FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

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Regulation In-Vitro Manufacturing Licensing 81

The Pharma Data

AUGUST 4, 2020

Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. Test meets World Health Organization standards for consistent result reporting among laboratories across the U.S.,

DNA 52

DNA In-Vitro Medicine Reagent 52

The Pharma Data

SEPTEMBER 7, 2020

Food and Drug Administration (FDA) 510k clearance for the cobas® BKV Test on the cobas® 6800 and 8800 Systems. The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories.

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In-Vitro Medicine Reagent DNA 52