FDA recently issued an array of COVID-19- related guidance documents that facilitate expanded availability of certain medical products during the current public health emergency through enforcement discretion and other temporary policies. These products include diagnostics, personal protective equipment, remote monitoring devices, ventilators, disinfectant devices, clinical electronic thermometers, and hand sanitizers. This webinar will examine the scope of these guidances, their impact on regulated companies, and how they relate to other FDA requirements, such as Emergency Use Authorizations.
Hannah Bornstein, Partner, Nixon Peabody LLP
Carmine Jabri , President, E.M.M.A. International Consulting Group, Inc
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Gregory H. Levine, Partner, Ropes & Gray LLP