CLSI LDT Stage 1
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), which begins on May 6, 2025. This document intends to provide guidance for preparing a laboratory to adhere to the FDA requirements when establishing and implementing LDTs.
This document is available in electronic format only.
Member price:
List Price:Details
Chairholder: Lucia M. Berte, MA, MLS(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE
Date of Publication: March 10, 2025
Order Code PDF: CLSI LDTStage1E
ISBN Number: 978-1-68440-276-2
Order Code Print: print not available
Edition: First
Pages: 20