ACLA
Federal Court Vacates FDA Rule on Laboratory-Developed Tests
The ruling prevents the FDA rule on LDTs, which is opposed by much of the clinical lab industry and many segments of the broader healthcare industry, from going into effect.
The rule could force labs to shed tests deemed nonessential to their institutions' missions as well as influence decisions around instrumentation and vendor choices.
ACLA Sues FDA Over Laboratory-Developed Test Final Rule
In the suit, filed in the US District Court for the Eastern District of Texas, ACLA requested the court enter a declaratory judgment that FDA cannot legally regulate LDTs.
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.
Medicare contractors want to rein in inappropriate use of genetics tests, but lab and pathologist groups worry that new coverage requirements may limit access.