FDA Requirements in the Age of COVID-19

The Food and Drug Administration is the main regulatory body overseeing the production and distribution of PPE in the United States. The level of FDA involvement depends on the class of the device, which can range from class 1 to class 3 based on the device’s potential risk of nonconformance. Most types of PPE are labeled as class 1 devices, which have the fewest barriers to approval.

Because it can take months or even years to gain FDA approval, in times of health crisis the FDA issues something called an Emergency Use Authorization (EUA). An EUA essentially loosens the requirements for production and distribution of certain medical products to allow production to ramp up quickly. EUAs are currently being granted to manufacturers of COVID test kits, virus therapies, ventilators, respirators, and PPE. These emergency authorizations are generally granted to specific companies who apply to expedite the approval process, but they are also being released as blanket statements covering certain types of PPE so that smaller companies can also participate with minimal red tape. The EUAs include additional documentation that outline the enforcement policy for PPE manufacturing during the current public health emergency and provides criteria for quality control standards as well as the required labeling of products released under the authorization.