July 6, 2021
The US Food and Drug Administration (FDA) has closed coronavirus pandemic-related emergency market access routes for some disposable respirator devices and personal protective equipment (PPE) as domestic supplies of these products stabilize.
According to the agency’s updated Emergency Use Authorization (EUA) page, EUAs for the products listed below are now effectively revoked:
- Imported disposable filtering facepiece respirators lacking approval from the US National Institute for Occupational Safety and Health (NIOSH)
- Non-NIOSH-approved disposable filtering facepiece respirators imported from China
- Decontamination and bioburden reduction systems for PPE
Revocation of these EUAs means FDA no longer authorizes US healthcare personnel to use these products in healthcare settings, and follow recommendations issued by the agency in May that healthcare providers transition away from using these products.
In a letter to healthcare providers dated June 30, FDA recommended that healthcare personnel begin using N95 and other respirators that have either been cleared by the agency or received NIOSH approval. FDA also recommended that healthcare personnel rely on “conventional capacity strategies” reflecting improved access to PPE supplies.
Going forward, manufacturers of PPE affected by FDA’s latest round of EUA revocations should consider conventional market access pathways in order to commercialize in the US.
What to do with non-NIOSH-approved PPE?
Healthcare providers with PPE inventories that still include products whose EUAs have been revoked should consider redistributing such equipment to construction and other non-healthcare settings, or to other countries with greater need for PPE to deal with COVID-19 outbreaks.
The FDA letter also advised healthcare providers to increase their inventories of NIOSH-approved respirators such as N95 disposable filtering facepiece respirators (FFR), elastometric respirators and powered air-purifying respirators (PAPR).
The letter notes, however, that several other categories of PPE remain on FDA’s medical device shortage list due to the COVID-19 public health emergency, including surgical respirators, gloves and surgical apparel.
Learn more about US FDA medical device regulations and EUA requirements at Emergo by UL:
- FDA 510(k) consulting for medical device and IVD companies