According to Cargo Systems Messaging Service (CSMS #42448725) titled: Information for Filing Personal Protective Equipment and Medical Devices During COVID-19.
Today the FDA provided an update for instructions to importers of personal protective equipment and certain other devices.
General purpose (non-FDA-regulated) personal protective equipment such as masks, respirators, gloves, etc or for industrial use (ie not to prevent disease or illness) is not regulated by the FDA, and as such entry information does not need to be transmitted to the FDA. The entry paperwork only needs to include the correct HTS code and the importer or customs broker should include the FD1 flag and “disclaim” for FDA.
On the other hand, products authorized for emergency use pursuant to an Emergency Use Authorization (EUA) do need to have the entry information submitted to the FDA. During the time of the coronavirus pandemic, however, the FDA information is less than prior to the pandemic.
Goods that are authorized by the EUA include:
· Non-NIOSH-Approved Respirators: 80QKU
· NIOSH-Approved Respirators
· Face Masks (Non-Surgical)
· Diagnostic Tests Kits
· Face Shields
· Respirator Decontamination Systems
· Extracorporeal Blood Purification Devices
· Infusion Pumps
· Diaphragmatic Pacing Simulator Systems
The full text of the CSMS can be found here.
If you have any questions about your upcoming PPE or medical device import or want to ensure you are in compliance, contact experienced trade attorney David Hsu by phone/text at 832-896-62988 or by email at email@example.com.