On May 6, 2024, the US Food and Drug Administration (FDA) issued the Final Rule regarding regulation of laboratory developed tests (LDTs). The LDT Final Rule outlines a four-year phaseout period for the enforcement discretion approach that FDA has previously exercised for LDTs.
The scope of this phaseout policy includes in vitro diagnostics (IVDs) that are manufactured and offered as LDTs by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. FDA contends that it has always had regulatory authority over LDTs, but historically chose to exercise enforcement discretion. Issuing the Final Rule officially started the clock on the gradual phaseout of FDA’s general enforcement discretion approach regarding LDTs.
The phaseout is strategically spread across five phases intended to provide clinical labs sufficient time to bring their processes into compliance. Following the issuance of the LDT Rule, FDA has moved forward with implementation of the phaseout policy, conducting public webinars, issuing initial directional guidance documents, and publishing answers to FAQs from impacted laboratories. However, at the same time there have been several challenges raised regarding the LDT Rule. The American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, filed a lawsuit against FDA arguing that the agency lacks the authority to regulate LDTs as medical devices. On August 19, 2024, the Association for Molecular Pathology (AMP) filed a similar lawsuit laying out their argument for vacating the LDT Rule. Other industry associations have published statements and arguments supporting similar claims as the ACLA and AMP lawsuits, recommending sole regulatory oversight by CLIA continue. The Legislative response has mostly been split by political party, but individual congressman and congressional committees have added their voices to the mix, challenging or supporting the LDT Rule.
Stage 1 of the phaseout policy includes expectations for compliance with regulations for medical device reporting, correction and removal reporting, and quality system (QS) requirements for complaint files. With the Stage 1 enforcement deadline scheduled for May 6, 2025 (one year after the LDT Final Rule publication date) many laboratories are unsure of next steps. Laboratories still have a lot of questions about the regulation, its requirements, and concerns about investments into implementation with the uncertainty that remains. Some common questions, we hear:
If you are wondering how your specific organization and offerings are impacted by the phaseout of enforcement discretion, below are some suggested areas to review.
Evaluate your current products, product developments, or future pipeline products for applicability of the FDA LDT Rule. Assess each product or service offering against the available FDA product classification categories and against the exceptions listed within the LDT Rule. Document the classification and rationale for each offering assessed.
Perform a thorough assessment of your current Quality System relative to the FDA requirements of the phaseout plan. If your clinical laboratory is compliant with CLIA, we recommend prioritizing the areas where CLIA and FDA QMS regulations differ to identifying potential gaps and needed improvements. Where possible, leverage your existing procedures and processes and look for opportunities to make incremental improvements or enhancements in lieu of starting from the beginning. Document the approach in an implementation plan with specific actions, ownership, and timeline to meet the phaseout policy deadlines.
Develop a regulatory strategy for your product portfolio based on the product classification and aligned with the Stage 4 and Stage 5 phaseout policy dates. Be sure to consider the unique product characteristics (e.g., NY CLEP status, rare diseases, unmet needs, etc.) and premarket review requirements for your specific offerings. FDA recommends the least burdensome approach to regulatory submission, so employ these strategies in your premarket submission plan. If significant questions or clarifications exist regarding the regulatory pathway consider whether utilizing the FDA Q-sub program may be beneficial.
With your regulatory strategy in mind, review your performance claims and the available data that validates these claims. If there are data gaps, discrepancies, or other concerns about the suitability of performance data, consider whether a clinical study may be needed. Evaluate all available options for obtaining the clinical data necessary for your regulatory submission strategy. Although the Stage 4 and Stage 5 deadlines are several years away obtaining adequate and necessary performance data may require significant investment and time, so it is never too early to begin planning.
Consider providing formal training for key individuals, teams, or the broader organization on the LDT Rule and specific QS requirements such as Medical Device Reporting, Labeling Requirements, and/or Design Controls. Provide interactive sessions that help spread awareness and address any questions or concerns about potential impact. This approach will instill confidence that the organization has a defined roadmap to achieve required compliance.
Given that you must maintain business as usual during this transition, consider whether you need to hire an external partner, like ProPharma, to lead these efforts. With the ever-changing landscape of LDTs, it is important to have a knowledgeable and reliable partner that can assist you in navigating this new path.