FDA National Evaluation System for health Technology (NEST)
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WHAT: Foundation to efficiently generate evidence for medical device evaluation and regulatory decision-making
WHY: National evaluation system would generate evidence across the total product lifecycle (TPLC), by leveraging real-world evidence (RWE)and applying advanced analytics
WHO: Link and synthesize data across the medical device landscape – clinical registries, electronic health records and medical billing claims
HOW: High quality RWE for health care providers and patients to make better informed treatment decisions; strike right balance between safety vs innovation and patient access
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