This webinar will focus on the Health Innovation and Marketplace Technologies Act regulations that you need to know to get FDA approval for your mobile medical applications.  Join us as our panel of experts provide an in-depth outline of key timelines for a swift approval process.  A thorough outline of potential penalties and an analysis of the safety implications of these applications within patient communities will also be explained as we discuss the changing regulatory landscape.  This live webinar will also explain unforeseen effects of the Act on the medical mobile applications space and provide actionable steps to respond to those effects to stay ahead of the game.

This presentation will cover:

• An explanation of key guidance documents and classifications to help you determine if your app is regulated by the FDA
• A brief outline of the cost of submitting a 510(k) and of registering with the FDA
• An overview of guidance documents and the pre-submission process to help you determine if you need to submit a full application or if you can submit a 510(k)
• New regulations in the Healthcare Innovation and Marketplace Technologies Act that must be followed for quick FDA approval
• A clear explanation of timelines and penalties that effect expediency in the approval process
• Safety considerations in the development of a Medical Device application
• Systems requirements related to the development of a medical device application
• Unanticipated implications of the Act and how to address them before other developers to gain a competitive advantage

Who Should Attend:

• Chief Technology Officers
• Chief Compliance Officers
• Directors of Healthcare Integration
• Scientific Directors
• Medical Engineers
• Medical Mobile Application Developers
• Vice Presidents of Product Management
• Directors of Products