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Regulatory Requirements › Medical Devices › CLIA

Troutman Pepper

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

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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

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