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- Title
Laboratory developed tests.
- Authors
Wichmann, Christina
- Abstract
The article focuses on the U.S. Food and Drug Administration's (FDA) plan to release a proposed rule in August 2023 regarding the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic devices used within a single laboratory. Topics discussed include the FDA's intention to categorize LDTs as medical devices, the regulatory history and context surrounding LDTs, and the potential impact of the proposed rule on clinical laboratories.
- Subjects
CLINICAL pathology; LABORATORY equipment &; supplies; PATHOLOGICAL laboratories; INDUSTRIAL property; SERIAL publications; GOVERNMENT regulation; UNITED States. Food &; Drug Administration
- Publication
Medical Laboratory Observer (MLO), 2023, Vol 55, Issue 10, p4
- ISSN
0580-7247
- Publication type
Article