In an unusual move, the Food and Drug Administration (FDA) published a discussion paper on January 13, 2017 entitled “Discussion Paper on Laboratory Developed Tests”, 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 The discussion paper describes a risk-based approach that differs significantly from the FDA’s initial proposal in a draft guidance document issued in 2014 and reflects a lighter touch for most laboratory-developed tests.
International Law Office
FDA Proposes Regulatory Framework for Laboratory-Developed Tests
February 22, 2017