EUAs, 510(k)s and De Novos Demystified: Bringing COVID-19 Tests to the US Market

September 21, 2022

COVID-19 test developers and regulatory bodies rose to the challenge of quickly supplying the public with the tests necessary to determine infection status. However, many of these tests were brought to market via a regulatory pathway dependent on the COVID-19 public health emergency declaration. What happens to these tests once the public health emergency declaration expires?

In this webinar, viewers can expect to learn:
• The differences between the FDA pathways to market
• A basic primer on how in vitro diagnostic tests work
• The regulatory landscape surrounding COVID-19 tests
• The legal implications surrounding COVID-19 tests, including PREP Act involvement and sale under EUA

Dr. Christie Bergerson | Manager | Exponent

Dr. Bergerson consults with companies in the in vitro diagnostics space. Recent projects include developing next-generation assays, analyzers and commodities, including the hardware, software and firmware. Her support extends through the preparation of software and diagnostic-related documentation in accordance with QSR requirements, ranging from risk management documents to verification and validation protocols and test reports and assistance with regulatory submissions per the FDA, CE-IVDR and WHO guidelines. You can learn more about Dr. Bergerson via her Exponent and LinkedIn profiles, email her at cbergerson@exponent.com or call her at (682) 367-6973.

Dr. Jianlin Song | Partner | Wilson Elser

Dr. Song, MD, JD, is a Partner in the Life Science Litigation Group at Wilson Elser Moskowitz Edelman and Dicker LLP’s San Francisco office. During her 15 years of legal practice, Dr. Song has defended manufacturers of a broad spectrum of life science products, from food supplements and dental adhesives to prescription drugs and Class II medical devices such as joint replacements, electroconvulsive therapy devices and cold therapy devices. She has also defended diagnostic laboratories, fertility centers, and various medical, dental and psychiatric professionals in malpractice cases. Among her many successes, Dr. Song won a motion for summary judgment for the manufacturer of a 3D-printed joint prosthesis in what was likely the first products liability case against a 3D device in California. In addition to litigation, Dr. Song counsels small businesses, both domestic and international, on pre- and post-marketing compliance issues. She has helped companies from various parts of Asia bring hand sanitizers and other PPEs onto the United States market during the COVID-19 pandemic.