Sep 10, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs. UDIs also will apply to certain combinations of products that contain devices...
