 2

In a statement from FDA Commissioner Stephen M. Hahn M.D., the FDA announced it is providing instructions to manufacturers importing personal protective equipment (PPE) and other devices.

The agency recognizes that access to PPE and devices is critical for healthcare providers. “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.,” says Hahn. “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.”

Fresh from the show floor: pharma packaging innovations for 2026
Serialization mandates. Containment demands. Sterile barrier requirements. Our editors found the pharma packaging innovations addressing your biggest challenges at PACK EXPO Las Vegas. Get your free curated report now.
GET YOUR COPY
Fresh from the show floor: pharma packaging innovations for 2026