On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests (IVDs), including laboratory developed tests (LDTs), are devices regulated under the Federal Food, Drug and Cosmetic Act.
LDTs have increased in volume, complexity and importance in critical healthcare decision-making since 1976 when the Medical Device Amendments (MDA) were passed and FDA began exercising enforcement discretion. Accordingly, FDA has advised that increased oversight is needed for LDTs. However, some specific categories of LDTs will be covered under new targeted enforcement discretion policies.
As explained in the final rule, examples of LDTs covered under new targeted enforcement discretion policies include, for example, currently marketed IVDs offered as LDTs, LDTs for unmet needs when prescribed and administered within the same health system, certain HLA tests, "1976-type LDTs" and tests administered for law enforcement purposes. Per FDA, 1976-type LDTs are tests performed manually and without automation, such as cystic fibrosis sweat tests. This list of LDTs is expanded from the list in the notice of proposed rulemaking.
The final rule, which is effective July 5, 2024, will also begin a four-year, five-step phaseout process of FDA's general enforcement discretion approach for LDTs. FDA advises that the process will be as follows:
- Stage 1: Beginning May 6, 2025, compliance with medical device reporting (MDR), correction and removal reporting and quality system (QS) requirements regarding complaint files;
- Stage 2: Beginning May 6, 2026, compliance with other regulatory requirements, including registration and listing requirements, labeling requirements and investigational use requirements;
- Stage 3: Beginning May 6, 2027, compliance with all QS requirements other than complaint files addressed in Stage 1;
- Stage 4: Beginning November 6, 2027, high-risk IVDs offered as LDTs must be in compliance with premarket review requirements;
- Stage 5: Beginning May 6, 2028, moderate- and low-risk IVDs offered as LDTs must comply with premarket review requirements.
FDA presented a webinar on May 14, 2024, providing an overview of the final rule and phaseout process.
During the webinar, FDA emphasized that currently marketed LTDs should not be thought of as "grandfathered in." Rather, FDA will generally use enforcement discretion if, after May 6, 2024, the LTD does not undergo changes that could affect its basic safety and effectiveness profile. Those changes will trigger premarket review and QS requirements for currently marketed LTDs. FDA defines these changes as changes:
- To the use indication of the IVD;
- That alter the operating principle of the IVD;
- Include significantly different technology in the IVD; or
- Adversely change the performance or safety specifications of the IVD.
FDA clarified that there will be no enforcement discretion for small labs and noted that premarket submission requirements will not change based on the size of the manufacturer.
FDA explained that the rule is not intended to constrain a healthcare provider's decision-making, which may include ordering an IVD for a use outside of its indicated use.
FDA indicated that it will host additional webinars in the coming months, covering draft guidelines for certain IVDs before and during the declaration of a public health emergency, IVD classification and MDRs.
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