NES

WHAT:  To generate evidence across total product lifecycle by leveraging real-world evidence for medical device evaluation and regulatory decision-making

WHY:  Quality real-world evidence for health care providers and patients to make informed treatment decisions and balance safety vs device innovation and patient access

WHEN: Initial report in 2012. Included in CDRH 2016-2017 priorities

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tool2

WHAT: Web-based tool for developers of health-related mobile apps

WHO: Federal Trade Commission (FTC), Dept of  Health and Human Services, FDA

WHY: Help developers understand what federal laws and regulations  might apply to their apps – FTC Act, HIPAA, FD&C Act

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