Bradley Merrill Thompson, Member of the Firm, will copresent “Bridging the Digital Innovation and Regulatory Divide: Bringing Mobile Apps to Market in a Compliant and Timely Manner” at Legal and Business Guide to mHealth and Wireless Medical Technology.
Many application developers are struggling to reconcile their business goals with the regulatory oversight affecting medical devices. This panel will forecast the front-runners in the race to develop the hottest new health application in light of the evolution of the FDA’s treatment of mobile health applications. It will then examine how companies are balancing the FDA’s initial regulatory guidance and the first set of clearances issued to this exciting field of products to provide practical guidance on:
- Industry overview: what products have experienced sustained growth?
- wellness; lifestyle; diagnostic
- Where is the industry heading?
- medication dispensing
- use of algorithms to diagnose
- Understanding what applications need FDA approval
- Establishing a predicate device for a novel mobile medical app
- Analyzing how software is regulated by the FDA
- when registration as a mHealth supplier is necessary
- Advice on working with the FDA from companies that have successfully gained clearance
For more information, visit AmericanConference.com.