Review Finds Discrepancies Between Clearance Documentation and Marketing for Some ‘Smart’ Devices

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Review Finds Discrepancies Between Clearance Documentation and Marketing for Some ‘Smart’ Devices

J.W. Schomisch

July 20, 2023 at 09:31 AM EST

A systematic review of 119 FDA 510(k) clearance summaries and their respective marketing materials found “discrepancies between clearance documentation and marketing materials were present in one-fifth of devices surveyed.” “The aim of this study was not to suggest developers were creating and marketing unsafe or untrustworthy devices, but to show the need for study on the to... Read More

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Review Finds Discrepancies Between Clearance Documentation and Marketing for Some ‘Smart’ Devices

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