Manufacturers, Laboratory Developed Tests, Life Sciences

FDA Signals to Industry to Prepare for Compliance with the LDT Final Rule Despite Looming Legal Challenge

Wilson Sonsini Goodrich & Rosati on 7/3/2024

The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more

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

Sheppard Mullin Richter & Hampton LLP on 5/1/2024

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

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

McDermott+ on 5/1/2024

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

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on 10/31/2023

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

Sheppard Mullin Richter & Hampton LLP on 10/19/2023

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”). The...more

Manufacturers › Laboratory Developed Tests › Life Sciences

FDA Signals to Industry to Prepare for Compliance with the LDT Final Rule Despite Looming Legal Challenge

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

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

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

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