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Clinical Laboratories › Enforcement Actions › Food and Drug Administration (FDA)

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

Gardner Law on

In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

Akin Gump Strauss Hauer & Feld LLP

Checking In On FDA’s Enforcement Discretion Policy for Laboratory Developed Tests

Akin Gump Strauss Hauer & Feld LLP on

• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more

Bass, Berry & Sims PLC

FDA Warns Against Direct-to-Consumer Lab Developed Tests

Bass, Berry & Sims PLC on

Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more

Hogan Lovells

FDA resumes enforcement relating to laboratory developed tests

Hogan Lovells on

On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory in one of the first FDA enforcement...more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

Holland & Knight LLP on

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

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