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 revoked Emergency Use Authorizations for Non-NIOSH-Approved Disposable Respirators and Decontamination Systems, as access to FDA-authorized and NIOSH-approved N95s increases nationwide.
On June 30, 2021, the FDA announced the revocation of the following EUAs:
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)
As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings.
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.