On May 6, the Food and Drug Administration (FDA) published a final rule setting out a new regulatory framework that phases out enforcement discretion over a four year period for laboratory developed tests (LDTs) by defining them as in vitro diagnostics (IVDs) thus making them subject to regulation as devices. ABC submitted comments to FDA on this rule encouraging FDA to carve out blood centers and the types of tests they perform. While FDA did include multiple exclusions that would benefit blood centers, there are still tests relevant to blood centers that would be included in this regulatory change.
Implementation Timeline
There are 5 main stages related to implementation of the final rule:
- Stage 1 (as of May 6, 2025): Compliance with medical device reporting requirements, correction and removal reporting requirements and quality system (QS) requirements regarding complaint files is required;
- Stage 2 (as of May 6, 2026): Compliance with registration and listing requirements, labeling requirements and investigational use requirements, as well as other requirements not covered in other portions of the phase in.
- Stage 3 (as of May 6, 2027): Compliance is required for the remaining QS requirements (not covered in stage 1).
- Stage 4 (November 6, 2027): Requires compliance with premarket review requirements for high-risk IVDs.
- Stage 5 (as of May 6, 2028): Compliance with premarket review for moderate-risk and low-risk IVDs offered as LDTs.
Lawsuits
As expected, we have seen two major lawsuits filed challenging the legality of this rule. The first lawsuit was brought by the American Clinical Laboratory Association (ACLA), whose members include major lab companies such as LabCorp and Quest Diagnostics. This lawsuit was filed on May 29, 2024 in the US District Court in the Eastern District of Texas. A second lawsuit was filed by the Association for Molecular Pathology (AMP) on August 19 in the US District Court for the Southern District of Texas.
The suits filed to date center around two main arguments: (1) FDA does not have the authority to regulate LDTs and (2) FDA violated the Administrative Procedures Act in failing to adequately respond to all comments and provide sufficient justification for the approach selected.
It is notable that both suits were filed in different federal district courts in Texas, where the jurisdictions selected are known to be sympathetic to arguments of regulatory overreach. It also appears clear that FDA anticipated litigation in this case, as the final rule includes extensive legal reasoning and analysis that lays out its likely arguments for litigation.
Impact of the Chevron Ruling
Since the initial publication of the final rule, the Supreme Court has overturned the doctrine of Chevron deference, potentially impacting the way the courts decide these cases. With Chevron overturned, when ruling on the respective lawsuits, the courts will no longer defer to FDA’s reasoning, but will instead weigh both side’s arguments, and issue a judgment based on the court’s independent judgment as to whether FDA has the authority to regulate LDTs.
What Do We Expect Next?
We anticipate one of the parties may request a preliminary injunction, putting implementation of the rule on hold during the course of litigation. Issuing a preliminary injunction requires showing substantial likelihood of success on the merits and irreparable harm that cannot be remedied by damages awardable by the court.
At this time, neither ACLA nor AMP have filed for a preliminary injunction. It is likely ACLA was awaiting the Supreme Court’s overturning of Chevron deference, which occurred about a month after the lawsuit was filed, to avoid the court issuing a decision based on Chevron. It may be possible that ACLA and/or AMP are gathering information to demonstrate the impact of compliance from their membership to support such a motion. Of course, they also may not intend to file for injunctive relief.
Congressional Action
Over the past decade, Congress has considered bills that would have provided FDA explicit authority to regulate LDTs, most recently with the Verifying Accurate Leading-edge IVCT Development (VALID) Act, but none have been signed into law. ABC has worked with Congress to ensure they understand how blood centers utilize LDTs, and how regulation would impact the availability of these important tests. We were successful in achieving important carveouts in the VALID Act for many of the LDTs utilized by blood centers as a part of normal operations. Even after the promulgation of the LDT rule, we have seen Congress continue to engage in discussions about potential legislation providing FDA authority to regulate LDTs.
Blood Center Implementation
As we are all aware, litigation tends to take a long time to be resolved. We anticipate these cases may take years to conclude. The challenge for blood centers is knowing whether (and how) to move forward with compliance activities and unfortunately, there is not a clear answer at this time. In the meantime, blood centers should determine their timeline and begin any activities to comply with the FDA rule.
Questions? Contact Diane Calmus, Vice President of Government Affairs, at dcalmus@americasblood.org.