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Life Sciences › Federal Food Drug and Cosmetic Act (FFDCA) › Clinical Laboratories

Hogan Lovells

First salvo fired against FDA’s laboratory developed test rule

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In the Eastern District of Texas U.S. federal court, the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, have filed a lawsuit against the Food and Drug Administration (FDA), claiming the...more

Goodwin

Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests

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On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests...more

Venable LLP

Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"?

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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). This action...more

Goodwin

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

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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

Husch Blackwell LLP

Discretion No More: FDA’s New Final Rule Regulating Laboratory Developed Tests

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On April 29, 2024, the Food and Drug Administration (FDA) announced a Final Rule amending regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act...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

Holland & Knight LLP

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

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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

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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

BakerHostetler

FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests

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The U.S. Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed tests (LDTs). LDTs are in vitro diagnostic products (IVDs) that...more

Holland & Knight LLP

FDA Announces Final Regulation Governing Laboratory Developed Tests

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The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices....more

Sheppard Mullin Richter & Hampton LLP

FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests

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Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous...more

McDermott+

FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices

McDermott+ on

On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs) that FDA describes as...more

Manatt, Phelps & Phillips, LLP

Congress Revisits Longstanding Debate Over FDA Regulation of Lab-Developed Tests

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On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” In the wake of...more

Epstein Becker & Green

What’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory...

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The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more

Hogan Lovells

FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

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U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...more

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