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Medical Devices › CLIA › Laboratory Developed Tests

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

Ropes & Gray LLP

Regulation of Laboratory Developed Tests in APAC

Ropes & Gray LLP on

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

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

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A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

Troutman Pepper Locke

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

Troutman Pepper Locke on

After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more

Venable LLP

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

Venable LLP on

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more

Goodwin

FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests

Goodwin on

On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its...more

Alston & Bird

What’s in the FDA Final Rule Regulating Laboratory-Developed Tests as Medical Devices?

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Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs)....more

Holland & Knight LLP

FDA's Final Rule on Laboratory Developed Tests Comes with Controversy and Concerns

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) recent announcement of a final rule extending regulatory oversight to laboratory developed tests (LDTs) has sparked controversy. As discussed in a previous Holland & Knight alert,...more

Foley Hoag LLP

FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests

Foley Hoag LLP on

On April 29, 2024, FDA finalized the long-awaited rule to assert authority over the regulation of laboratory developed tests (LDTs) under FDA’s existing regulatory framework for medical devices under the Federal Food, Drug,...more

ArentFox Schiff

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

ArentFox Schiff on

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more

Paul Hastings LLP

From General Discretion to Agency Authority? FDA’s Bold Bid to Regulate Laboratory Developed Tests

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After years of FDA discussion and failed congressional efforts to assert greater oversight of laboratory developed tests (LDTs), FDA has proposed a rule that would require many LDTs to comply with FDA’s requirements for in...more

Akin Gump Strauss Hauer & Feld LLP

FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

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On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

McDermott Will & Schulte

Laboratory-Developed Tests: FDA Publishes Highly Anticipated Proposed Rule

McDermott Will & Schulte on

On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more

King & Spalding

FDA's Latest Salvo in the LDT Wars

King & Spalding on

On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

Skadden, Arps, Slate, Meagher & Flom LLP on

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more

Knobbe Martens

FDA Pre-cert Program for Lab-Developed Tests

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The FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the tests themselves....more

Foley & Lardner LLP

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

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Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

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