FDA and Medical Device Emergency Use Authorization (EUA)

In January 2017, FDA issued a guidance document regarding issuance of EUAs during declared public health emergencies. This guidance provides general information on when EUAs are applicable, and how they are issued. It also explains general recommendations in response to the FD&C Act “Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.” In the past, additional and specific guidance documents from FDA have been issued for potential and actual emergencies, such as Bird Flu, Swine Flu, Ebola, and Zika.

Currently, the COVID-19 pandemic has resulted in issuance of several specific guidance documents and a number EUAs for Personal Protective Equipment (PPE), In Vitro Diagnostics (IVDs), Ventilators, and other medical devices. On February 4, 2020, the Secretary of the Health and Human Services (HHS) determined a potential for this virus to present a public health emergency. As we have seen, a number of EUAs have been issued for PPE, IVDs, testing laboratories, ventilators, respiratory devices, and blood purification devices.

Because the situation changes daily, and new EUAs are issued regularly, the content of this presentation will necessarily be updated up to the time it is delivered. We will also offer some insights on preparedness for future public health emergencies, as this is key to quickly responding when one is declared.

Linda Chatwin has been involved with regulated medical products for over 35 years. Her expertise includes navigating the global regulatory maze required to bring products to market, achieved through years of watching regulations evolve and change. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. Linda has navigated many FDA inspections, and has negotiated favorable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including MDD/MDR training, transition and implementation, quality system structure and implementation, UDI processes, performing mock audits, in-depth training on various regulatory requirements and consulting on a variety of regulatory issues. 

This webinar was recorded on June 4, 2020.