Erkang Ai, Ph.D.

Erkang Ai, Ph.D.

Hogan Lovells

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FDA to rescind laboratory developed test rule

FDA decided to rescind the LDT rule after declining to appeal a district court decision vacating it. The rule reflected FDA’s latest attempt to regulate LDTs under the same framework as IVDs, which FDA considers medical...more

8/14/2025  /  Centers for Medicare & Medicaid Services (CMS) , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Authority , Rulemaking Process , Statutory Interpretation

Federal court vacates FDA Laboratory Developed Test rule

Yesterday, the U.S. District Court for the Eastern District of Texas vacated the U.S. Food and Drug Administration’s 2024 rule that aimed to regulate laboratory-developed tests (LDTs) as medical devices, deciding it is...more

4/2/2025  /  Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Regulatory Authority , Regulatory Requirements
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