A Quick Look at the Evolving Legal and Legislative Situation Surrounding the FDA's LDT Final Rule
A Quick Look at the Evolving Legal and Legislative Situation Surrounding the FDA's LDT Final Rule
Regulatory attorney Christine P. Bump gave an informative breakdown of the implications of recent judicial and legislative activity potentially impacting the FDA's Final Rule on LDTs.
This morning, in a webinar hosted by Ideagen, regulatory attorney Christine Bump gave a comprehensive overview of the FDA’s Final Rule regulating LDTs as medical devices in the context of the latest judicial and legislative activity.
The full webinar is currently available for replay here.
We summarized the state of play below.
I.
Since the FDA's Final Rule on LDTs was issued in May, it’s become a focal point of controversy and legal challenges. The rule aims to bring LDTs under the same regulatory umbrella as other medical devices. Under it, the FDA is phasing out its general enforcement discretion approach to LDTs. During a four-year phase-out period, the FDA will "phase in" regulatory compliance expectations for certain types of IVDs offered as LDTs in five stages.
Each stage adds additional layers of compliance expectations over time, with which clinical laboratories using LDTs will need to comply. These requirements are not new; they are regulatory tools already applied in enforcement against traditional IVD manufacturers: adverse event reporting, establishment registration and device listing, labeling standards, investigational use requirements, and, as new IVDs enter the market or are significantly modified, CGMPs and premarket review.
The Final Rule applies these requirements in a five-stage "ramp-up" approach over the next four years as follows:
Stage 1: Within 1 year (by May 6, 2025), the FDA expects compliance with medical device reporting (MDR) and Quality System Regulation (QSR) compliance under 21 CFR §820.198 (complaint files).
Stage 2: Within 2 years (by May 6, 2026), the FDA expects compliance with registration and listing requirements, including labeling, and compliance with investigational use requirements.
Stage 3: Within 3 years (by May 6, 2027), the FDA expects compliance with full QSR at 21 CFR Part 820.
Stage 4: Beginning at 3.5 years (by November 6, 2027) after publication, FDA will require compliance with premarket review for high-risk IVDs offered as LDTs. Enforcement discretion will continue for any application for Class III PMA or 351(a) PHSA BLA for/including an IVD received before the 3.5-year mark.
Stage 5: Beginning 4 years after publication (by May 6, 2028), the FDA will require premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs requiring pre-market submission. Enforcement discretion will continue for any submission received by the FDA before the 4-year mark.
However, its path forward is far from clear, with a flurry of legal, legislative, and judicial developments creating a complex web of uncertainty.
II.
At the forefront of the opposition stands the American Clinical Laboratory Association (ACLA), which filed a lawsuit against the FDA in the U.S. District Court for the Eastern District of Texas on May 29, 2023. The crux of their argument: That the FDA has overstepped its statutory authority, and the rule violates the Administrative Procedures Act. Both parties have requested a summary judgment, setting the stage for a potential decision by early 2025.
Adding to the regulatory turbulence, the Supreme Court's June 28 decision in the Loper Bright case overturned the long-standing Chevron doctrine. This landmark ruling removes the requirement for courts to defer to agency interpretations of ambiguous statutes, potentially weakening the FDA's position in defending the LDT Final Rule.
Congress, too, has entered the fray. A joint resolution to nullify the rule under the Congressional Review Act fell short when President Biden declined to sign it by the July 5 deadline. However, the legislative branch continues to exert pressure. Senator Cassidy has questioned the FDA's authority in light of the Loper Bright decision, while Senator Warren introduced the "Stop Corporate Capture Act" in an attempt to codify agency deference into law.
Perhaps most tellingly, the House Appropriations Committee approved a budget on July 10 that explicitly instructs the FDA to suspend implementation of the LDT Final Rule. Instead, they've directed the agency to work with Congress on a new regulatory approach, possibly hinting at a revival of the VALID Act — a comprehensive framework for all diagnostic tests that has been languishing in committee since April 2023.
III.
Despite these challenges, the FDA's rule remains in effect, with the crucial Stage 1 compliance deadline of May 6, 2025, looming on the horizon. This first phase requires laboratories to implement systems for medical device reporting, corrections and removals, and complaint files — no small task for many facilities. (We are already contracting with impacted labs to put these measures in place to ensure compliance ahead of the deadline. The demand for specialized consultants is extremely high. Contact us if you haven’t secured support resources yet.)
So, what's a laboratory to do in this uncertain regulatory environment? The consensus among experts is clear: prepare, but proceed with caution. Legislative changes are unlikely to materialize before the Stage 1 deadline. The upcoming 2024 election and ongoing legal challenges could yet alter the landscape. The most likely scenario for halting the Stage 1 implementation would be a favorable summary judgment for ACLA in the Texas lawsuit. We recommend keeping an eye on their newsroom for updates if they come to pass.
In the meantime, laboratories face a difficult balancing act. They must weigh the costs and efforts of compliance preparation against the risk of being caught unprepared if the rule stands. It's a business decision that depends on each laboratory's individual risk tolerance and resources.
From our perspective as one of the relatively few firms with professional networks that include the specialized professionals qualified to help labs plan and execute a compliance program against the Final Rule, we urge any firm pursuing compliance to move quickly to arrange for the support they need. We have the Regulatory and Quality consultants required to put the necessary pieces in place for the first phase’s requirements, with a project schedule that’s filling up between now and the end of the year.
Read our compliance guide to orient yourself against the Final Rule, and contact us to get the conversation started.
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