Affected laboratories, hospitals, practitioners, and medical device makers should start preparing now for compliance with new FDA regulations for laboratory developed tests (LDTs). The FDA in May announced its rule regulating LDTs, which historically were not required to meet the same compliance standards as other medical devices under the FDA’s previous policy of “enforcement discretion.” The final rule redefines in vitro diagnostic products (IVDs) to include LDTs manufactured and offered by laboratories as medical devices.
A complaint filed in late May by the American Clinical Laboratory Association (ACLA) and HealthTrackRx contests the FDA’s authority, arguing it violated the Administrative Procedure Act by attempting to regulate LDTs, which are described as “professional services performed by professional clinicians in a laboratory” rather than “tangible, physical objects.” This case, American Clinical Laboratory Association v. U.S. Food and Drug Administration (E.D. Tex., Docket No. 4:24-cv-00479), was filed just before the US Supreme Court’s decisions reducing courts’ deference to agency interpretations of ambiguous statutes.
Despite the pending litigation, the final rule remains in force, and industry stakeholders should not delay preparations. The FDA will phase out its enforcement discretion approach over five stages within four years. The first stage, beginning May 6, 2025, mandates laboratories to comply with medical device reporting requirements, correction and removal reporting requirements, and complaint handling requirements.
Laboratories should map out deadlines and resources needed for compliance and take a detailed inventory of their tests. Certain types of tests may still benefit from targeted enforcement discretion policies based on factors such as intended uses, intended users, and marketing dates. The FDA has provided guidance on these matters, including specific advice on compliance with new quality system regulations, which will align more closely with International Organization for Standardization requirements by February 2, 2026.
Considering these developments, laboratories and associated stakeholders should begin aligning their operations with these regulations to avoid future compliance complications. While the outcome of the litigation remains uncertain, proactive measures now will help mitigate potential disruptions.
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