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Life Sciences › CLIA › Final Rules

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

Husch Blackwell LLP

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

Husch Blackwell LLP on

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

Alston & Bird

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

Alston & Bird on

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

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