A federal judge in Texas has ruled that the FDA does not have the authority to regulate laboratory developed tests as medical devices, striking down the agency’s recently finalized rule.
The decision, issued in the U.S. District Court for the Eastern District of Texas, sided with the American Clinical Laboratory Association and other plaintiffs who argued that the FDA overstepped its authority, according to documents reviewed by Becker’s.
The FDA finalized its rule in April, aiming to phase in oversight for laboratory-developed devices over four years, with then-FDA Commissioner Robert Califf, MD, citing the increasing use of the tests for areas such as newborn screening, cancer risk assessment and diagnoses for other critical conditions.
However, the ACLA and other industry groups opposed the move, saying it could stifle innovation, limit patient access and increase costs.
As a result, the ACLA filed a lawsuit against the FDA in May, alleging that the agency lacked the authority to regulate laboratory developed tests under its medical device framework. The American Hospital Association also opposed the rule, saying the decision to impose the medical device regulations on the laboratory developed tests could increase hospital costs.
