As health care providers continue to increasingly depend on telemedicine to deliver care to a broader population and to reduce the overall cost of its delivery, legal and regulatory questions remain. Devices and mobile medical applications that enable the delivery of telemedicine services are subject to a complex web of regulations by multiple federal agencies, including the Food and Drug Administration (FDA), the Federal Communications Commission (FCC), and the Federal Trade Commission (FTC). Of all of these agencies, the FDA has been particularly active in its promulgation of policies for this slice of the industry - most recently issuing draft guidance in August 2016 on device modification policy. But the challenge for manufacturers of mobile medical apps and devices remains -- understanding how to navigate the process of categorizing your device and state its "intended use" to the agency. This session will help attendees understand how to approach this process, the remaining questions/gaps in the FDA guidance and how to manage them, and importance of recognizing the FDA as a partner throughout the lifecycle of the devices it regulates.
- Understand the process of categorizing a mobile medical app or product and the importance of “intended use.”
- Grasp the existing FDA guidance, current gaps in policy, and how to manage them
- Appreciate the critical relationship that exists between a company and the FDA that regulates its devices, and learn tips to appropriately nurture it