Investor Presentaiton
IMDRF
International Medical
Device Regulators Forum
DIGITAL HEALTH:
FDA PRECERTIFICATION PROGRAM GOALS
1. Enable a modern and efficient regulatory framework that allows
software iterations and changes to occur in a timely fashion
2. Develop a tailored and pragmatic regulatory oversight that trusts
organizations with a demonstrated culture of quality and organizational
excellence to develop high quality, safe and effective software products
3. Leverage transparency regarding an organization's product
performance across the entire lifecycle of SaMD
4. Use a tailored streamlined premarket review and leverage unique
postmarket opportunities available in software to verify the continued
safety, effectiveness, and performance of SaMD in the real world
5. Be a program that learns and adapts (i.e., adjusts/tweaks/evolves
scorecard elements and key dimensions and measures) and can adjust
key elements and measures based on the effectiveness of the programⓇ
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