Laboratory Consulting Services
FDA Lab Consulting Services: LDTs
On May 6, 2024, FDA issued a new rule amending the regulatory definition of in vitro diagnostic (IVD) device to include laboratory-developed tests (LDTs) and ending the agency’s longstanding policy of generalized enforcement discretion.
Lighthouse Lab Services can help you develop a customized strategy to meet the new FDA final rule and continue using your laboratory-developed tests to benefit your patients. Please explore our website or contact us directly to learn more.
FDA’s Final Rule for LDTs: Overview
On May 6, 2024, FDA issued a new rule amending the regulatory definition of in vitro diagnostic (IVD) device to include laboratory-developed tests (LDTs) and ending the agency’s longstanding policy of generalized enforcement discretion. This means that LDTs will be regulated as medical devices and clinical laboratories that develop, validate, and perform them will be regulated as medical device manufacturers.
FDA plans to phase out generalized enforcement discretion and phase in pre- and post-market requirements for LDTs over the next four years. Some LDTs will be subject to premarket authorization requirements (510(k), De Novo classification, or premarket approval (PMA). Some categories of LDTs will continue to be eligible for enforcement discretion with respect to some or all of these requirements. FDA’s new requirements foreseeably will result in significant operational changes and increased laboratory costs.
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Expert Guidance: Our scientists and regulatory experts are at the forefront of breaking news.
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Concerned About How This Shift Could Impact Your Lab?
We can help you develop a customized strategy to meet the new FDA final rule using your laboratory-developed tests to benefit your patients. Please reach out to us directly to learn more. Schedule a Free ConsultationAppendix: Detailed Terms and Timelines
What is an LDT?
The final rule describes an LDT as a test that is designed, manufactured, and used within a single laboratory, although FDA acknowledges that many tests offered as LDTs do not fit this narrow definition (e.g., some laboratories perform testing at multiple locations).
Table 1 - Phaseout Timeline (Stages 1 and 2):
Stage | Effective Date | Requirements to be met unless otherwise exempt |
Stage 1 | May 6, 2025 | Labs must have procedures in place to comply with the following: - Medical Device Reporting (21 C.F.R. Part 803) |
Stage 2 | May 6, 2026 | Labs must register their establishment (i.e., facility) with FDA and list each individual LDT (21 C.F.R. Part 807) LDTs much comply with FDA labeling requirements (e.g., 21 C.F.R. Part 801 and 809) Labs conducting LDTs for clinical investigations must comply with applicable investigational device requirements (e.g., 21 C.F.R. Part 812) |
Table 2 - Targeted Categories of Enforcement Discretion:
No Premarket Review or QSR (except records) | No Premarket Review | Full Enforcement Discretion | No Enforcement Discretion |
LDTs that were marketed prior to May 6, 2024 and that are not modified/modified in limited ways | Tests approved by NYS’s Clinical Laboratory Evaluation Program | 1976-Type LDTs (no automation, FDA authorized components, designed, manufactured, and used within a single high-complexity CLIA lab) | DTC LDTs (offered directly to consumers without an HCP intermediary) |
Tests manufactured and performed by a lab integrated with a healthcare system to meet an unmet need | Certain HLA tests | Certain donor screening LDTs are required for the determination of blood group and Rh factors | |
Certain non-molecular antisera LDTs for rare red blood cell antigens | Forensic Use Only tests-80364 | Tests intended to address emergencies or material threats (e.g., a pandemic) | |
LDTs manufactured and performed within DoD or VHA |
FAQs
What is Enforcement Discretion?
Enforcement discretion means that the LDT (and laboratory manufacturing it) are in violation of the Federal Food, Drug and Cosmetic (FDC) Act and implementing regulations and subject to penalties, but that FDA is choosing not to take enforcement action (In the preamble to the final rule, FDA states: “Although FDA is phasing out its current general enforcement discretion approach over a period of years, the phaseout policy does not in any way alter the fact that it is illegal to offer IVDs without complying with applicable requirements. Regardless of the phaseout timeline and enforcement discretion policies for certain IVDs discussed below, FDA retains discretion to pursue enforcement action for violations of the FD&C Act at any time.”)
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- All LDTs are illegal if they do not comply with FDA’s requirements for medical devices.
- FDA is choosing not to prosecute.
- FDA can change its mind, without prior notice.
What is an In Vitro Diagnostic (IVD) Device?
In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. The final rule amended this definition to include IVDs manufactured by a clinical laboratory.
What is a Device Manufacturer?
Due to this rule change, clinical laboratories are considered “manufacturers” of LDTs and subject to FDA regulations applicable to medical device manufacturers, and LDTs are subject to regulation as medical devices.
What kind of consulting support does Lighthouse Lab Services offer for this transition?
- FDA compliance guidance.
- Customized recommendations.
- Resources to help you navigate FDA requirements.