ARUP Labs
In particular, new FDA requirements around modifying IVDs could lead labs to push for IVD vendors to validate their tests across a wider variety of use cases.
Labs and vendors are moving beyond traditional track-based systems to more modular, flexible robots that could, in some labs, eliminate human involvement altogether.
Despite Broad Carve-Outs, FDA Final Rule on LDTs Draws Critical Response From Lab Industry
The rule makes explicit that LDTs are subject to FDA oversight but provides for enforcement discretion across a broad range of tests.
Predetermined Change Control Plans (PCCPs) allow manufacturers to make certain updates to FDA-cleared devices without having to go back through premarket review.
Dissatisfaction with the soon-to-be released FDA rule on LDTs has prompted legislators to reconsider the VALID Act and other possibilities for LDT oversight.