The FDA has opted to not appeal a federal court decision that struck down the agency’s rule to regulate laboratory-developed tests as medical devices.
The 60-day window for appeal has passed, effectively eliminating the rule that aimed to increase oversight of LDTs, according to a June 3 news release from the American Hospital Association.
Here are four more notes:
- On March 31, the U.S. District Court for the Eastern District of Texas ruled that the FDA lacked the statutory authority to regulate LDTs as medical devices. The decision sided with the American Clinical Laboratory Association and other plaintiffs who argued the agency overstepped its legal bounds with the rule.
- The FDA had finalized the rule April 29, 2024, and outlined a plan to phase in oversight of LDTs over four years. The tests, developed and used within individual laboratories, often in hospitals or academic medical centers, are increasingly used for cancer risk assessment, newborn screening, and diagnosing cardiac and neurological conditions.
- In fall 2023, the FDA issued a proposed rule which met immediate opposition from the American Hospital Association, which warned it could reduce patient access, hinder innovation and potentially drive up hospital costs. In finalizing the rule, the FDA said it had reviewed a large volume of public comments and made adjustments “in a manner that better serves public health.”
- Despite the revisions, legal opposition persisted and in May 2024, the ACLA filed a lawsuit against the FDA, alleging the agency lacked the authority to regulate the tests under its medical device framework.
