Transition From COVID-19 Emergency: Demystify the FDA Requirements to Keep Your Device on The Market
On March 27, 2023, the FDA released its guidance Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to COVID-19. In this webinar, Dr. Jianlin Song of Wilson Elser Moskowitz Edelman & Dicker LLP and Dr. Christie Bergerson of Exponent review the latest guidance and discuss which groups of medical devices are impacted and the legal ramifications.
This webinar covers:
- What are the main groups of medical devices impacted?
- High level: How to go from EUA to traditional submission (EUA guidance doc).
- High level: Phased approach to traditional submission – non-EUA (Phased guidance doc).
- Legal ramifications: Overview and Prospective.
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 firstname.lastname@example.org 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.