Overview
In vitro diagnostics (IVDs), tests conducted on samples taken from the human body, have been indispensable tools in combatting COVID-19. The industry is expected to grow significantly post-COVID-19, due in part to increased use of pandemic-necessitated innovations, such as remote collection and digital pathology. Currently, FDA’s necessary focus on COVID-19 has caused delays in review of IVDs not central to the pandemic response. This webinar will examine the essential role IVDs have played in addressing COVID-19, related compliance issues and enforcement trends, and how the virus-related shutdowns have led to the potential for exciting advancements in the ways IVDs are used. Speakers will also discuss strategies for working with FDA to facilitate review of diagnostics not related to COVID-19 response.
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Speakers
Toby Lowe, Associate Director, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA
Brad Spring, Vice President, Regulatory Affairs, Strategic Planning and Policy & US Regulatory Intelligence, BD
Randy J. Prebula, Partner, Hogan Lovells US LLP
Moderated by Allyson B. Mullen, Director, Hyman, Phelps & McNamara, PC and Co-Editor of Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment
ALLYSON B. MULLEN is a director at Hyman, Phelps & McNamara, P.C. where she provides counsel to medical device and in vitro diagnostic (IVD) manufacturers. Ms. Mullen assists clients with a wide range of pre- and postmarket regulatory topics, including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. In the premarket area, Ms. Mullen prepares IDEs, 510(k)s, de novos, and PMAs. She also prepares pre-submissions, breakthrough device designation requests, and assists clients in preparing for and represents clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, advertising and promotion, and QSR compliance. Ms. Mullen also helps clients with contract matters and regulatory due diligence. Prior to joining the firm in 2013, Ms. Mullen worked as in-house counsel at Waters Corporation, an IVD company. In this role, Ms. Mullen conducted a range of legal and regulatory functions.Virtual Learning FAQ
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