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The page below is a sample from the LabCE course The Basics of Non-Conforming Event Management for Clinical Laboratory Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Laboratory-Developed Tests and the Food and Drug Administration (FDA)

Laboratory-developed tests (LDTs) are a category of in vitro diagnostic tests that are designed, manufactured, and used within a single laboratory.
Regulatory oversight of LDTs by the FDA has become quite controversial in recent years, with concerns for patient safety at the core of the discussion. Like drugs, all laboratory tests must demonstrate safety and effectiveness. Late in 2016, the FDA announced it will not issue final guidance on their proposed oversight of LDTs. While there is not a final version of the FDA's guidance documents, the FDA issued a Discussion Paper* on January 13, 2017 that maintains a risk-based approach. The prospective oversight proposes focusing on new and significantly modified high and moderate risk LDTs.
This relates to the CAPA process in that the responsibility for establishing and maintaining procedures for implementing corrective and preventive actions for LDTs lies with the laboratory which develops and validates the test. Clinical laboratories performing LDTs should have a formal CAPA program to ensure that clinical laboratory testing is of the highest possible quality and validity. Your CAPA program is designed to help achieve this goal.
*Food and Drug Administration. Discussion Paper on Laboratory Developed Tests (LDTs). Available at: https://www.personalizedmedicinebulletin.com/wp-content/uploads/sites/6/2017/02/LDT_discussionpaper.pdf. Accessed April 13, 2017.