On 29 April 2024 local time, the FDA published its final rule regulating laboratory developed tests (LDTs). The rule clarifies that LDTs are in vitro diagnostic products, which are devices regulated under the Federal Food, Drug, and Cosmetic Act, including when the IVD manufacturer is a laboratory. In conjunction with the amendment, FDA finalised a policy that will provide greater oversight of IVDs supplied by LDTs through a general enforcement discretionary approach to phasing out LDTs over a four-year period. The phase-out policy consists of the following five phases:
Phase 1: Beginning 6 May 2025, 1 year after publication of the LDT final rule, FDA will expect compliance with Medical Device Reporting (MDR) requirements, Corrective and Removal Reporting (CRR) requirements, and Quality System (QS) requirements regarding complaint documentation.
Phase 2: Beginning on 6 May 2026, 2 years after the publication of the final LDT rule, FDA will expect compliance with requirements not covered in other phases of the phase-out policy, including registration and marketing requirements, labelling requirements, and clinical trial use requirements.
Stage 3: Beginning 6 May 2027, 3 years after publication of the final LDT rule, FDA will expect compliance with QS requirements (in addition to those already addressed in Stage 1 regarding complaint documentation).
Phase 4: Beginning on 6 November 2027, three and a half years after the publication of the LDT final rule, FDA will require that high-risk IVDs made available as LDTs comply with premarket review requirements. (IVDs may be classified as Class III or IVDs requiring licensure under Section 351 of the Public Health Service Act) unless a premarket submission has been received at the beginning of this phase, in which case FDA intends to continue to exercise its enforcement discretion to review the pending.
Phase 5: Beginning on 6 May 2028, four years after the publication of the LDT final rule, FDA will require compliance with premarket review requirements for intermediate- and low-risk IVDs offered as LDTs. (for which premarket submissions are required), unless a premarket submission has been received at the beginning of this phase, in which case FDA intends to continue to exercise its enforcement discretion in reviewing the pending.
In addition, the rule details certain categories of tests for which FDA will maintain its enforcement discretion policy.
FDA explains that its enforcement discretion policy no longer applies in light of the increasing complexity of LDTs and their prevalence in the healthcare system, including for the diagnosis and management of life-threatening conditions.FDA also notes that some vendors have begun to offer their tests as LDTs as a way of avoiding FDA’s regulatory oversight, even though these tests are marketed by a broad and diverse customer base, much like the traditional IVDs (in vitro diagnostic devices).” LDTs are being used more widely than ever before – for newborn screening, to help predict an individual’s risk of cancer, or to aid in the diagnosis of heart disease and Alzheimer’s disease,” FDA Administrator Robert Califf said in a statement following the release of the final rule. “The final rule announced today is intended to provide critically important regulation of these tests to help ensure that important medical decisions are made based on test results that patients and healthcare providers can trust.”
FDA’s purported efforts to regulate LDTs have been controversial in the clinical laboratory industry, with many opponents opposing the rule. Opponents have raised concerns that FDA regulation will hinder innovation and flexibility in laboratories, limit the development of test reagents, and ultimately harm patient care. Opponents also question whether FDA has the legal authority to regulate LDTs. legal challenges to the final rule on LDTs are widely expected.
