Overview
Explore the essentials of device law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about registration and listing procedures, elements of conducting clinical investigations, Premarket Approval Application, advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.
Speakers
Arun G. Rao
Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, U.S. Department of Justice
Lauren Roth
Associate Commissioner for Policy, Office of the Commissioner, FDA
Serena Viswanathan
Associate Director, Division of Advertising Practices, FTC
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