Wilson Sonsini Goodrich & Rosati is pleased to support the Bio2Device Group as it presents How to Secure an Emergency Use Authorization (EUA) for COVID-19. The EUA process can authorize the use of unapproved medical products or unapproved indications of approved products. Products like ventilators, in vitro diagnostics, and personal protective equipment that are submitted through the EUA process will be able to bypass the FDA clearance and approval process so that these products may be quickly available on the market. Shannon Clark, PE Founder & CEO of UserWise, Inc. will answer: What is an EUA? For what classifications of products can you pursue an EUA authorization? What is involved in obtaining an EUA for your product? What must you include in your EUA submission? How can you expedite the process for obtaining an EUA? How can you continue selling a product after the EUA expires? What are the guidance and regulations pertaining to EUAs?
Lori Doyle
ldoyle@wsgr.com