COVID-19 lead to a global health crisis, imposing the greatest challenges for medical communities. The threatening patterns of pandemic transmission and rapid rate of contagion invoked an emergency need of diagnostic kits, Personal Protective Equipment (PPE), ventilators, etc., in the United States. Hence, there is a pressing demand to fulfil the device shortages at the earliest, by maintaining the required safety and quality standards.
In the public health emergencies, the United States Food and Drug Administration (US FDA) issues EUAs (Emergency Use Authorizations) for certain categories of products. In general, the EUA is subjected to the statutory limits tied to the end of public health emergencies and will remain effective only for the duration of EUA declaration, under which it was issued. Hence, manufacturers are suggested to develop their product for the Agency’s approval even after the termination of the emergency and evaluate the product’s better fit for the EUA or expanded use, under enforcement discretion by the FDA.
To meet the medical emergencies during the current pandemic, the US FDA has enforced EUAs (Emergency Use Authorizations) for certain categories of medical devices. For successful compliance and quick market-entry at this time of need, device manufacturers are first required to understand how the US FDA defines EUAs. In addition, they should decode various device categories that qualify for EUA, the procedure that the EUA contain, post EUA Regulatory requirements for continued marketing of these category devices in the US, etc.