First Lawsuit Against FDA’s LDT Rule Wants a New Designation for LDTs
(Thursday, May 30, 2024) As expected and promised, the FDA got sued this week for the new LDT Rule. In its latest attempt to regulate Lab Developed Tests (LDT), the FDA designated all such tests as conventional in vitro diagnostic (IVD) tests that require registration and formal approval or clearance by the FDA as a medical device. The lawsuit challenges this basic premise of the Final Rule, and if successful, may create a new designation for LDTs. Regulation of LDTs has been a sore issue for the last decade where the FDA and the labs offering LDTs have repeatedly disagreed on the process for FDA regulation of these tests while their use has exploded. The FDA tried several ways to create a formal regulatory pathway for LDTs and got pushed back on all fronts. It could not convince Congress to pass new legislation or convince the industry to accept tiered regulation. Doctors and patients, meanwhile, have come to increasingly depend on these tests. The FDA’s arguments to support the new Rule are fraught with non-scientific and anecdotal evidence. Multiple trade groups and other stakeholders strongly objected to the new Rule when proposed with more than 6000 comments submitted to the FDA, which the FDA decided to mostly ignore when it released the final Rule about a month ago in late April. And, as promised, one of the trade groups, the American Clinical Laboratory Association (ACLA), filed a lawsuit this week to challenge the new LDT Rule. The LDT lawsuit makes a very creative argument that LDTs are not tangible products that could be regulated by the FDA. Rather, the plaintiffs argue that LDTs are “professional services” and hence, outside the FDA’s jurisdiction. The Food Drug and Cosmetics Act (FDCA), specifies the FDA regulate “physical products that are mass-manufactured and commercially distributed”. The definition of medical devices in the FDCA is “tangible, physical products” and not “professional services”. “Laboratories that develop and perform these tests are providing professional healthcare services; they are not acting as device manufacturers or distributing devices”. According to the description proposed in the ACLA lawsuit, if accepted by the court, LDTs should be redesignated as Laboratory Developed Testing Services (LDTS), rather than just LDTs. This is the first challenge to the FDA’s Final Rule for LDTs. It is likely that additional parties may join the case, or file their own challenges. This issue is far from over and will be likely settled by the courts. The immediate outcome of the lawsuit could be that the court puts a stay on the implementation of the LDT Rule while it reviews the merits of the case, which could mean that dates proposed by the FDA will be moot. The complaint is a great read on the history of the LDT regulation over time. For now, the LDT labs should be in a wait-and-see mode. ![]() AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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