FDA Regulationsfor Emergency Use Authorization (EUA)of Medical Devices & PPE

U.S. FDA created the fast-track procedure called Emergency Use Authorization (EUA) to meet the surge in demand for the desperately needed Personal Protective Equipment (PPE), such as masks, N95 respirators, infrared thermometers, ventilators, patient examination and surgical gloves, and other infection control/prevention PPEsor invitro diagnostic product to respond to thenational COVID-19 Emergency.

Our FDA 510(k) Consultants specializes in assisting our medical device industry to navigate the FDA’s fast changing regulatory landscape to fast track the medical products and make it available to consumers and health care professionals nationwide. Our FDA 510(k) Consultantsare ready to help our industry partners to meet the global challenge in navigating FDA’s fast changing regulatory requirements to bring your medical products quickly to the U.S. market through EUA pathway.