
FDA Watch: 2022 510(k) Lab Test Approvals Year in Review
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
Diagnostic Testing and Emerging Technologies
LAB COMPLIANCE ADVISOR
LABORATORY INDUSTRY REPORT
NATIONAL LAB REPORTER
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.
The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of so-called Notified Bodies.