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Medical Devices › Clinical Laboratories › Healthcare

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

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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

Jones Day

Judge Blocks FDA Regulation of Laboratory-Developed Tests

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On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more

Akin Gump Strauss Hauer & Feld LLP

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

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On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

Polsinelli

Challenges to LDT Final Rule Continue as Rule Goes into Effect

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As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more

Bass, Berry & Sims PLC

Settlement Roundup: Heart-Valve Replacements, Federal Research Grants, and Clinical Laboratory Marketing

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The Department of Justice (DOJ) recently announced settlements involving alleged noncompliance with Medicare billing requirements for heart-valve replacement surgeries, false statements in federal funding research grants, and...more

Quarles & Brady LLP

FDA Publishes Final Rule on Regulation of Lab-Developed Tests

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On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

Epstein Becker & Green

FDA’s LDT Proposed Rule Heads to the White House

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As discussed in our June Insight, earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s...more

Latham & Watkins LLP

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

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In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

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