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Rulemaking Process › Federal Food Drug and Cosmetic Act (FFDCA) › Laboratory Developed Tests

Hogan Lovells

FDA to rescind laboratory developed test rule

Hogan Lovells on

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

Akin Gump Strauss Hauer & Feld LLP

FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

Akin Gump Strauss Hauer & Feld LLP on

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

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