What do the different regulatory statuses mean for various PPE products?
The US Center for Disease Control (CDC) National Institute for Occupational Safety and Health (NIOSH) regulates respirators (N95 masks) for occupational health. NIOSH maintains an extensive list of approved N95 respirators. These were not intended for medical use, but are appropriate for hospitals under the emergency circumstances brought on by the COVID-19 pandemic, hence these respirators will not be found on the FDA Establishment Registration & Device Listing database.
FDA 510(k) Cleared
The US Food and Drug Administration (FDA) requires manufacturers of certain classes of products to submit a technical dossier to demonstrate that the device is "substantially equivalent" to a predicate device (i.e. a product already cleared for sale in the US). The FDA reviews the 510(k) submission and "clears" the specific device. Certain classes of medical devices require such clearance before they can be legally distributed in the United States. Products on the supplier list with a regulatory status of FDA 510(k) Cleared are listed in the FDA Premarket notification database.
FDA EUA List
During the COVID-19 crisis, the FDA has issued Emergency Use Authorizations (EUAs) that waive certain regulatory requirements and specifically authorize the importation and distribution of specific items listed in the EUA for the uses described in the EUA, so long as the importation, distribution or use of such items falls within the scope of authorization in the EUA. To be cleared under an EUA, manufacturers or importers submit a document package to FDA and if the device meets FDA’s criteria, the FDA will list the EUA-cleared product by name or category. The FDA has issued EUAs which authorize specific ventilators , in vitro diagnostics and other products for the duration of the COVID-19 Public Health Emergency.
FDA EUA Criteria
During the COVID-19 crisis, the FDA has issued Emergency Use Authorizations (EUA) for certain PPE and other products used by healthcare workers. These EUAs list specific product criteria and labeling requirements the product must meet and also indicate which of the usual regulatory requirements are waived for the duration of the COVID-19 PHE. The FDA has issued a specific EUA for Face Shields.
FDA No Objection/Exercise of Enforcement Discretion
FDA recognizes that, when alternatives, such as FDA-cleared masks or respirators, are unavailable, individuals, including healthcare professionals, might improvise PPE. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available. FDA has issued Enforcement Policy guidelines where it sets out the conditions under which the agency will not object to the importation or use of products that meet specific criteria and for which specified regulatory requirements have been waived. Recently, FDA issued a revised FDA Enforcement Policy Face Masks and Respirators