Standard Document
First Edition
Method Evaluation
CLSI LDTStage1
LDT Regulatory Guidance
The US Food and Drug Administration (FDA) 21 CFR Parts 820.198, 803, and 806 requirements apply to enforcement discretion for laboratory-developed tests (LDTs), scheduled to take effect on 6 May, 2025. This document provides guidance for laboratories preparing to adhere to the FDA requirements when establishing and implementing LDTs.
March 10, 2025
Lucia M. Berte, MA, MLS(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE
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LDTStage1E
978-1-68440-276-2
20