ACLA
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.
FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests
The rule, which would make explicit FDA's authority to regulate LDTs, is certain to face pushback from many in the laboratory and diagnostics industries.
The projects signal ongoing concern among health regulators about the quality and regulation of lab-developed tests used to guide cancer treatment and gauge disease risk.
FDA, HHS Update COVID-19 Test Emergency Use Authorization Policies
The FDA said it intends to focus on specific EUA requests, while HHS withdrew a policy directing FDA not to enforce premarket review requirements for LDTs.