The U.S. Food and Drug Administration (FDA) has now rescinded 2024 rules that required laboratory-developed tests (LTDs) to comply with the agency’s pre-marketing authorization requirements applicable to medical devices.
Under the scope of the 2024 rules, the FDA revised its existing pre-market authorization requirements to include LTDs. The revised rules required that hospitals and healthcare systems that develop their own LDTs for use in-house seek FDA authorization prior to their use.
However, LTDs are generally not commercially distributed and are used exclusively in healthcare settings to provide accurate, high-quality results that give physicians timely and critical information to diagnose and treat patients.
From the outset, the 2024 rule changes faced pushback from many healthcare organizations, including the U.S. American Hospital Association (AHA), that claimed the FDA’s action represented an overreach of its authority. That view was ultimately validated in a federal court decision earlier this year that vacated the FDA’s 2024 rule revisions.
The Final Rule issued by the FDA rescinding its 2024 rule changes is available at https://www.federalregister.gov/documents/2025/09/19/2025-18239/regulation-identification-number-0910-aj05-medical-devices-laboratory-developed-tests-implementation.
