Augmented reality (AR) is a novel technology that has various applications across the healthcare industry from training and education, pre-operative planning, and intra-operative use. As this technology continues to evolve and the medical device industry develops systems utilizing AR, regulators and industry must work together to educate one another to enable introduction of AR into the marketplace. This session will engage medical device professionals looking to understand the regulatory challenges of novel technology (such as AR), providing insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel technology while engaging the FDA in the effort. This session will discuss regulatory considerations for novel technology such as human factors considerations, and proper terminology for communicating these devices to regulators. Participants will walk away with a better understanding on how to formulate regulatory strategies for novel devices and how to communicate this new technology to regulators.
Learning Objectives:
Describe actual and future AR applications that are changing patient treatment and healthcare delivery through the exploration of real-world examples (across different diagnostic/therapeutic and technology areas).
Demonstrate knowledge of US perspectives on current developments and challenges stemming from the development and implementation of AR in development of regulatory strategies.
Develop and execute regulatory strategies that meet real-world needs posed by AR.