AUTHOR: Reynaldo Roman | Director, Regulatory Compliance
In an effort to facilitate the import and supply of PPE into the US, both Customs (CBP) and the FDA have provided guidance on the types of PPE that may be imported.
To combat PPE shortages, the FDA has invoked its Emergency Use Authorization (EUA) authority to lift some of the restrictions that apply to the import of certain PPEs.
PPEs that may be imported to the US include, but are not limited to:
- Personal protective equipment for general purpose or industrial use (e.g., products that are not intended for use to prevent disease or illness).
- Pediatric/Child Facemasks
- Surgical Masks with antimicrobial/antiviral agent
- Surgical Respirators
- N95 Respirator with Antimicrobial/Antiviral Agent
- Surgical Apparel Accessory (Face Shields)
- NIOSH Approved Filtering Facepiece Respirators (including N95s) under EUA
- NIOSH Approved FFRs including N95s under EUA
- KN95, KN100, KP100, and KP95 Filtering Facepiece Respirators (Standard GB 2626-2006) NOT Under EUA
- Non-NIOSH Filtering Facepiece Respirators under EUA
Please note that while Customs and FDA are simplifying the import of PPEs, imported products must still be cleared by the agencies upon arrival to the US. Customs and FDA import documents and data must always be accurate and complete to avoid clearance delays.
CBP has created a COVID-19 Relief web page with links to FAQs and other resources to help importers with their PPE related shipments.