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- W1965784493 abstract "Patients need active regulatory oversight, linked to compulsory post-marketing researchAs therapeutic options, medical devices differ from prescription drugs in many ways, but one of the most important is their potential for rapid evolution in basic design or technology. In the context of prescription drugs, it would be completely unreasonable to take a basic chemical structure, add another methyl group to it, and presume the drug would work the same (or better) without subjecting the new molecule to additional clinical testing. Medical devices, by contrast, change often. In a study published earlier this year, we found that cardiac implantable electronic devices approved in the US had a median of 50 applications to the Food and Drug Administration (FDA) for big and small changes over their median 15 year regulatory lifespans.1In a linked paper (doi:10.1136/bmj.g5133), Nieuwenhuijse and colleagues provide important insights into the evidence base supporting new versions of hip and knee replacement devices.2 After conducting a systematic review of the literature and registry data, they found no good evidence of improved clinical outcomes for five widely used and marketed “advances” in hip and knee replacement technology, but they …" @default.
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- W1965784493 date "2014-09-09" @default.
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- W1965784493 title "Regulating incremental innovation in medical devices" @default.
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- W1965784493 doi "https://doi.org/10.1136/bmj.g5303" @default.
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