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# Lab Groups Seek Summary Judgment in LDT Suit
- URL: https://www.fdaweb.com/lab-groups-seek-summary-judgment-in-ldt-suit/
- Published: 2024-10-02T12:00:00.000Z
- Updated: 2026-09-14T14:42:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157904

The Association for Molecular Pathology (AMP) and the American Clinical Laboratories Association have asked a Texas federal court for summary judgment against FDA in their suit challenging the agency’s final rule that asserts authority to regulate laboratory-developed tests (LDTs). The [motion](http://www.fdaweb.com/download.php?file=motion%5FLDT%5F9-2024.pdf) reiterates the associations’ [arguments](https://www.fdaweb.com/ldt-power-grab-suit-filed-against-fda/) against the FDA final rule, claiming that Congress never authorized the agency to regulate LDTs.

It argues that if the final rule takes effect, there will be “disastrous results for plaintiffs and patients alike.” The AMP says that given the risk of prosecution and the high cost of complying with the rule, many of its members have suspended work on new LDTs that could be used to help diagnose serious diseases and inform treatment options. Smaller labs will be forced out of business, it says, and there will be job losses among pathologists.

“It is imperative that this court act to prevent the catastrophic consequences that FDA’s patently unlawful final rule will unleash,” the petition says. Noting that agencies only have powers given to them by Congress, the associations say “that principle carries added force in cases like this one, where an agency seeks to impose vast new regulatory mandates by belatedly seeking power under decades-old legislation, especially when, as here, Congress repeatedly has considered, and repeatedly declined to grant, the asserted powers in the interim…. FDA’s rejection of these principles cannot stand. Like everyone else, the agency is free to express disagreement with Congress’ choices and continue lobbying Congress for the regulatory authority it craves. But it cannot lawfully seize power by the stroke of its own pen, and its violation of these fundamental precepts of administrative law cries out for judicial intervention. The final rule should be vacated and defendants promptly enjoined from taking any action to enforce it.”