FDA's Oversight of Mobile Medical Applications ('apps') for Use on Smartphones and Similar Mobile Devices 2013

Key Topics

• The criteria for distinguishing between regulated and unregulated mobile medical apps
• FDA’s regulation of mobile medical apps
• The July 2011 Mobile Medical App Draft Guidance Document
• Discussion of the responsibilities of a regulated entity
• Identification of application FDA regulations, guidance documents and other relevant documents
• What regulatory requirements must a manufacture comply with to market a regulated app

Who should Attend

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