FDA Moves Forward on Laboratory Developed Tests

Following years of discussion and debate, the FDA officially published its final rule covering laboratory developed tests (“LDTs”) on May 6, 2024. LDTs are defined as “in-vitro diagnostic products (“IVDs”) that are intended for clinical use and are designed, manufactured, and used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meets the regulatory requirements under CLIA to perform high complexity testing.” Previously, the FDA had exercised general enforcement discretion with respect to most LDTs which in essence meant that such devices were not expected to comply with many premarket and postmarket regulatory requirements. However, with the growing prevalence of such devices coupled with increasing complexity over the years, the FDA will be phasing-out its general enforcement discretion for LTDs. This phase-out will serve to correct the imbalance that existed in oversight between non-laboratory and laboratory IVD manufacturers. The phase-out will be implemented in 5 stages over a 4-year period as follows:

• Stage 1: beginning on May 6, 2025, the FDA will enforce compliance with medical device reporting requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files.
• Stage 2: beginning on May 6, 2026, the FDA will enforce compliance with requirements not covered during other stages of the phase-out policy, including registration and listing requirements, labeling requirements, and investigational use requirements.
• Stage 3: beginning on May 6, 2027, the FDA will enforce compliance with QS requirements (other than requirements regarding complaint files which are already addressed in stage 1).
• Stage 4: beginning on November 6, 2027, FDA will enforce compliance with premarket review requirements for high-risk IVDs offered as LDTs (IVDs that may be classified into class III or that are subject to licensure under section 351 of the Public Health Service Act), unless a premarket submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.
• Stage 5: beginning on May 6, 2028, the FDA will enforce compliance with premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs (that require premarket submissions), unless a premarket submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.

The final rule details certain exceptions to the phase-out implementation regarding a subset of LDTs including those that were not subject to the general enforcement discretion approach such as certain blood donor screening tests, direct-to-consumer tests, and tests used in public health emergencies.

Further, the final rule modifies the definition of IVDs to make it clear that LDTs are included and subject to FDA oversight and regulation. The new definition reads as follows:

“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. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act, including when the manufacturer of these products is a laboratory.” 

As a result of this final rule, manufacturers of LDTs are officially on notice! While litigation challenging enforcement of this rule is possible, regulatory and quality leaders will need to act quickly to identify any gaps with their current practices and procedures as compared to the vast requirements within the applicable FDA regulations. For instance, many companies will now need to implement and maintain strict protocols to address adverse event reporting, establishment registration and device listing, labeling standards, investigational use requirements, CGMPs, and premarket reviews. The final rule is over 500 pages and needs to be navigated carefully to ensure a thorough understanding of all actions needed.

If you need any assistance understanding, implementing, or maintaining compliance with this final rule, please reach out to us for help!

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