Data collected from electronic health records, registries and wearable technology can be valuable sources of “real-world” data and evidence—just as valid as clinical trials—in helping the Food and Drug Administration to make regulatory decisions about the safety and effectiveness of medical devices.
That’s the contention of Health IT Now, a coalition of providers, patient advocates, consumers and payers, which provided written comments to the FDA regarding its draft guidance entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.
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