Investor Presentaiton

v0.1 April 2018 v0.2 June 2018 • IMDRF International Medical Device Regulators Forum DIGITAL HEALTH PRECERTIFICATION WORKING MODEL Content Highlights Program outline & abstract . • Excellence appraisal and certification level • Review pathway determination • • Streamlined premarket review and • Real world performance (RWP) • Challenge questions for public input • Detail on precertification program process and components: • Proposed appraisal criteria • Proposed review pathway determination leveraging IMDRF framework • . Proposed possible premarket review elements and • Proposed elements of post market RWP analytics • Feedback Strong support for shift in regulatory paradigm to address digital health technologies • Public seeking greater clarity on: • • Vision, goals and objectives of the program • Scope and eligibility and • How program components intersect Recommendations include: • Easing into the program using a continuous learning process to ensure program success, improving outcomes, and productivity • Adequately ensuring the safety and effectiveness of specific SaMD submissions via a combination of streamlined review and RWP and Balancing desire to tailor the program to individual companies with a framework that is predictable for potential participants and minimizes complexity 5

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