Hospital & Healthcare Management March 7, 2024
It is worth noting that the US Food and Drug Administration- FDA has recently gone on to highlight the data integrity issues that concern the premarket submissions received in case of medical devices.
The agency has gone on to declare that it has identified a surge in terms of fraudulent as well as unreliable laboratory testing data within such submissions.
It has gone ahead and advised manufacturers, along with the study sponsors, for these products to make sure to carefully gauge the third parties they happen to engage with so as to conduct performance testing and to independently double-check all testing results prior to submitting them to the FDA.
Making sure of the data integrity of medical devices
The FDA...
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