Often, a lab will choose to develop and use an LDT because a commercial test is not currently available. There can be several reasons why a commercial test has not been developed for a particular analyte or disease of interest. The cornerstones of accreditation: validation, reference materials, and proficiency testing are discussed from an alternative method perspective.Best practices are discussed in a practical, usable fashion. Available online at Devices/Productsand Medical Procedures/Device Approvalsand Clearances/HDEApprovals/ucm161827 Regulatory Explainer: Making Sense of Humanitarian Use Devices. Director, Center for Devices and Radiological Health, U. Food and Drug Administration, Statement on Examining the Regulation of Diagnostic Tests and Laboratory Operations before Committee on Energy and Commerce Subcommittee on Health.
Available online at Devices/Productsand Medical Procedures/Device Approvalsand Clearances/PMAApprovals/ucm439050
For example, many LDTs are genetic tests that are developed for rare diseases, such as Huntington disease.
These are diseases that only a small subset of the population has, reducing the incentive for a manufacturer to develop a commercial version because the market for such a product would be small and not offer much, if any, return on investment. Our Industry and Technology, Uses of Diagnostic Tests.
Available online at https://edu/research/clinical-laboratory-testing.
Available online at https://gov/clia/Resources/Test
Medical Device Exemptions 510(k) and GMP Requirements.