Devices

Labs Ask Court to Throw Out FDA’s LDT Rule

David McFarland

— 1 min read
Share

In a new motion, the American Clinical Laboratory Association, HealthTrackRx Indiana, and HealthTrackRx, Inc., are asking a Texas federal court to grant summary judgment in favor of their 5/29 suit against FDA and vacate the FDA 5/4 final rule asserting oversight over laboratory-developed tests. In their latest court filing, the plaintiffs ask the court to resolve this question: Does FDA have statutory authority to upend decades of settled practice by regulating professional laboratory testing services as if they are unapproved medical devices under the Federal Food, Drug, and Cosmetic Act?

The filing lists these three points the plaintiffs say make clear that the FDA rule exceeds the agency’s authority and is arbitrary and capricious in violation of the Administrative Procedure Act:

  • FDA faces a heavy burden to justify its extraordinary position;
  • FDA cannot meet its heavy burden to justify the new rule because Congress has never granted FDA authority to regulate professional laboratory services as manufactured medical devices, let alone do so with a clear statement; and
  • FDA’s attempts to mitigate the effects of its sweeping power grab only confirm that its position is untenable.

Read more