ACLA
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.
The proposed rule, which is likely to face industry challenges, calls for a four-year phase-in of LDT regulation while also suggesting possible carve-outs.