FDA's Oversight of Mobile Medical Applications (''apps'') for Use on Smartphones and Similar Mobile Devices

This 90-minute webinar is designed to provide attendees with an overview of the U.S. Food and Drug Administration's oversight of certain medical and healthcare mobile medical applications ("apps") designed for use on smartphones and other mobile computing devices. You will learn to distinguish between those apps requiring FDA review and those not subject to regulatory oversight.

Who Will Benefit:

• Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Policy Officials, Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists.
• Medical device and Biotech Companies, Start-ups, Foreign Device Manufacturers, Importers, Device Reprocessors; Mobile and Smartphone Companies; the Telecom Industry
• Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries

Instructor Profile:

Karl Nobert, is a regulatory attorney with the law firm of Squire Sanders in Washington, DC. He provides regulatory advice and counseling to domestic and international medical device manufacturers and biotech companies on issues related to the U.S. Food and Drug Administration’s regulation of medical devices including mobile medical app and portable devices. He regulatory assists clients with determining the regulatory status of a proposed medical device, and has companies with the development of strategies for the marketing of Class I – Class III medical devices. This has included assisting with the preparation of 510(k) submissions and Premarket Approval packets. He frequently presents and has published on such topics.