Laboratory-developed tests and in vitro diagnostics: A regulatory overview for anatomic pathology
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DOI: 10.1093/ajcp/aqae181
Abstract: Abstract Objectives The US Food and Drug Administration’s Final Rule on laboratory-developed tests was published on May 6, 2024. The objective of this article is to explain the Final Rule and existing in vitro diagnostic… read more here.
Keywords: anatomic pathology; final rule; pathology; developed tests ... See more keywords
Facing the Inevitable: Being Prepared for Regulatory Requirements for Laboratory Developed Tests
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DOI: 10.1093/ajcp/aqy014
Abstract: Objectives 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terms, definitions, and the Quality System Regulation as proposed by the US Food and Drug Administration in the 2014 draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests and… read more here.
Keywords: developed tests; prepared regulatory; inevitable prepared; facing inevitable ... See more keywords
International Council for Standardization in Haematology (ICSH) Guidance on the Validation of Laboratory Developed Tests in Haemostasis
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DOI: 10.1111/ijlh.14502
Abstract: Laboratory developed tests (LDTs) are widely used in clinical hemostasis laboratories. An LDT may be defined as an in vitro diagnostic (IVD) test that is designed, manufactured, and used within a single laboratory. As with… read more here.
Keywords: international council; council standardization; laboratory; validation ... See more keywords