USA – FDA proposes down-classifying most high-risk IVDs

The US Food and Drug Administration (FDA) intends to reclassify most high-risk in-vitro diagnostics (IVDs) from class III devices to class II moderate-risk devices. The agency says the move will ease the burden on IVD sponsors who can use the 510(k) premarket notification pathway instead of the more burdensome premarket approval (PMA) process.

Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), announced the proposal in a statement on 31 January, in which he also stated that most of the affected tests are for infectious disease and companion diagnostic IVDs.

“CDRH would still be conducting a premarket review of reclassified tests under the 510(k) pathway,” he added. “Such reclassifications may support the potential for more manufacturers to develop these tests, which can increase competition and increase access to these important tests.”…