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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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