Ms Tina Papagiannopoulos

Tina Papagiannopoulos

Updates

Healthcare & Life Sciences

FDA proposes regulatory framework for laboratory-developed tests
USA | 22 February 2017

In an unusual move, the Food and Drug Administration (FDA) recently published a discussion paper which proposes a new regulatory framework for laboratory-developed tests. The discussion paper describes a risk-based approach that differs significantly from the FDA's initial proposal in a draft guidance document issued in 2014 and reflects a lighter touch for most laboratory-developed tests.