ACLA Files First Lawsuit Attempting to Block FDA’s Final Rule on LDTs

A clinical laboratory trade association and one of its member companies have filed suit against the FDA, asking the agency to overturn its final rule to regulate lab-developed tests (LDT) as medical devices claiming that the FDA doesn’t have the authority to scrutinize LDTs.

The first entities to sue the agency over the final rule, the American Clinical Laboratory Association (ACLA) and PCR lab HealthTrackRx, filed their lawsuit in the US District Court for the Eastern District of Texas on Wednesday seeking to block the rule.

The VALID Act, had Congress passed it, would have created a risk-based framework for IVCTs, requiring high-risk tests to go through premarket review while enabling lower-risk tests to go to market after passing a certification process. The FDA’s preamble to the final rule, which amends 21 CFR Part 809, also included details on a four-year phase out of the agency’s general enforcement discretion approach to LDTs. 

To read the whole story, click here.

Related Topics