What you should consider when importing PPE
Personal Protective Equipment (PPE)
Under the EUA (Emergency Use Authorization), the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea, and Mexico who have similar standards to NIOSH (National Institute for Occupational Safety and Health).
When evaluating whether these products are intended for a medical purpose, among other considerations, FDA will consider whether:
■ they are labeled or otherwise intended for use by a HCP (Health Care Professional)
■ they are labeled or otherwise for use in a health care facility or environment
■ they include any drugs, biologics, or anti-microbial/anti-viral agents.
Face masks, face shields, and N95 respirators are medical devices, when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.
FDA issued a new EUA for non-NIOSH-approved N95 respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator meets certain standards.
Before you send your purchase order
■ Determine whether the manufacturer is registered with the FDA, and has a DUNS Number.
■ Ask the manufacturer to provide Owner / Operator Number.
■ Request the Listing Number for each product.
■ Make sure you have your company’s Employer Identification Number (EIN) and DUNS Number.
Then, contact ITB HOLDINGS LLC to register your company as Medical Device Establishment.