Facing the Inevitable: Being Prepared for Regulatory Requirements for Laboratory Developed Tests.

Abstract

We introduce regulatory terms, definitions, and the Quality System Regulation as proposed by the US Food and Drug Administration in the 2014 draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests and explore medical device requirements applicable to a laboratory environment to design, develop, and validate laboratory developed tests (LDTs). We performed nine interviews with laboratory professionals to explore concerns and challenges regarding the draft, translat