IVDR - G2 Intelligence

The Top 10 Most Significant FDA New Lab Test Approvals of 2022

Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.

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A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.

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The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of so-called Notified Bodies.

While the much-delayed IVDR will take effect at the end of the month, it will be rolled out gradually.