Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Over the last several years, federal concern about genetic testing has been steadily growing. Regulators have watched Medicare Part B spending on molecular and genetic tests spike while a relatively small number of...more
The Centers for Medicare and Medicaid Services (CMS) issued a Request for Information (RFI) on February 27, 2026, that signals a potential expansion of federal health care fraud, waste, and abuse enforcement. While the RFI...more
On January 28, 2026, the U.S. Department of Health and Human Services Office of Inspector General (“HHS OIG”) released a report, “Total Medicare Part B Spending on Lab Tests Rose in 2024, Driven by Increased Spending on...more
Introduction On January 28, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a new report analyzing Medicare Part B (Part B) spending on laboratory tests in 2024....more
The final quarter of 2025 saw continued enforcement actions against clinical labs and other related healthcare entities. The Office of Inspector General (OIG) and Department of Justice (DOJ) heavily focused on False Claims...more
The Food and Drug Administration (FDA) has begun 2026 with a clear signal to the direct‑to‑consumer testing industry: self‑collection devices remain firmly within the agency’s regulatory reach, notwithstanding the 2025 court...more
After years of delays, the Centers for Medicare & Medicaid Services (CMS) is preparing to update the Clinical Laboratory Fee Schedule’s (CLFS) reimbursement rates for clinical diagnostic laboratory tests (CDLTs) that aren’t...more
The U.S. Court of Appeals for the First Circuit has weighed in on Omni Healthcare, Inc.’s (Omni) False Claims Act (FCA) allegations against MD Labs, issuing a decisive win for the defendant. On December 1, 2025, a unanimous...more
The U.S. Department of Justice recently announced a settlement with Patients Choice Laboratories (“PCL”), a diagnostic laboratory headquartered in Indianapolis, Indiana, under which PCL will pay over $9.6 million to resolve...more
On July 2, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-07, which concluded that a pharmaceutical manufacturer’s proposed arrangement to sponsor a free,...more
An artificial intelligence (AI) triage model piloted in the emergency department can become a deterioration predictor on med-surg floors and then prioritized on a radiology worklist. A lab‑developed sepsis panel built in the...more
In a major regulatory reversal, the U.S. Food and Drug Administration (FDA) has officially rescinded its 2024 final rule that sought to regulate Laboratory Developed Tests (LDTs) as medical devices. The decision, announced on...more
Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that. Multiple lawsuits were...more
Laboratory-developed tests (“LDTs”) are in vitro diagnostic (“IVDs”) products designed and used within a single clinical laboratory to perform high complexity testing. ...more
The United States Food and Drug Administration (FDA) has officially rescinded its final rule proposing to regulate Laboratory Developed Tests (LDTs) as medical devices. On Sept. 19, 2025, FDA issued a new final rule reverting...more
Expected New Drug Pricing Model: We anticipate the Centers for Medicare & Medicaid Services (CMS) to release a significant proposed new drug pricing model through its Innovation Center called the Global Benchmark for...more
Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions. ...more
On Tuesday, September 23, 2025, FDA published guidance titled “Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency.” The guidance, a draft of which was published on May...more
Earlier this month, the Office of Information and Regulatory Affairs (OIRA) updated its list of rules pending review under Executive Order 12866 to include FDA's request to rescind its controversial Laboratory Develop Test...more
FDA decided to rescind the LDT rule after declining to appeal a district court decision vacating it. The rule reflected FDA’s latest attempt to regulate LDTs under the same framework as IVDs, which FDA considers medical...more
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more
As the song goes, the Food and Drug Administration’s (“FDA’s”) 2024 Final Rule regulating laboratory-developed tests (“LDTs”) as medical devices (“Final Rule”), is not merely dead—it’s really most sincerely dead....more
Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more
On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...more
On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment...more