FDA’s Unique Device Identifier Program for In Vitro Diagnostic Devices Used by Clinical Laboratories Set to Begin September 24

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...

Medical Home Concept Poised to be National Model, May Increase Utilization of Clinical Pathology Laboratory Testing

Medicare to do National Demonstration Project Involving Medical Homes Medical home pilot projects are being closely watched by pathologists and clinical laboratory managers. This is a new model of patient-centered care which has important advocates among primary care practitioners. If the medical home concept catches on, it may require clinical laboratories to provide laboratory testing services in a different way. In southeastern Pennsylvania, a medical-home pilot project is taking a...
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