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 ).

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

The Pharma Data

AUGUST 4, 2020

This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. The test offers an alternative to lab-developed tests (LDTs) or Assay Specific Reagents (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories.

DNA 52

DNA In-Vitro Medicine Reagent 52

The Pharma Data

SEPTEMBER 7, 2020

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. BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications.

In-Vitro 52

In-Vitro Medicine Reagent DNA 52