FDA's Framework for Regulatory Oversight of LDTs

摘要

The Food and Drug Administration (FDA) defines the term laboratory-developed test (LDT) as an in vitro diagnostic intended for clinical use and designed, manufactured, and used within a single laboratory. In prior years, local laboratories primarily developed LDTs. LDTs were typically used and interpreted directly by physicians and pathologists working within a single institution that was responsible for the patient. In addition, historically, LDTs were manufactured by using components that were generally marketed for clinical use.