Article | December 3, 2024

Navigating Uncertainty With The FDA LDT Rule

Source: ProPharma

By Tina Hudson, Senior Director, Diagnostics and Combination Products

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On May 6, 2024, the FDA issued its Final Rule on the regulation of Laboratory Developed Tests (LDTs), initiating a four-year phaseout of its previous enforcement discretion. This rule impacts in vitro diagnostics (IVDs) developed under CLIA-certified laboratories, asserting FDA's authority over LDTs as medical devices.

The phaseout is divided into five stages, with Stage 1 compliance requirements, such as medical device reporting and quality system updates, set for May 6, 2025. However, the rule faces legal challenges from organizations like the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), questioning FDA’s regulatory authority. While some industry groups advocate for continued CLIA oversight, the regulatory landscape remains contentious, with divided political and industry responses.

To prepare, labs should assess product classification, identify quality system gaps, and develop regulatory strategies aligned with phaseout timelines. Key steps include clinical data review, performance validation, and training on FDA requirements. Partnering with experts, such as ProPharma, can help laboratories navigate the transition, ensuring compliance while maintaining operations amidst evolving regulations.

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