Event Information

Event Topic:
How to Secure an Emergency Use Authorization (EUA) for COVID-19

Event Description:
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. Learn about • 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?

Date/Time:
Date(s) - 04/28/20
8:30 am - 10:00 am

Event Location:
Other: Webinar

Speaker Information

Event Speaker:
Shannon Clark, PE

Event Speaker Title:
Founder & CEO

Event Speaker Company:
UserWise, Inc

Event Speaker Bio:

Shannon has more than 10 years of experience in medical device and combination product human factors engineering, design, risk management, V&V, CAD modeling, training program development, marketing, compliance, and auditing quality systems. Shannon currently sits on the IEC Standards Committee and is actively involved in developing and refining international human factors standards and has led training seminars at the FDA. Shannon is the co-lead investigator on the FDA (CDER) Training Decay grant with UserWise and San Jose State University. At UserWise, she works with medical device and combination product companies to develop strategy and answer regulator questions for human factors submissions domestically and globally and regularly participates on projects as a subject matter expert.

Event Details

Cost:
$0

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